{"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.95003,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":347,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01167,"AVALU":"YEARS","ADTM":"2020-03-13 05:28:11","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20461,"AVALU":"YEARS","ADTM":"2020-05-22 05:28:11","ADY":75,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00229,"AVALU":"YEARS","ADTM":"2020-03-09 05:28:11","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":52.14286,"AVALU":"WEEKS","ADTM":"2021-03-07 20:23:04","ADY":365,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-105","SUBJID":"id-105","SITEID":"BRA-1","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.15691,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-08 05:28:11","TRTEDTM":"2021-02-17 18:49:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":347,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":5.42857,"AVALU":"WEEKS","ADTM":"2020-04-14 04:26:13","ADY":38,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-04 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.22029,"AVALU":"YEARS","ADTM":"2021-01-24 03:50:33","ADY":81,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-05 03:50:33","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-05 03:50:33","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42.42857,"AVALU":"WEEKS","ADTM":"2021-08-27 20:49:40","ADY":297,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-134","SUBJID":"id-134","SITEID":"BRA-1","AGE":47,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":6.46299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-03","TRTSDTM":"2020-11-04 03:50:33","TRTEDTM":"2022-11-04 15:28:57","EOSSTT":"COMPLETED","EOSDT":"2022-11-04","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.14286,"AVALU":"WEEKS","ADTM":"2022-06-01 15:33:10","ADY":575,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-26 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.21887,"AVALU":"YEARS","ADTM":"2020-10-13 14:10:56","ADY":80,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18271,"AVALU":"YEARS","ADTM":"2020-09-30 14:10:56","ADY":67,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-27 14:10:56","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":92.85714,"AVALU":"WEEKS","ADTM":"2022-05-05 09:22:28","ADY":650,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-141","SUBJID":"id-141","SITEID":"BRA-1","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.51608,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-22","TRTSDTM":"2020-07-25 14:10:56","TRTEDTM":"2022-07-26 01:49:20","EOSSTT":"COMPLETED","EOSDT":"2022-07-26","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":62,"AVALU":"WEEKS","ADTM":"2021-10-01 17:48:21","ADY":434,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-16 08:37:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.1432,"AVALU":"YEARS","ADTM":"2021-03-09 08:37:05","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.21391,"AVALU":"YEARS","ADTM":"2021-04-04 08:37:05","ADY":79,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":93,"AVALU":"WEEKS","ADTM":"2022-10-27 18:46:10","ADY":651,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-236","SUBJID":"id-236","SITEID":"BRA-1","AGE":32,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.663,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 08:37:05","TRTEDTM":"2023-01-15 20:15:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":44.28571,"AVALU":"WEEKS","ADTM":"2021-11-20 10:10:43","ADY":310,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.35524,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":495,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":11} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07412,"AVALU":"YEARS","ADTM":"2019-11-04 15:01:52","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.35124,"AVALU":"YEARS","ADTM":"2020-02-13 15:01:52","ADY":129,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02256,"AVALU":"YEARS","ADTM":"2019-10-16 15:01:52","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":92.71429,"AVALU":"WEEKS","ADTM":"2021-07-16 20:51:11","ADY":649,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-265","SUBJID":"id-265","SITEID":"BRA-1","AGE":25,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":10.32335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-03","TRTSDTM":"2019-10-07 15:01:52","TRTEDTM":"2021-02-12 05:47:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":494,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":23.28571,"AVALU":"WEEKS","ADTM":"2020-03-17 16:47:29","ADY":163,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-31 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.43683,"AVALU":"YEARS","ADTM":"2020-06-09 21:08:39","ADY":160,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-01 21:08:39","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06523,"AVALU":"YEARS","ADTM":"2020-01-25 21:08:39","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":53.28571,"AVALU":"WEEKS","ADTM":"2021-01-07 23:36:15","ADY":373,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-42","SUBJID":"id-42","SITEID":"BRA-1","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":2.26754,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-31","TRTSDTM":"2020-01-01 21:08:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-01-01 21:08:39","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-15 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.15364,"AVALU":"YEARS","ADTM":"2019-09-10 12:56:41","ADY":57,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.05218,"AVALU":"YEARS","ADTM":"2020-08-03 12:56:41","ADY":385,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11173,"AVALU":"YEARS","ADTM":"2019-08-25 12:56:41","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42.85714,"AVALU":"WEEKS","ADTM":"2020-05-09 07:13:43","ADY":300,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-65","SUBJID":"id-65","SITEID":"BRA-1","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.34092,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-15 12:56:41","TRTEDTM":"2021-07-15 00:35:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-15","EOSDY":731,"LSTALVDT":"2021-07-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":30,"AVALU":"WEEKS","ADTM":"2020-02-09 19:17:43","ADY":210,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.66804,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":244,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.66804,"AVALU":"YEARS","ADTM":"2021-02-19 06:28:08","ADY":244,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06078,"AVALU":"YEARS","ADTM":"2020-07-13 06:28:08","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.09202,"AVALU":"YEARS","ADTM":"2020-07-24 06:28:08","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":59.71429,"AVALU":"WEEKS","ADTM":"2021-08-11 15:07:22","ADY":418,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-1-id-93","SUBJID":"id-93","SITEID":"BRA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"Y","INVID":"INV ID BRA-1","INVNAM":"Dr. BRA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.86835,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-17","TRTSDTM":"2020-06-20 06:28:08","TRTEDTM":"2021-02-18 14:22:49","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":244,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-06-20 06:28:08","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.18532,"AVALU":"YEARS","ADTM":"2020-02-09 03:04:47","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23375,"AVALU":"YEARS","ADTM":"2020-02-27 03:04:47","ADY":86,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-03 03:04:47","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":60.71429,"AVALU":"WEEKS","ADTM":"2021-01-30 12:30:52","ADY":425,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-171","SUBJID":"id-171","SITEID":"BRA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":7.7018,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-01","TRTSDTM":"2019-12-03 03:04:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":42.14286,"AVALU":"WEEKS","ADTM":"2020-09-22 02:13:47","ADY":295,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.79591,"AVALU":"YEARS","ADTM":"2020-07-15 12:56:58","ADY":291,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10577,"AVALU":"YEARS","ADTM":"2019-11-06 12:56:58","ADY":39,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-28 12:56:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":82.42857,"AVALU":"WEEKS","ADTM":"2021-04-26 16:22:21","ADY":577,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-217","SUBJID":"id-217","SITEID":"BRA-11","AGE":43,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":0.4056,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-25","TRTSDTM":"2019-09-28 12:56:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":39,"AVALU":"WEEKS","ADTM":"2020-06-26 19:53:01","ADY":273,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.93087,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":340,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.93087,"AVALU":"YEARS","ADTM":"2021-02-13 15:35:44","ADY":340,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.93087,"AVALU":"YEARS","ADTM":"2021-02-13 15:35:44","ADY":340,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07932,"AVALU":"YEARS","ADTM":"2020-04-08 15:35:44","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-03-10 15:35:44","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-237","SUBJID":"id-237","SITEID":"BRA-11","AGE":64,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.29531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-10","TRTSDTM":"2020-03-10 15:35:44","TRTEDTM":"2021-02-12 06:55:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":79.71429,"AVALU":"WEEKS","ADTM":"2021-09-18 20:23:34","ADY":558,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-06 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-07 11:10:17","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03101,"AVALU":"YEARS","ADTM":"2020-10-18 11:10:17","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.37067,"AVALU":"YEARS","ADTM":"2021-02-19 11:10:17","ADY":136,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":67,"AVALU":"WEEKS","ADTM":"2022-01-17 10:38:17","ADY":469,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-321","SUBJID":"id-321","SITEID":"BRA-11","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":1.77524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-06","TRTSDTM":"2020-10-06 11:10:17","TRTEDTM":"2022-10-06 22:48:41","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":79.14286,"AVALU":"WEEKS","ADTM":"2022-04-12 22:45:38","ADY":554,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-18 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.0949,"AVALU":"YEARS","ADTM":"2020-09-22 04:34:59","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.62116,"AVALU":"YEARS","ADTM":"2021-04-02 04:34:59","ADY":227,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18474,"AVALU":"YEARS","ADTM":"2020-10-25 04:34:59","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.28571,"AVALU":"WEEKS","ADTM":"2020-09-09 10:26:24","ADY":23,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-345","SUBJID":"id-345","SITEID":"BRA-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.45154,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-15","TRTSDTM":"2020-08-18 04:34:59","TRTEDTM":"2022-08-18 16:13:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":92.28571,"AVALU":"WEEKS","ADTM":"2022-05-25 17:18:21","ADY":646,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-28 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.43603,"AVALU":"YEARS","ADTM":"2020-12-04 21:40:01","ADY":160,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-29 21:40:01","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-29 21:40:01","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":12.28571,"AVALU":"WEEKS","ADTM":"2020-09-20 04:01:25","ADY":86,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-397","SUBJID":"id-397","SITEID":"BRA-11","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":11.66389,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-06-23","TRTSDTM":"2020-06-27 21:40:01","TRTEDTM":"2022-06-28 09:18:25","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":54.85714,"AVALU":"WEEKS","ADTM":"2021-07-15 03:35:45","ADY":384,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-28 04:47:16","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-28 04:47:16","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11443,"AVALU":"YEARS","ADTM":"2019-06-09 04:47:16","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":29,"AVALU":"WEEKS","ADTM":"2019-11-16 15:05:51","ADY":203,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-50","SUBJID":"id-50","SITEID":"BRA-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.60612,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 04:47:16","TRTEDTM":"2021-04-27 16:25:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-10","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.28571,"AVALU":"WEEKS","ADTM":"2020-11-23 05:57:17","ADY":576,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-25 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-26 23:39:59","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.3444,"AVALU":"YEARS","ADTM":"2019-07-29 23:39:59","ADY":126,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1633,"AVALU":"YEARS","ADTM":"2019-05-24 23:39:59","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-03-25 23:39:59","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-11-id-9","SUBJID":"id-9","SITEID":"BRA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-11","INVNAM":"Dr. BRA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":7.0163,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-24","TRTSDTM":"2019-03-25 23:39:59","TRTEDTM":"2021-03-25 11:18:23","EOSSTT":"COMPLETED","EOSDT":"2021-03-25","EOSDY":731,"LSTALVDT":"2021-04-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-03-25 23:39:59","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.15632,"AVALU":"YEARS","ADTM":"2020-01-22 23:33:58","ADY":58,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-25 23:33:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-25 23:33:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":10.71429,"AVALU":"WEEKS","ADTM":"2020-02-07 10:51:42","ADY":75,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-12-id-59","SUBJID":"id-59","SITEID":"BRA-12","AGE":36,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-12","INVNAM":"Dr. BRA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":11.1938,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-23","TRTSDTM":"2019-11-25 23:33:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":93.57143,"AVALU":"WEEKS","ADTM":"2021-09-09 01:43:51","ADY":655,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-30 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1125,"AVALU":"YEARS","ADTM":"2020-10-11 08:29:18","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08247,"AVALU":"YEARS","ADTM":"2020-09-30 08:29:18","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-31 08:29:18","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":29.42857,"AVALU":"WEEKS","ADTM":"2021-03-23 05:39:21","ADY":206,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-13-id-177","SUBJID":"id-177","SITEID":"BRA-13","AGE":24,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-13","INVNAM":"Dr. BRA-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":12.71923,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-27","TRTSDTM":"2020-08-30 08:29:18","TRTEDTM":"2022-08-30 20:07:42","EOSSTT":"COMPLETED","EOSDT":"2022-08-30","EOSDY":731,"LSTALVDT":"2022-09-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":31.85714,"AVALU":"WEEKS","ADTM":"2021-04-09 20:53:58","ADY":223,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-20 08:50:48","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-20 08:50:48","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1627,"AVALU":"YEARS","ADTM":"2020-11-18 08:50:48","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46,"AVALU":"WEEKS","ADTM":"2021-08-06 04:10:57","ADY":322,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-120","SUBJID":"id-120","SITEID":"BRA-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.93474,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-17","TRTSDTM":"2020-09-19 08:50:48","TRTEDTM":"2022-09-19 20:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-09-19","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":99.28571,"AVALU":"WEEKS","ADTM":"2022-08-14 10:14:04","ADY":695,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-06 10:26:03","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-06 10:26:03","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00333,"AVALU":"YEARS","ADTM":"2019-11-08 10:26:03","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.57143,"AVALU":"WEEKS","ADTM":"2019-11-30 18:48:14","ADY":25,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-14-id-23","SUBJID":"id-23","SITEID":"BRA-14","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-14","INVNAM":"Dr. BRA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.20239,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-03","TRTSDTM":"2019-11-06 10:26:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":4.85714,"AVALU":"WEEKS","ADTM":"2019-12-09 01:35:56","ADY":34,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-07 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-08 02:36:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08997,"AVALU":"YEARS","ADTM":"2020-02-10 02:36:05","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05329,"AVALU":"YEARS","ADTM":"2020-01-28 02:36:05","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":93.71429,"AVALU":"WEEKS","ADTM":"2021-10-24 00:11:43","ADY":656,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-15-id-36","SUBJID":"id-36","SITEID":"BRA-15","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-15","INVNAM":"Dr. BRA-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.40685,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 02:36:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":17.85714,"AVALU":"WEEKS","ADTM":"2020-05-11 08:31:40","ADY":125,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-06-26 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.31432,"AVALU":"YEARS","ADTM":"2020-10-19 00:09:56","ADY":115,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-06-27 00:09:56","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.57527,"AVALU":"YEARS","ADTM":"2021-01-23 00:09:56","ADY":211,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":91.42857,"AVALU":"WEEKS","ADTM":"2022-03-27 17:49:42","ADY":640,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-101","SUBJID":"id-101","SITEID":"BRA-2","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.18055,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-26 00:09:56","TRTEDTM":"2022-06-26 11:48:20","EOSSTT":"COMPLETED","EOSDT":"2022-06-26","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":102.85714,"AVALU":"WEEKS","ADTM":"2022-06-15 12:11:00","ADY":720,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.07666,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":28,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00652,"AVALU":"YEARS","ADTM":"2021-01-25 01:57:55","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07666,"AVALU":"YEARS","ADTM":"2021-02-19 01:57:55","ADY":28,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01331,"AVALU":"YEARS","ADTM":"2021-01-27 01:57:55","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":37.14286,"AVALU":"WEEKS","ADTM":"2021-10-08 09:59:53","ADY":260,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-2-id-296","SUBJID":"id-296","SITEID":"BRA-2","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-2","INVNAM":"Dr. BRA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.75083,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-19","TRTSDTM":"2021-01-22 01:57:55","TRTEDTM":"2021-02-18 05:48:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":28,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":88.28571,"AVALU":"WEEKS","ADTM":"2022-10-01 17:44:17","ADY":618,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-25 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04475,"AVALU":"YEARS","ADTM":"2020-05-11 22:37:16","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.30332,"AVALU":"YEARS","ADTM":"2020-08-13 22:37:16","ADY":111,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0768,"AVALU":"YEARS","ADTM":"2020-05-23 22:37:16","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":36.71429,"AVALU":"WEEKS","ADTM":"2021-01-05 23:08:45","ADY":257,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-13","SUBJID":"id-13","SITEID":"BRA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.88873,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-20","TRTSDTM":"2020-04-24 22:37:16","TRTEDTM":"2022-04-25 10:15:40","EOSSTT":"COMPLETED","EOSDT":"2022-04-25","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":100.85714,"AVALU":"WEEKS","ADTM":"2022-03-30 23:14:32","ADY":706,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-13 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07478,"AVALU":"YEARS","ADTM":"2020-04-09 23:29:33","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08476,"AVALU":"YEARS","ADTM":"2020-04-12 23:29:33","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.07116,"AVALU":"YEARS","ADTM":"2021-04-08 23:29:33","ADY":392,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-03-12 23:29:33","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-3-id-8","SUBJID":"id-8","SITEID":"BRA-3","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-3","INVNAM":"Dr. BRA-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":0.64837,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 23:29:33","TRTEDTM":"2022-03-13 11:07:57","EOSSTT":"COMPLETED","EOSDT":"2022-03-13","EOSDY":731,"LSTALVDT":"2022-04-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":56.28571,"AVALU":"WEEKS","ADTM":"2021-04-09 23:13:11","ADY":394,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-25 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-26 19:35:07","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08406,"AVALU":"YEARS","ADTM":"2020-03-27 19:35:07","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1395,"AVALU":"YEARS","ADTM":"2020-04-16 19:35:07","ADY":51,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42.14286,"AVALU":"WEEKS","ADTM":"2020-12-15 10:48:25","ADY":295,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-368","SUBJID":"id-368","SITEID":"BRA-4","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.20454,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-25","TRTSDTM":"2020-02-25 19:35:07","TRTEDTM":"2022-02-25 07:13:31","EOSSTT":"COMPLETED","EOSDT":"2022-02-25","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":13.85714,"AVALU":"WEEKS","ADTM":"2020-05-31 23:12:53","ADY":97,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11407,"AVALU":"YEARS","ADTM":"2020-02-29 21:34:39","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10738,"AVALU":"YEARS","ADTM":"2020-02-27 21:34:39","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.3818,"AVALU":"YEARS","ADTM":"2020-06-06 21:34:39","ADY":140,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":16.14286,"AVALU":"WEEKS","ADTM":"2020-05-09 11:02:50","ADY":113,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-4-id-383","SUBJID":"id-383","SITEID":"BRA-4","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-4","INVNAM":"Dr. BRA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":4.60353,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-15","TRTSDTM":"2020-01-18 21:34:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":36.57143,"AVALU":"WEEKS","ADTM":"2020-09-29 00:56:19","ADY":256,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-22 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-23 20:43:51","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.17766,"AVALU":"YEARS","ADTM":"2019-08-26 20:43:51","ADY":65,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14424,"AVALU":"YEARS","ADTM":"2019-08-14 20:43:51","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":16.71429,"AVALU":"WEEKS","ADTM":"2019-10-16 14:56:01","ADY":117,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-5-id-234","SUBJID":"id-234","SITEID":"BRA-5","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-5","INVNAM":"Dr. BRA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.86786,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-21","TRTSDTM":"2019-06-22 20:43:51","TRTEDTM":"2021-06-22 08:22:15","EOSSTT":"COMPLETED","EOSDT":"2021-06-22","EOSDY":731,"LSTALVDT":"2021-07-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":64.28571,"AVALU":"WEEKS","ADTM":"2020-09-13 12:57:09","ADY":450,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-13 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10568,"AVALU":"YEARS","ADTM":"2020-09-21 10:11:04","ADY":39,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.39559,"AVALU":"YEARS","ADTM":"2021-01-05 10:11:04","ADY":145,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-14 10:11:04","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-08-13 10:11:04","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-6-id-369","SUBJID":"id-369","SITEID":"BRA-6","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-6","INVNAM":"Dr. BRA-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"South America","STRATA1":"A","STRATA2":"S1","BMRKR1":5.41359,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-09","TRTSDTM":"2020-08-13 10:11:04","TRTEDTM":"2022-08-13 21:49:28","EOSSTT":"COMPLETED","EOSDT":"2022-08-13","EOSDY":731,"LSTALVDT":"2022-08-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":32.57143,"AVALU":"WEEKS","ADTM":"2021-03-28 10:35:40","ADY":228,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-25 03:27:39","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09033,"AVALU":"YEARS","ADTM":"2019-08-27 03:27:39","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06733,"AVALU":"YEARS","ADTM":"2019-08-19 03:27:39","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":93.42857,"AVALU":"WEEKS","ADTM":"2021-05-08 05:39:40","ADY":654,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-BRA-7-id-301","SUBJID":"id-301","SITEID":"BRA-7","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"BRA","DTHFL":"N","INVID":"INV ID BRA-7","INVNAM":"Dr. BRA-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"South America","STRATA1":"B","STRATA2":"S2","BMRKR1":10.52061,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-21","TRTSDTM":"2019-07-25 03:27:39","TRTEDTM":"2021-07-24 15:06:03","EOSSTT":"COMPLETED","EOSDT":"2021-07-24","EOSDY":731,"LSTALVDT":"2021-08-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":10.71429,"AVALU":"WEEKS","ADTM":"2019-10-07 09:02:30","ADY":75,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.20839,"AVALU":"YEARS","ADTM":"2021-03-20 01:41:06","ADY":77,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.14457,"AVALU":"YEARS","ADTM":"2021-02-24 01:41:06","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0858,"AVALU":"YEARS","ADTM":"2021-02-03 01:41:06","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2021-01-02 01:41:06","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-18","SUBJID":"id-18","SITEID":"CAN-1","AGE":41,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":7.47872,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-30","TRTSDTM":"2021-01-02 01:41:06","TRTEDTM":"2023-01-02 13:19:30","EOSSTT":"COMPLETED","EOSDT":"2023-01-02","EOSDY":731,"LSTALVDT":"2023-01-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":48.14286,"AVALU":"WEEKS","ADTM":"2021-12-04 20:48:44","ADY":337,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.74127,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":636,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.23879,"AVALU":"YEARS","ADTM":"2019-08-19 08:21:19","ADY":88,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.35514,"AVALU":"YEARS","ADTM":"2020-09-29 08:21:19","ADY":495,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.42443,"AVALU":"YEARS","ADTM":"2019-10-26 08:21:19","ADY":156,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-05-23 08:21:19","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-1-id-341","SUBJID":"id-341","SITEID":"CAN-1","AGE":43,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-1","INVNAM":"Dr. CAN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":4.64258,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-20","TRTSDTM":"2019-05-23 08:21:19","TRTEDTM":"2021-02-16 10:41:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":636,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":55.71429,"AVALU":"WEEKS","ADTM":"2020-06-15 04:04:30","ADY":390,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.6071,"AVALU":"YEARS","ADTM":"2021-04-25 01:00:05","ADY":222,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-16 01:00:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20763,"AVALU":"YEARS","ADTM":"2020-11-30 01:00:05","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.71429,"AVALU":"WEEKS","ADTM":"2021-08-07 18:48:31","ADY":327,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-139","SUBJID":"id-139","SITEID":"CAN-11","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":15.07391,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-14","TRTSDTM":"2020-09-15 01:00:05","TRTEDTM":"2022-09-15 12:38:29","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":68.85714,"AVALU":"WEEKS","ADTM":"2022-01-09 04:11:58","ADY":482,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-09 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05196,"AVALU":"YEARS","ADTM":"2020-06-27 23:41:28","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03571,"AVALU":"YEARS","ADTM":"2020-06-22 23:41:28","ADY":14,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01697,"AVALU":"YEARS","ADTM":"2020-06-15 23:41:28","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":8.71429,"AVALU":"WEEKS","ADTM":"2020-08-07 05:43:12","ADY":61,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-11-id-306","SUBJID":"id-306","SITEID":"CAN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-11","INVNAM":"Dr. CAN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":3.11267,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-04","TRTSDTM":"2020-06-08 23:41:28","TRTEDTM":"2022-06-09 11:19:52","EOSSTT":"COMPLETED","EOSDT":"2022-06-09","EOSDY":731,"LSTALVDT":"2022-06-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":1,"AVALU":"WEEKS","ADTM":"2020-06-14 22:32:01","ADY":7,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.64819,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":602,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.64819,"AVALU":"YEARS","ADTM":"2021-02-19 02:48:11","ADY":602,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.64819,"AVALU":"YEARS","ADTM":"2021-02-19 02:48:11","ADY":602,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.43472,"AVALU":"YEARS","ADTM":"2019-12-04 02:48:11","ADY":159,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-06-28 02:48:11","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-14-id-104","SUBJID":"id-104","SITEID":"CAN-14","AGE":39,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CAN","DTHFL":"Y","INVID":"INV ID CAN-14","INVNAM":"Dr. CAN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.66313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-26","TRTSDTM":"2019-06-28 02:48:11","TRTEDTM":"2021-02-18 23:39:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":602,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.57143,"AVALU":"WEEKS","ADTM":"2020-06-22 09:59:54","ADY":361,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06888,"AVALU":"YEARS","ADTM":"2020-12-13 07:46:27","ADY":26,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01272,"AVALU":"YEARS","ADTM":"2020-11-22 07:46:27","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08994,"AVALU":"YEARS","ADTM":"2020-12-20 07:46:27","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":93.42857,"AVALU":"WEEKS","ADTM":"2022-09-01 02:45:15","ADY":654,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-324","SUBJID":"id-324","SITEID":"CAN-4","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.34637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 07:46:27","TRTEDTM":"2022-11-17 19:24:51","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-11-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":17.71429,"AVALU":"WEEKS","ADTM":"2021-03-20 05:41:57","ADY":124,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-03 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.37651,"AVALU":"YEARS","ADTM":"2020-09-18 04:46:51","ADY":138,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.05539,"AVALU":"YEARS","ADTM":"2020-05-24 04:46:51","ADY":21,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00476,"AVALU":"YEARS","ADTM":"2020-05-05 04:46:51","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-05-03 04:46:51","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-4-id-331","SUBJID":"id-331","SITEID":"CAN-4","AGE":34,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-4","INVNAM":"Dr. CAN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":3.65637,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:46:51","TRTEDTM":"2022-05-03 16:25:15","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":66.57143,"AVALU":"WEEKS","ADTM":"2021-08-11 02:17:25","ADY":466,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-14 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.25572,"AVALU":"YEARS","ADTM":"2020-01-17 06:59:19","ADY":94,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.32605,"AVALU":"YEARS","ADTM":"2020-02-12 06:59:19","ADY":120,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-15 06:59:19","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":95.42857,"AVALU":"WEEKS","ADTM":"2021-08-12 18:15:41","ADY":668,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CAN-5-id-121","SUBJID":"id-121","SITEID":"CAN-5","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CAN","DTHFL":"N","INVID":"INV ID CAN-5","INVNAM":"Dr. CAN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":8.41726,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-11","TRTSDTM":"2019-10-15 06:59:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-10-15 06:59:19","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-31 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10645,"AVALU":"YEARS","ADTM":"2020-09-08 01:35:32","ADY":39,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18386,"AVALU":"YEARS","ADTM":"2020-10-07 01:35:32","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.56563,"AVALU":"YEARS","ADTM":"2021-02-23 01:35:32","ADY":207,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":47.71429,"AVALU":"WEEKS","ADTM":"2021-06-29 08:07:20","ADY":334,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-107","SUBJID":"id-107","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.02114,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-07-31 01:35:32","TRTEDTM":"2022-07-31 13:13:56","EOSSTT":"COMPLETED","EOSDT":"2022-07-31","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":16.42857,"AVALU":"WEEKS","ADTM":"2020-11-22 04:18:36","ADY":115,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-13 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-14 00:49:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03106,"AVALU":"YEARS","ADTM":"2020-01-26 00:49:05","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05443,"AVALU":"YEARS","ADTM":"2020-02-03 00:49:05","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":58.85714,"AVALU":"WEEKS","ADTM":"2021-02-28 04:30:18","ADY":412,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-119","SUBJID":"id-119","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":8.61739,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-14 00:49:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":7.85714,"AVALU":"WEEKS","ADTM":"2020-03-08 14:20:56","ADY":55,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.09156,"AVALU":"YEARS","ADTM":"2021-01-23 05:25:16","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01575,"AVALU":"YEARS","ADTM":"2020-12-26 05:25:16","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03145,"AVALU":"YEARS","ADTM":"2021-01-01 05:25:16","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":75.42857,"AVALU":"WEEKS","ADTM":"2022-05-31 16:11:09","ADY":528,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-12","SUBJID":"id-12","SITEID":"CHN-1","AGE":42,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.24721,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-20 05:25:16","TRTEDTM":"2022-12-20 17:03:40","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":103.57143,"AVALU":"WEEKS","ADTM":"2022-12-14 23:19:13","ADY":725,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.15654,"AVALU":"YEARS","ADTM":"2020-03-26 17:16:09","ADY":58,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-28 17:16:09","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0931,"AVALU":"YEARS","ADTM":"2020-03-03 17:16:09","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":99.85714,"AVALU":"WEEKS","ADTM":"2021-12-26 11:17:49","ADY":699,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-123","SUBJID":"id-123","SITEID":"CHN-1","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.88609,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-24","TRTSDTM":"2020-01-28 17:16:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.57143,"AVALU":"WEEKS","ADTM":"2020-06-05 03:22:36","ADY":130,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-08 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00062,"AVALU":"YEARS","ADTM":"2020-08-09 02:54:25","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-09 02:54:25","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-09 02:54:25","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":36.42857,"AVALU":"WEEKS","ADTM":"2021-04-19 09:54:32","ADY":255,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-133","SUBJID":"id-133","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.31712,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-08 02:54:25","TRTEDTM":"2022-08-08 14:32:49","EOSSTT":"COMPLETED","EOSDT":"2022-08-08","EOSDY":731,"LSTALVDT":"2022-08-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":103.14286,"AVALU":"WEEKS","ADTM":"2022-07-30 17:16:39","ADY":722,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-19 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-20 20:19:02","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.12663,"AVALU":"YEARS","ADTM":"2020-04-06 20:19:02","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-20 20:19:02","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":62.28571,"AVALU":"WEEKS","ADTM":"2021-04-29 21:37:44","ADY":436,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-144","SUBJID":"id-144","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.10856,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-16","TRTSDTM":"2020-02-19 20:19:02","TRTEDTM":"2022-02-19 07:57:26","EOSSTT":"COMPLETED","EOSDT":"2022-02-19","EOSDY":731,"LSTALVDT":"2022-03-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":6.57143,"AVALU":"WEEKS","ADTM":"2020-04-04 20:25:53","ADY":46,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.45448,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":166,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.45448,"AVALU":"YEARS","ADTM":"2021-02-19 10:54:39","ADY":166,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.40107,"AVALU":"YEARS","ADTM":"2021-01-31 10:54:39","ADY":147,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14539,"AVALU":"YEARS","ADTM":"2020-10-30 10:54:39","ADY":54,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":93.42857,"AVALU":"WEEKS","ADTM":"2022-06-21 02:15:36","ADY":654,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-156","SUBJID":"id-156","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.72875,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-05","TRTSDTM":"2020-09-06 10:54:39","TRTEDTM":"2021-02-18 09:16:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":165,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":91,"AVALU":"WEEKS","ADTM":"2022-06-04 07:23:35","ADY":637,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-04 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-05 15:11:05","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.1068,"AVALU":"YEARS","ADTM":"2021-02-12 15:11:05","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-05 15:11:05","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":100.85714,"AVALU":"WEEKS","ADTM":"2022-12-09 12:38:06","ADY":706,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-16","SUBJID":"id-16","SITEID":"CHN-1","AGE":46,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.92419,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-02","TRTSDTM":"2021-01-03 15:11:05","TRTEDTM":"2023-01-04 02:49:29","EOSSTT":"COMPLETED","EOSDT":"2023-01-04","EOSDY":731,"LSTALVDT":"2023-01-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.28571,"AVALU":"WEEKS","ADTM":"2021-01-04 01:47:45","ADY":2,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.72827,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":266,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.72827,"AVALU":"YEARS","ADTM":"2021-02-17 03:32:35","ADY":266,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02054,"AVALU":"YEARS","ADTM":"2020-06-04 03:32:35","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.72827,"AVALU":"YEARS","ADTM":"2021-02-17 03:32:35","ADY":266,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":98,"AVALU":"WEEKS","ADTM":"2022-04-12 17:02:09","ADY":686,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-163","SUBJID":"id-163","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.76362,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-27","TRTSDTM":"2020-05-27 03:32:35","TRTEDTM":"2021-02-16 03:22:08","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":265,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.71429,"AVALU":"WEEKS","ADTM":"2021-12-26 19:48:59","ADY":579,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08967,"AVALU":"YEARS","ADTM":"2020-06-07 04:02:17","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-06 04:02:17","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.21584,"AVALU":"YEARS","ADTM":"2020-07-23 04:02:17","ADY":79,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":31.42857,"AVALU":"WEEKS","ADTM":"2020-12-10 04:33:01","ADY":220,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-181","SUBJID":"id-181","SITEID":"CHN-1","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.5313,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-03","TRTSDTM":"2020-05-05 04:02:17","TRTEDTM":"2022-05-05 15:40:41","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-06-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.57143,"AVALU":"WEEKS","ADTM":"2021-04-30 03:21:48","ADY":361,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-02-03 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.02453,"AVALU":"YEARS","ADTM":"2021-02-11 19:14:46","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20697,"AVALU":"YEARS","ADTM":"2021-04-19 19:14:46","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14203,"AVALU":"YEARS","ADTM":"2021-03-26 19:14:46","ADY":52,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.42857,"AVALU":"WEEKS","ADTM":"2021-03-11 20:16:34","ADY":38,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-186","SUBJID":"id-186","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.52118,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 19:14:46","TRTEDTM":"2023-02-03 06:53:10","EOSSTT":"COMPLETED","EOSDT":"2023-02-03","EOSDY":731,"LSTALVDT":"2023-03-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":7.42857,"AVALU":"WEEKS","ADTM":"2021-03-25 06:09:36","ADY":52,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-06-01 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.65789,"AVALU":"YEARS","ADTM":"2021-01-28 06:49:09","ADY":241,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06179,"AVALU":"YEARS","ADTM":"2020-06-24 06:49:09","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02451,"AVALU":"YEARS","ADTM":"2020-06-10 06:49:09","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.71429,"AVALU":"WEEKS","ADTM":"2020-10-02 00:29:24","ADY":124,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-197","SUBJID":"id-197","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.65225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-29","TRTSDTM":"2020-06-01 06:49:09","TRTEDTM":"2022-06-01 18:27:33","EOSSTT":"COMPLETED","EOSDT":"2022-06-01","EOSDY":731,"LSTALVDT":"2022-06-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":85.71429,"AVALU":"WEEKS","ADTM":"2022-01-21 06:39:12","ADY":600,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.11157,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":406,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.20983,"AVALU":"YEARS","ADTM":"2020-03-25 21:37:54","ADY":77,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0493,"AVALU":"YEARS","ADTM":"2020-01-27 21:37:54","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14725,"AVALU":"YEARS","ADTM":"2020-03-02 21:37:54","ADY":54,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":58.85714,"AVALU":"WEEKS","ADTM":"2021-02-22 16:25:45","ADY":412,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-199","SUBJID":"id-199","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.85826,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-07","TRTSDTM":"2020-01-08 21:37:54","TRTEDTM":"2021-02-16 04:54:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":405,"DCSREAS":"DEATH","DTHDT":"2021-02-26","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-01-08 21:37:54","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.53936,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":197,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.03442,"AVALU":"YEARS","ADTM":"2020-08-13 14:59:28","ADY":13,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.53936,"AVALU":"YEARS","ADTM":"2021-02-13 14:59:28","ADY":197,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12266,"AVALU":"YEARS","ADTM":"2020-09-14 14:59:28","ADY":45,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":82.28571,"AVALU":"WEEKS","ADTM":"2022-02-26 07:54:05","ADY":576,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-208","SUBJID":"id-208","SITEID":"CHN-1","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.5165,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-27","TRTSDTM":"2020-07-31 14:59:28","TRTEDTM":"2021-02-12 06:55:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":196,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-07-31 14:59:28","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.1232,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":45,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1232,"AVALU":"YEARS","ADTM":"2021-02-13 06:20:31","ADY":45,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.04503,"AVALU":"YEARS","ADTM":"2021-01-16 06:20:31","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00308,"AVALU":"YEARS","ADTM":"2021-01-01 06:20:31","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":41.57143,"AVALU":"WEEKS","ADTM":"2021-10-16 05:25:24","ADY":291,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-212","SUBJID":"id-212","SITEID":"CHN-1","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.12569,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-28","TRTSDTM":"2020-12-30 06:20:31","TRTEDTM":"2021-02-12 17:43:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":45,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":50.57143,"AVALU":"WEEKS","ADTM":"2021-12-18 19:25:14","ADY":354,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.36413,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":133,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.36184,"AVALU":"YEARS","ADTM":"2021-02-14 02:33:45","ADY":133,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01421,"AVALU":"YEARS","ADTM":"2020-10-10 02:33:45","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.36413,"AVALU":"YEARS","ADTM":"2021-02-14 02:33:45","ADY":133,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5,"AVALU":"WEEKS","ADTM":"2020-11-07 02:37:06","ADY":35,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-216","SUBJID":"id-216","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.43058,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-30","TRTSDTM":"2020-10-04 02:33:45","TRTEDTM":"2021-02-13 07:10:17","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":133,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":29.85714,"AVALU":"WEEKS","ADTM":"2021-04-30 22:03:07","ADY":209,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-09 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.2816,"AVALU":"YEARS","ADTM":"2019-07-21 23:07:57","ADY":103,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.52076,"AVALU":"YEARS","ADTM":"2019-10-17 23:07:57","ADY":191,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01533,"AVALU":"YEARS","ADTM":"2019-04-15 23:07:57","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.71429,"AVALU":"WEEKS","ADTM":"2019-05-18 05:56:15","ADY":40,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-227","SUBJID":"id-227","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.1904,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-07","TRTSDTM":"2019-04-09 23:07:57","TRTEDTM":"2021-04-09 10:46:21","EOSSTT":"COMPLETED","EOSDT":"2021-04-09","EOSDY":731,"LSTALVDT":"2021-04-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":78.28571,"AVALU":"WEEKS","ADTM":"2020-10-07 09:05:18","ADY":548,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-13 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.25159,"AVALU":"YEARS","ADTM":"2021-01-13 11:45:54","ADY":92,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.04812,"AVALU":"YEARS","ADTM":"2020-10-31 11:45:54","ADY":18,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01382,"AVALU":"YEARS","ADTM":"2020-10-19 11:45:54","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-10-13 11:45:54","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-229","SUBJID":"id-229","SITEID":"CHN-1","AGE":37,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":9.50695,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 11:45:54","TRTEDTM":"2022-10-13 23:24:18","EOSSTT":"COMPLETED","EOSDT":"2022-10-13","EOSDY":731,"LSTALVDT":"2022-10-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":84.71429,"AVALU":"WEEKS","ADTM":"2022-05-28 17:47:14","ADY":593,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-24 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.31733,"AVALU":"YEARS","ADTM":"2020-06-19 14:24:08","ADY":116,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.12886,"AVALU":"YEARS","ADTM":"2020-04-12 14:24:08","ADY":48,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.27062,"AVALU":"YEARS","ADTM":"2020-06-02 14:24:08","ADY":99,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":54.85714,"AVALU":"WEEKS","ADTM":"2021-03-13 21:17:13","ADY":384,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-232","SUBJID":"id-232","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.17424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-24 14:24:08","TRTEDTM":"2022-02-24 02:02:32","EOSSTT":"COMPLETED","EOSDT":"2022-02-24","EOSDY":731,"LSTALVDT":"2022-03-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-02-24 14:24:08","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.01916,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":7,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01916,"AVALU":"YEARS","ADTM":"2021-02-18 21:33:08","ADY":7,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01916,"AVALU":"YEARS","ADTM":"2021-02-18 21:33:08","ADY":7,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00888,"AVALU":"YEARS","ADTM":"2021-02-15 21:33:08","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":27.42857,"AVALU":"WEEKS","ADTM":"2021-08-21 06:50:30","ADY":192,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-233","SUBJID":"id-233","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.07682,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-09","TRTSDTM":"2021-02-11 21:33:08","TRTEDTM":"2021-02-17 09:12:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":6,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":25.57143,"AVALU":"WEEKS","ADTM":"2021-08-08 06:16:00","ADY":179,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.59617,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":583,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.59617,"AVALU":"YEARS","ADTM":"2021-02-15 00:33:07","ADY":583,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07986,"AVALU":"YEARS","ADTM":"2019-08-12 00:33:07","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.59617,"AVALU":"YEARS","ADTM":"2021-02-15 00:33:07","ADY":583,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":104,"AVALU":"WEEKS","ADTM":"2021-07-09 20:26:06","ADY":728,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-235","SUBJID":"id-235","SITEID":"CHN-1","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.71119,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-13 00:33:07","TRTEDTM":"2021-02-14 04:43:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":583,"DCSREAS":"DEATH","DTHDT":"2021-02-16","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":2,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":44.28571,"AVALU":"WEEKS","ADTM":"2020-05-17 11:31:03","ADY":310,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-03 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11083,"AVALU":"YEARS","ADTM":"2020-12-13 12:32:46","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11993,"AVALU":"YEARS","ADTM":"2020-12-16 12:32:46","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03199,"AVALU":"YEARS","ADTM":"2020-11-14 12:32:46","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":37,"AVALU":"WEEKS","ADTM":"2021-07-18 19:59:05","ADY":259,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-25","SUBJID":"id-25","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.7821,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-29","TRTSDTM":"2020-11-02 12:32:46","TRTEDTM":"2022-11-03 00:11:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-03","EOSDY":731,"LSTALVDT":"2022-11-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":70.71429,"AVALU":"WEEKS","ADTM":"2022-03-11 03:44:22","ADY":495,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-25 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-26 11:48:09","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03469,"AVALU":"YEARS","ADTM":"2020-11-07 11:48:09","ADY":13,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03097,"AVALU":"YEARS","ADTM":"2020-11-06 11:48:09","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":82.14286,"AVALU":"WEEKS","ADTM":"2022-05-22 21:12:34","ADY":575,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-253","SUBJID":"id-253","SITEID":"CHN-1","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.93549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-25 11:48:09","TRTEDTM":"2022-10-25 23:26:33","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":101.14286,"AVALU":"WEEKS","ADTM":"2022-10-02 03:18:09","ADY":708,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07382,"AVALU":"YEARS","ADTM":"2020-08-12 12:12:15","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.12221,"AVALU":"YEARS","ADTM":"2020-08-30 12:12:15","ADY":45,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.13637,"AVALU":"YEARS","ADTM":"2020-09-04 12:12:15","ADY":50,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":96.42857,"AVALU":"WEEKS","ADTM":"2022-05-21 06:27:24","ADY":675,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-26","SUBJID":"id-26","SITEID":"CHN-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.07407,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-12","TRTSDTM":"2020-07-16 12:12:15","TRTEDTM":"2022-07-16 23:50:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-16","EOSDY":731,"LSTALVDT":"2022-08-10","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60,"AVALU":"WEEKS","ADTM":"2021-09-08 00:28:04","ADY":420,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-03 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.0016,"AVALU":"YEARS","ADTM":"2020-06-03 23:14:53","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.12061,"AVALU":"YEARS","ADTM":"2020-07-17 23:14:53","ADY":45,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-04 23:14:53","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":19.85714,"AVALU":"WEEKS","ADTM":"2020-10-18 22:52:45","ADY":139,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-275","SUBJID":"id-275","SITEID":"CHN-1","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.14151,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-01","TRTSDTM":"2020-06-02 23:14:53","TRTEDTM":"2022-06-03 10:53:17","EOSSTT":"COMPLETED","EOSDT":"2022-06-03","EOSDY":731,"LSTALVDT":"2022-06-18","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72,"AVALU":"WEEKS","ADTM":"2021-10-18 06:38:16","ADY":504,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08369,"AVALU":"YEARS","ADTM":"2020-11-24 04:59:36","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.21138,"AVALU":"YEARS","ADTM":"2021-01-10 04:59:36","ADY":78,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.15642,"AVALU":"YEARS","ADTM":"2020-12-21 04:59:36","ADY":58,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.14286,"AVALU":"WEEKS","ADTM":"2020-11-14 18:22:36","ADY":22,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-276","SUBJID":"id-276","SITEID":"CHN-1","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.68599,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 04:59:36","TRTEDTM":"2022-10-24 16:38:00","EOSSTT":"COMPLETED","EOSDT":"2022-10-24","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":58,"AVALU":"WEEKS","ADTM":"2021-12-03 01:10:22","ADY":406,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.09035,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":33,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.09035,"AVALU":"YEARS","ADTM":"2021-02-16 16:43:16","ADY":33,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07701,"AVALU":"YEARS","ADTM":"2021-02-12 16:43:16","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02541,"AVALU":"YEARS","ADTM":"2021-01-24 16:43:16","ADY":10,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2021-01-14 16:43:16","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-277","SUBJID":"id-277","SITEID":"CHN-1","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.07227,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 16:43:16","TRTEDTM":"2021-02-15 16:03:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":32,"DCSREAS":"DEATH","DTHDT":"2021-03-11","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":24,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.42857,"AVALU":"WEEKS","ADTM":"2021-07-17 13:38:14","ADY":185,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.9117,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":333,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.9117,"AVALU":"YEARS","ADTM":"2021-02-13 18:07:02","ADY":333,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.00279,"AVALU":"YEARS","ADTM":"2020-03-19 18:07:02","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.9117,"AVALU":"YEARS","ADTM":"2021-02-13 18:07:02","ADY":333,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":66,"AVALU":"WEEKS","ADTM":"2021-06-21 19:44:13","ADY":462,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-279","SUBJID":"id-279","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.64194,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-16","TRTSDTM":"2020-03-17 18:07:02","TRTEDTM":"2021-02-12 19:22:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":333,"DCSREAS":"DEATH","DTHDT":"2021-02-18","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-18","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":7.57143,"AVALU":"WEEKS","ADTM":"2020-05-08 13:40:41","ADY":53,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.24572,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":455,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.28797,"AVALU":"YEARS","ADTM":"2020-03-08 12:37:49","ADY":106,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.24572,"AVALU":"YEARS","ADTM":"2021-02-21 12:37:49","ADY":456,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.39214,"AVALU":"YEARS","ADTM":"2020-04-15 12:37:49","ADY":144,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":10.85714,"AVALU":"WEEKS","ADTM":"2020-02-06 21:29:15","ADY":76,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-287","SUBJID":"id-287","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.19352,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-19","TRTSDTM":"2019-11-23 12:37:49","TRTEDTM":"2021-02-19 20:10:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":455,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.57143,"AVALU":"WEEKS","ADTM":"2020-01-21 09:08:44","ADY":60,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.1937,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":436,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.46704,"AVALU":"YEARS","ADTM":"2020-05-30 09:08:22","ADY":171,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.42607,"AVALU":"YEARS","ADTM":"2020-05-15 09:08:22","ADY":156,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20996,"AVALU":"YEARS","ADTM":"2020-02-26 09:08:22","ADY":77,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.85714,"AVALU":"WEEKS","ADTM":"2020-01-20 01:30:28","ADY":41,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-288","SUBJID":"id-288","SITEID":"CHN-1","AGE":42,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.58264,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-09","TRTSDTM":"2019-12-11 09:08:22","TRTEDTM":"2021-02-18 18:36:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":436,"DCSREAS":"DEATH","DTHDT":"2021-03-09","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":19,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":59.57143,"AVALU":"WEEKS","ADTM":"2021-01-30 18:28:29","ADY":417,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-10 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.58093,"AVALU":"YEARS","ADTM":"2019-10-10 08:00:53","ADY":213,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.04871,"AVALU":"YEARS","ADTM":"2019-03-29 08:00:53","ADY":18,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12343,"AVALU":"YEARS","ADTM":"2019-04-26 08:00:53","ADY":46,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":49.42857,"AVALU":"WEEKS","ADTM":"2020-02-19 08:00:10","ADY":346,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-307","SUBJID":"id-307","SITEID":"CHN-1","AGE":24,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57499,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-08","TRTSDTM":"2019-03-11 08:00:53","TRTEDTM":"2021-03-10 19:39:17","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":13.57143,"AVALU":"WEEKS","ADTM":"2019-06-13 00:20:23","ADY":95,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-06 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-07 02:53:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-07 02:53:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01014,"AVALU":"YEARS","ADTM":"2020-02-11 02:53:58","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":13,"AVALU":"WEEKS","ADTM":"2020-05-07 08:38:12","ADY":91,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-312","SUBJID":"id-312","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.48925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-04","TRTSDTM":"2020-02-07 02:53:58","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.28571,"AVALU":"WEEKS","ADTM":"2021-01-30 05:04:27","ADY":359,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-08-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.211,"AVALU":"YEARS","ADTM":"2019-11-07 07:25:15","ADY":78,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10214,"AVALU":"YEARS","ADTM":"2019-09-28 07:25:15","ADY":38,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.66671,"AVALU":"YEARS","ADTM":"2020-04-21 07:25:15","ADY":244,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":18.57143,"AVALU":"WEEKS","ADTM":"2019-12-28 15:45:39","ADY":130,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-315","SUBJID":"id-315","SITEID":"CHN-1","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.43787,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-21","TRTSDTM":"2019-08-21 07:25:15","TRTEDTM":"2021-08-20 19:03:39","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":41.57143,"AVALU":"WEEKS","ADTM":"2020-06-06 05:55:22","ADY":291,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.64581,"AVALU":"YEARS","ADTM":"2021-05-09 09:48:45","ADY":236,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09668,"AVALU":"YEARS","ADTM":"2020-10-21 09:48:45","ADY":36,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.44276,"AVALU":"YEARS","ADTM":"2021-02-24 09:48:45","ADY":162,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42.28571,"AVALU":"WEEKS","ADTM":"2021-07-07 17:31:22","ADY":296,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-316","SUBJID":"id-316","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.57574,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-12","TRTSDTM":"2020-09-15 09:48:45","TRTEDTM":"2022-09-15 21:27:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-15","EOSDY":731,"LSTALVDT":"2022-10-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.28571,"AVALU":"WEEKS","ADTM":"2020-09-16 03:48:51","ADY":2,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-06 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.53026,"AVALU":"YEARS","ADTM":"2020-01-16 20:50:47","ADY":194,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.76727,"AVALU":"YEARS","ADTM":"2020-04-12 20:50:47","ADY":281,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.13171,"AVALU":"YEARS","ADTM":"2019-08-24 20:50:47","ADY":49,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":58.85714,"AVALU":"WEEKS","ADTM":"2020-08-20 21:17:30","ADY":412,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-329","SUBJID":"id-329","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.07281,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-03","TRTSDTM":"2019-07-06 20:50:47","TRTEDTM":"2021-07-06 08:29:11","EOSSTT":"COMPLETED","EOSDT":"2021-07-06","EOSDY":731,"LSTALVDT":"2021-07-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":49.85714,"AVALU":"WEEKS","ADTM":"2020-06-18 01:15:16","ADY":349,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.27174,"AVALU":"YEARS","ADTM":"2021-03-29 02:44:46","ADY":100,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10106,"AVALU":"YEARS","ADTM":"2021-01-25 02:44:46","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.28868,"AVALU":"YEARS","ADTM":"2021-04-04 02:44:46","ADY":106,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68.57143,"AVALU":"WEEKS","ADTM":"2022-04-12 12:28:43","ADY":480,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-33","SUBJID":"id-33","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.68515,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-17","TRTSDTM":"2020-12-19 02:44:46","TRTEDTM":"2022-12-19 14:23:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-19","EOSDY":731,"LSTALVDT":"2022-12-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":27.42857,"AVALU":"WEEKS","ADTM":"2021-06-28 08:25:04","ADY":192,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-08-24 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10537,"AVALU":"YEARS","ADTM":"2020-10-01 23:51:43","ADY":39,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-08-25 23:51:43","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.039,"AVALU":"YEARS","ADTM":"2020-09-07 23:51:43","ADY":15,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":88.85714,"AVALU":"WEEKS","ADTM":"2022-05-06 03:58:19","ADY":622,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-336","SUBJID":"id-336","SITEID":"CHN-1","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-21","TRTSDTM":"2020-08-23 23:51:43","TRTEDTM":"2022-08-24 11:30:07","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8,"AVALU":"WEEKS","ADTM":"2020-10-17 05:28:38","ADY":56,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-06 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04439,"AVALU":"YEARS","ADTM":"2020-06-22 23:25:59","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.57414,"AVALU":"YEARS","ADTM":"2021-01-01 23:25:59","ADY":210,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16485,"AVALU":"YEARS","ADTM":"2020-08-05 23:25:59","ADY":61,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":20.14286,"AVALU":"WEEKS","ADTM":"2020-10-23 21:42:37","ADY":141,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-337","SUBJID":"id-337","SITEID":"CHN-1","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.22759,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-03","TRTSDTM":"2020-06-05 23:25:59","TRTEDTM":"2022-06-06 11:04:23","EOSSTT":"COMPLETED","EOSDT":"2022-06-06","EOSDY":731,"LSTALVDT":"2022-06-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":45.28571,"AVALU":"WEEKS","ADTM":"2021-04-17 09:11:24","ADY":317,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.2601,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":95,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01799,"AVALU":"YEARS","ADTM":"2020-11-23 18:32:38","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.2601,"AVALU":"YEARS","ADTM":"2021-02-19 18:32:38","ADY":95,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16355,"AVALU":"YEARS","ADTM":"2021-01-15 18:32:38","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":87.71429,"AVALU":"WEEKS","ADTM":"2022-07-22 05:52:49","ADY":614,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-344","SUBJID":"id-344","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.58443,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-13","TRTSDTM":"2020-11-16 18:32:38","TRTEDTM":"2021-02-18 05:19:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":94,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":9,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.28571,"AVALU":"WEEKS","ADTM":"2020-11-17 18:26:52","ADY":2,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-22 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08589,"AVALU":"YEARS","ADTM":"2019-12-25 18:26:19","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.06981,"AVALU":"YEARS","ADTM":"2020-12-18 18:26:19","ADY":391,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06184,"AVALU":"YEARS","ADTM":"2019-12-16 18:26:19","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":62.85714,"AVALU":"WEEKS","ADTM":"2021-02-04 12:15:55","ADY":440,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-346","SUBJID":"id-346","SITEID":"CHN-1","AGE":21,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08004,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-20","TRTSDTM":"2019-11-23 18:26:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":34.57143,"AVALU":"WEEKS","ADTM":"2020-07-21 22:21:42","ADY":242,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-27 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-28 15:25:15","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09336,"AVALU":"YEARS","ADTM":"2020-10-31 15:25:15","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0818,"AVALU":"YEARS","ADTM":"2020-10-26 15:25:15","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":25.14286,"AVALU":"WEEKS","ADTM":"2021-03-20 06:21:00","ADY":176,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-347","SUBJID":"id-347","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15631,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-25","TRTSDTM":"2020-09-26 15:25:15","TRTEDTM":"2022-09-27 03:03:39","EOSSTT":"COMPLETED","EOSDT":"2022-09-27","EOSDY":731,"LSTALVDT":"2022-10-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":22.42857,"AVALU":"WEEKS","ADTM":"2021-03-01 10:42:56","ADY":157,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-08-02 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.399,"AVALU":"YEARS","ADTM":"2020-12-25 16:48:37","ADY":146,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.93381,"AVALU":"YEARS","ADTM":"2021-07-09 16:48:37","ADY":342,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.74115,"AVALU":"YEARS","ADTM":"2021-04-29 16:48:37","ADY":271,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":32.85714,"AVALU":"WEEKS","ADTM":"2021-03-18 03:00:37","ADY":230,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-351","SUBJID":"id-351","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.36685,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-29","TRTSDTM":"2020-08-01 16:48:37","TRTEDTM":"2022-08-02 04:27:01","EOSSTT":"COMPLETED","EOSDT":"2022-08-02","EOSDY":731,"LSTALVDT":"2022-08-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.85714,"AVALU":"WEEKS","ADTM":"2022-03-03 05:13:30","ADY":580,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-13 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.44065,"AVALU":"YEARS","ADTM":"2020-10-20 21:00:52","ADY":161,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20771,"AVALU":"YEARS","ADTM":"2020-07-27 21:00:52","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.22301,"AVALU":"YEARS","ADTM":"2020-08-02 21:00:52","ADY":82,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":79.42857,"AVALU":"WEEKS","ADTM":"2021-11-18 01:44:09","ADY":556,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-360","SUBJID":"id-360","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84995,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-10","TRTSDTM":"2020-05-12 21:00:52","TRTEDTM":"2022-05-13 08:39:16","EOSSTT":"COMPLETED","EOSDT":"2022-05-13","EOSDY":731,"LSTALVDT":"2022-05-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":12.28571,"AVALU":"WEEKS","ADTM":"2020-08-05 06:58:35","ADY":86,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.03012,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":11,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01405,"AVALU":"YEARS","ADTM":"2021-02-15 05:28:52","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02359,"AVALU":"YEARS","ADTM":"2021-02-18 05:28:52","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03012,"AVALU":"YEARS","ADTM":"2021-02-20 05:28:52","ADY":11,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42,"AVALU":"WEEKS","ADTM":"2021-11-29 03:01:11","ADY":294,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-371","SUBJID":"id-371","SITEID":"CHN-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.32686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-02-07","TRTSDTM":"2021-02-09 05:28:52","TRTEDTM":"2021-02-19 19:06:01","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":11,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":25.28571,"AVALU":"WEEKS","ADTM":"2021-08-04 05:43:01","ADY":177,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-29 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":12} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08879,"AVALU":"YEARS","ADTM":"2019-11-02 23:36:21","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02378,"AVALU":"YEARS","ADTM":"2019-10-09 23:36:21","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04317,"AVALU":"YEARS","ADTM":"2019-10-16 23:36:21","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42,"AVALU":"WEEKS","ADTM":"2020-07-19 18:45:16","ADY":294,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-376","SUBJID":"id-376","SITEID":"CHN-1","AGE":41,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":21.39337,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-26","TRTSDTM":"2019-09-30 23:36:21","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.14286,"AVALU":"WEEKS","ADTM":"2020-02-03 23:57:46","ADY":127,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.43321,"AVALU":"YEARS","ADTM":"2020-12-08 11:53:06","ADY":159,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.00084,"AVALU":"YEARS","ADTM":"2020-07-03 11:53:06","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.32252,"AVALU":"YEARS","ADTM":"2020-10-28 11:53:06","ADY":118,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":35.14286,"AVALU":"WEEKS","ADTM":"2021-03-04 07:41:24","ADY":246,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-389","SUBJID":"id-389","SITEID":"CHN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.82133,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-07-02 11:53:06","TRTEDTM":"2022-07-02 23:31:30","EOSSTT":"COMPLETED","EOSDT":"2022-07-02","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-07-02 11:53:06","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.42916,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":522,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.14394,"AVALU":"YEARS","ADTM":"2019-11-08 18:21:14","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.36279,"AVALU":"YEARS","ADTM":"2020-01-27 18:21:14","ADY":133,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.32461,"AVALU":"YEARS","ADTM":"2020-01-13 18:21:14","ADY":119,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":60.28571,"AVALU":"WEEKS","ADTM":"2020-11-10 05:08:45","ADY":422,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-400","SUBJID":"id-400","SITEID":"CHN-1","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.77615,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-13","TRTSDTM":"2019-09-16 18:21:14","TRTEDTM":"2021-02-18 14:09:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":521,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":6.28571,"AVALU":"WEEKS","ADTM":"2019-10-29 00:53:27","ADY":44,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-18 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.42632,"AVALU":"YEARS","ADTM":"2020-06-23 04:48:47","ADY":156,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.3985,"AVALU":"YEARS","ADTM":"2020-06-13 04:48:47","ADY":146,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.36563,"AVALU":"YEARS","ADTM":"2020-06-01 04:48:47","ADY":134,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":38.42857,"AVALU":"WEEKS","ADTM":"2020-10-13 20:54:53","ADY":269,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-47","SUBJID":"id-47","SITEID":"CHN-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.39866,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 04:48:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":96,"AVALU":"WEEKS","ADTM":"2021-11-20 01:30:37","ADY":672,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-06 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00455,"AVALU":"YEARS","ADTM":"2019-11-09 07:20:22","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.35867,"AVALU":"YEARS","ADTM":"2020-03-18 07:20:22","ADY":132,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.52867,"AVALU":"YEARS","ADTM":"2020-05-19 07:20:22","ADY":194,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":21.85714,"AVALU":"WEEKS","ADTM":"2020-04-07 00:27:30","ADY":153,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-53","SUBJID":"id-53","SITEID":"CHN-1","AGE":48,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90562,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-04","TRTSDTM":"2019-11-07 07:20:22","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-11-07 07:20:22","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-22 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.41612,"AVALU":"YEARS","ADTM":"2021-04-23 01:33:15","ADY":152,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-23 01:33:15","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.37129,"AVALU":"YEARS","ADTM":"2021-04-07 01:33:15","ADY":136,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":18.57143,"AVALU":"WEEKS","ADTM":"2021-03-31 13:38:34","ADY":130,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-62","SUBJID":"id-62","SITEID":"CHN-1","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.50974,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-22 01:33:15","TRTEDTM":"2022-11-22 13:11:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-22","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":30.28571,"AVALU":"WEEKS","ADTM":"2021-06-21 15:56:05","ADY":212,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01989,"AVALU":"YEARS","ADTM":"2019-05-06 02:39:34","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08889,"AVALU":"YEARS","ADTM":"2019-05-31 02:39:34","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06457,"AVALU":"YEARS","ADTM":"2019-05-22 02:39:34","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":8.42857,"AVALU":"WEEKS","ADTM":"2019-06-25 17:30:35","ADY":59,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-64","SUBJID":"id-64","SITEID":"CHN-1","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.16063,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-28 02:39:34","TRTEDTM":"2021-04-27 14:17:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-04-28 02:39:34","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-05 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-06 18:29:59","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-06 18:29:59","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08367,"AVALU":"YEARS","ADTM":"2020-05-05 18:29:59","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":69,"AVALU":"WEEKS","ADTM":"2021-07-30 15:18:15","ADY":483,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-69","SUBJID":"id-69","SITEID":"CHN-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.54,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-01","TRTSDTM":"2020-04-04 18:29:59","TRTEDTM":"2022-04-05 06:08:23","EOSSTT":"COMPLETED","EOSDT":"2022-04-05","EOSDY":731,"LSTALVDT":"2022-04-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":43.14286,"AVALU":"WEEKS","ADTM":"2021-01-30 20:02:52","ADY":302,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.03405,"AVALU":"YEARS","ADTM":"2021-01-06 12:15:46","ADY":13,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01066,"AVALU":"YEARS","ADTM":"2020-12-28 12:15:46","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0067,"AVALU":"YEARS","ADTM":"2020-12-27 12:15:46","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":28.85714,"AVALU":"WEEKS","ADTM":"2021-07-13 10:09:14","ADY":202,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-71","SUBJID":"id-71","SITEID":"CHN-1","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":7.70143,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-12-21","TRTSDTM":"2020-12-24 12:15:46","TRTEDTM":"2022-12-24 23:54:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-24","EOSDY":731,"LSTALVDT":"2023-01-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":24.14286,"AVALU":"WEEKS","ADTM":"2021-06-10 11:49:18","ADY":169,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-18 03:52:03","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-18 03:52:03","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.23727,"AVALU":"YEARS","ADTM":"2020-04-14 03:52:03","ADY":87,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":80.28571,"AVALU":"WEEKS","ADTM":"2021-08-01 20:40:05","ADY":562,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-74","SUBJID":"id-74","SITEID":"CHN-1","AGE":23,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.80318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-18","TRTSDTM":"2020-01-18 03:52:03","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":24,"AVALU":"WEEKS","ADTM":"2020-07-03 08:49:04","ADY":168,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-21 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-22 16:10:24","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-02-22 16:10:24","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16339,"AVALU":"YEARS","ADTM":"2020-04-21 16:10:24","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":98.71429,"AVALU":"WEEKS","ADTM":"2022-01-11 12:40:22","ADY":691,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-78","SUBJID":"id-78","SITEID":"CHN-1","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.74209,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-17","TRTSDTM":"2020-02-21 16:10:24","TRTEDTM":"2022-02-21 03:48:48","EOSSTT":"COMPLETED","EOSDT":"2022-02-21","EOSDY":731,"LSTALVDT":"2022-03-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":37.28571,"AVALU":"WEEKS","ADTM":"2020-11-07 05:32:21","ADY":261,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01927,"AVALU":"YEARS","ADTM":"2020-05-23 00:05:25","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.35474,"AVALU":"YEARS","ADTM":"2020-09-22 00:05:25","ADY":130,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.19138,"AVALU":"YEARS","ADTM":"2020-07-24 00:05:25","ADY":70,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":43.28571,"AVALU":"WEEKS","ADTM":"2021-03-13 23:03:13","ADY":303,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-86","SUBJID":"id-86","SITEID":"CHN-1","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.36363,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-11","TRTSDTM":"2020-05-15 00:05:25","TRTEDTM":"2022-05-15 11:43:49","EOSSTT":"COMPLETED","EOSDT":"2022-05-15","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":16.42857,"AVALU":"WEEKS","ADTM":"2020-09-06 15:43:23","ADY":115,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.08145,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":395,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.52883,"AVALU":"YEARS","ADTM":"2020-08-01 07:59:20","ADY":194,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.13335,"AVALU":"YEARS","ADTM":"2020-03-09 07:59:20","ADY":49,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00945,"AVALU":"YEARS","ADTM":"2020-01-24 07:59:20","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":51.85714,"AVALU":"WEEKS","ADTM":"2021-01-16 21:49:16","ADY":363,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-1-id-97","SUBJID":"id-97","SITEID":"CHN-1","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-1","INVNAM":"Dr. CHN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.49296,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-20 07:59:20","TRTEDTM":"2021-02-17 04:09:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":394,"DCSREAS":"DEATH","DTHDT":"2021-04-02","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.71429,"AVALU":"WEEKS","ADTM":"2020-07-24 14:08:20","ADY":187,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.78303,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":286,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.78303,"AVALU":"YEARS","ADTM":"2021-02-19 18:31:55","ADY":286,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.46119,"AVALU":"YEARS","ADTM":"2020-10-25 18:31:55","ADY":169,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.27326,"AVALU":"YEARS","ADTM":"2020-08-17 18:31:55","ADY":100,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":11,"AVALU":"WEEKS","ADTM":"2020-07-24 18:20:14","ADY":77,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-10-id-380","SUBJID":"id-380","SITEID":"CHN-10","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-10","INVNAM":"Dr. CHN-10 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.37548,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-05","TRTSDTM":"2020-05-09 18:31:55","TRTEDTM":"2021-02-18 01:52:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":285,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.71429,"AVALU":"WEEKS","ADTM":"2020-09-16 12:07:23","ADY":131,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.10678,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":39,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10678,"AVALU":"YEARS","ADTM":"2021-02-18 15:31:29","ADY":39,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10355,"AVALU":"YEARS","ADTM":"2021-02-17 15:31:29","ADY":38,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.10108,"AVALU":"YEARS","ADTM":"2021-02-16 15:31:29","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2021-01-10 15:31:29","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-113","SUBJID":"id-113","SITEID":"CHN-11","AGE":38,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.86591,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-06","TRTSDTM":"2021-01-10 15:31:29","TRTEDTM":"2021-02-17 16:56:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":39,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":74.42857,"AVALU":"WEEKS","ADTM":"2022-06-14 18:38:02","ADY":521,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-16 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.24346,"AVALU":"YEARS","ADTM":"2020-06-12 18:50:10","ADY":89,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-17 18:50:10","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11442,"AVALU":"YEARS","ADTM":"2020-04-26 18:50:10","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-03-15 18:50:10","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-116","SUBJID":"id-116","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.31633,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-11","TRTSDTM":"2020-03-15 18:50:10","TRTEDTM":"2022-03-16 06:28:34","EOSSTT":"COMPLETED","EOSDT":"2022-03-16","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":33.71429,"AVALU":"WEEKS","ADTM":"2020-11-05 19:35:13","ADY":236,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.59069,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":581,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.59069,"AVALU":"YEARS","ADTM":"2021-02-14 08:47:31","ADY":581,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20325,"AVALU":"YEARS","ADTM":"2019-09-27 08:47:31","ADY":75,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.22031,"AVALU":"YEARS","ADTM":"2019-10-03 08:47:31","ADY":81,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":22.57143,"AVALU":"WEEKS","ADTM":"2019-12-18 08:09:34","ADY":158,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-124","SUBJID":"id-124","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36798,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-12","TRTSDTM":"2019-07-14 08:47:31","TRTEDTM":"2021-02-13 07:16:36","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":580,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":88.14286,"AVALU":"WEEKS","ADTM":"2021-03-21 23:11:54","ADY":617,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.97467,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":356,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.03419,"AVALU":"YEARS","ADTM":"2020-03-11 13:11:51","ADY":13,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.78687,"AVALU":"YEARS","ADTM":"2020-12-11 13:11:51","ADY":288,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.97467,"AVALU":"YEARS","ADTM":"2021-02-17 13:11:51","ADY":356,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":38.28571,"AVALU":"WEEKS","ADTM":"2020-11-20 13:24:23","ADY":268,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-132","SUBJID":"id-132","SITEID":"CHN-11","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.94925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-02-25","TRTSDTM":"2020-02-27 13:11:51","TRTEDTM":"2021-02-16 21:14:03","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":356,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":100.85714,"AVALU":"WEEKS","ADTM":"2022-02-01 03:41:33","ADY":706,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-10 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-11 20:22:02","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23746,"AVALU":"YEARS","ADTM":"2021-04-06 20:22:02","ADY":87,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-11 20:22:02","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":91.14286,"AVALU":"WEEKS","ADTM":"2022-10-08 03:54:25","ADY":638,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-146","SUBJID":"id-146","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.15901,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-05","TRTSDTM":"2021-01-09 20:22:02","TRTEDTM":"2023-01-10 08:00:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-10","EOSDY":731,"LSTALVDT":"2023-01-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":33,"AVALU":"WEEKS","ADTM":"2021-08-27 17:04:12","ADY":231,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-14 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-15 20:57:39","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.35339,"AVALU":"YEARS","ADTM":"2021-02-20 20:57:39","ADY":130,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-15 20:57:39","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-10-13 20:57:39","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-153","SUBJID":"id-153","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.79286,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-10-09","TRTSDTM":"2020-10-13 20:57:39","TRTEDTM":"2022-10-14 08:36:03","EOSSTT":"COMPLETED","EOSDT":"2022-10-14","EOSDY":731,"LSTALVDT":"2022-11-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":13,"AVALU":"WEEKS","ADTM":"2021-01-11 15:05:53","ADY":91,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.02253,"AVALU":"YEARS","ADTM":"2020-07-29 00:37:49","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-21 00:37:49","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.3778,"AVALU":"YEARS","ADTM":"2020-12-05 00:37:49","ADY":138,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68,"AVALU":"WEEKS","ADTM":"2021-11-07 23:20:17","ADY":476,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-158","SUBJID":"id-158","SITEID":"CHN-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.18135,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-17","TRTSDTM":"2020-07-20 00:37:49","TRTEDTM":"2022-07-20 12:16:13","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":78.42857,"AVALU":"WEEKS","ADTM":"2022-01-19 06:23:36","ADY":549,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-07 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-08 14:11:13","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09918,"AVALU":"YEARS","ADTM":"2019-12-15 14:11:13","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-08 14:11:13","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-11-08 14:11:13","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-167","SUBJID":"id-167","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.96265,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-07","TRTSDTM":"2019-11-08 14:11:13","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":53.42857,"AVALU":"WEEKS","ADTM":"2020-11-15 05:47:09","ADY":374,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-20 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-21 20:53:35","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.72659,"AVALU":"YEARS","ADTM":"2021-02-09 20:53:35","ADY":266,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.64104,"AVALU":"YEARS","ADTM":"2021-01-09 20:53:35","ADY":235,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":26.28571,"AVALU":"WEEKS","ADTM":"2020-11-18 13:35:18","ADY":184,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-174","SUBJID":"id-174","SITEID":"CHN-11","AGE":41,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.08848,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-19 20:53:35","TRTEDTM":"2022-05-20 08:31:59","EOSSTT":"COMPLETED","EOSDT":"2022-05-20","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":86.28571,"AVALU":"WEEKS","ADTM":"2022-01-12 09:27:20","ADY":604,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-05-03 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.03754,"AVALU":"YEARS","ADTM":"2019-05-18 08:17:38","ADY":14,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-05-04 08:17:38","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04317,"AVALU":"YEARS","ADTM":"2019-05-20 08:17:38","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":69.42857,"AVALU":"WEEKS","ADTM":"2020-08-31 00:07:05","ADY":486,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-184","SUBJID":"id-184","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.63913,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-04","TRTSDTM":"2019-05-04 08:17:38","TRTEDTM":"2021-05-03 19:56:02","EOSSTT":"COMPLETED","EOSDT":"2021-05-03","EOSDY":731,"LSTALVDT":"2021-05-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":9.42857,"AVALU":"WEEKS","ADTM":"2019-07-08 12:02:53","ADY":66,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-25 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-26 00:34:44","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.17013,"AVALU":"YEARS","ADTM":"2020-02-27 00:34:44","ADY":63,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.10382,"AVALU":"YEARS","ADTM":"2020-02-02 00:34:44","ADY":38,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":81.42857,"AVALU":"WEEKS","ADTM":"2021-07-17 18:42:11","ADY":570,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-192","SUBJID":"id-192","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.76819,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-26 00:34:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.14286,"AVALU":"WEEKS","ADTM":"2020-04-30 17:28:40","ADY":127,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-13 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-14 04:27:15","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.04633,"AVALU":"YEARS","ADTM":"2020-07-30 04:27:15","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.41065,"AVALU":"YEARS","ADTM":"2020-12-10 04:27:15","ADY":150,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":25.85714,"AVALU":"WEEKS","ADTM":"2021-01-09 12:54:20","ADY":181,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-2","SUBJID":"id-2","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.01534,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-09","TRTSDTM":"2020-07-13 04:27:15","TRTEDTM":"2022-07-13 16:05:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-13","EOSDY":731,"LSTALVDT":"2022-08-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.42857,"AVALU":"WEEKS","ADTM":"2020-11-18 00:48:55","ADY":129,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-01 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11044,"AVALU":"YEARS","ADTM":"2019-04-11 13:33:03","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.19942,"AVALU":"YEARS","ADTM":"2019-05-13 13:33:03","ADY":73,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.35482,"AVALU":"YEARS","ADTM":"2019-07-09 13:33:03","ADY":130,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":45.85714,"AVALU":"WEEKS","ADTM":"2020-01-15 07:25:04","ADY":321,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-220","SUBJID":"id-220","SITEID":"CHN-11","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":10.26273,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-27","TRTSDTM":"2019-03-01 13:33:03","TRTEDTM":"2021-03-01 01:11:27","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":95.71429,"AVALU":"WEEKS","ADTM":"2020-12-29 18:05:38","ADY":670,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.97741,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":357,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.97741,"AVALU":"YEARS","ADTM":"2021-02-16 06:19:34","ADY":357,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.97741,"AVALU":"YEARS","ADTM":"2021-02-16 06:19:34","ADY":357,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.36938,"AVALU":"YEARS","ADTM":"2020-07-09 06:19:34","ADY":135,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.28571,"AVALU":"WEEKS","ADTM":"2021-01-13 02:59:48","ADY":324,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-222","SUBJID":"id-222","SITEID":"CHN-11","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.65329,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-22","TRTSDTM":"2020-02-25 06:19:34","TRTEDTM":"2021-02-15 18:04:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":50.85714,"AVALU":"WEEKS","ADTM":"2021-02-14 09:18:54","ADY":356,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-30 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04472,"AVALU":"YEARS","ADTM":"2020-11-15 16:26:55","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.73005,"AVALU":"YEARS","ADTM":"2021-07-23 16:26:55","ADY":267,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02827,"AVALU":"YEARS","ADTM":"2020-11-09 16:26:55","ADY":11,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":36.71429,"AVALU":"WEEKS","ADTM":"2021-07-12 12:57:14","ADY":257,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-24","SUBJID":"id-24","SITEID":"CHN-11","AGE":46,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.98174,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-25","TRTSDTM":"2020-10-29 16:26:55","TRTEDTM":"2022-10-30 04:05:19","EOSSTT":"COMPLETED","EOSDT":"2022-10-30","EOSDY":731,"LSTALVDT":"2022-11-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.57143,"AVALU":"WEEKS","ADTM":"2020-12-27 02:08:44","ADY":60,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04123,"AVALU":"YEARS","ADTM":"2020-08-02 02:38:14","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.41124,"AVALU":"YEARS","ADTM":"2020-12-15 02:38:14","ADY":151,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14213,"AVALU":"YEARS","ADTM":"2020-09-07 02:38:14","ADY":52,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":78.71429,"AVALU":"WEEKS","ADTM":"2022-01-18 12:32:46","ADY":551,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-244","SUBJID":"id-244","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.26417,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-14","TRTSDTM":"2020-07-17 02:38:14","TRTEDTM":"2022-07-17 14:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-07-17","EOSDY":731,"LSTALVDT":"2022-08-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":50.57143,"AVALU":"WEEKS","ADTM":"2021-07-05 05:18:43","ADY":354,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-22 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.28002,"AVALU":"YEARS","ADTM":"2021-04-04 05:20:30","ADY":103,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.17082,"AVALU":"YEARS","ADTM":"2021-02-23 05:20:30","ADY":63,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04332,"AVALU":"YEARS","ADTM":"2021-01-07 05:20:30","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":56.85714,"AVALU":"WEEKS","ADTM":"2022-01-23 02:40:48","ADY":398,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-246","SUBJID":"id-246","SITEID":"CHN-11","AGE":31,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.11334,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 05:20:30","TRTEDTM":"2022-12-22 16:58:54","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":97.28571,"AVALU":"WEEKS","ADTM":"2022-11-02 01:46:01","ADY":681,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-28 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00674,"AVALU":"YEARS","ADTM":"2019-07-31 23:43:43","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.45691,"AVALU":"YEARS","ADTM":"2020-01-11 23:43:43","ADY":167,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06338,"AVALU":"YEARS","ADTM":"2019-08-21 23:43:43","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":84.57143,"AVALU":"WEEKS","ADTM":"2021-03-10 02:41:14","ADY":592,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-247","SUBJID":"id-247","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.01895,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-27","TRTSDTM":"2019-07-28 23:43:43","TRTEDTM":"2021-07-28 11:22:07","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":64.71429,"AVALU":"WEEKS","ADTM":"2020-10-22 23:52:09","ADY":453,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.4405,"AVALU":"YEARS","ADTM":"2020-08-25 00:24:27","ADY":161,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.16941,"AVALU":"YEARS","ADTM":"2020-05-18 00:24:27","ADY":62,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-18 00:24:27","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":4.28571,"AVALU":"WEEKS","ADTM":"2020-04-15 00:20:30","ADY":30,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-256","SUBJID":"id-256","SITEID":"CHN-11","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.65204,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-14","TRTSDTM":"2020-03-17 00:24:27","TRTEDTM":"2022-03-17 12:02:51","EOSSTT":"COMPLETED","EOSDT":"2022-03-17","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60.85714,"AVALU":"WEEKS","ADTM":"2021-05-16 09:33:13","ADY":426,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-16 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.09151,"AVALU":"YEARS","ADTM":"2020-12-19 17:19:47","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-17 17:19:47","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.22864,"AVALU":"YEARS","ADTM":"2021-02-07 17:19:47","ADY":84,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":77.85714,"AVALU":"WEEKS","ADTM":"2022-05-13 06:16:15","ADY":545,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-257","SUBJID":"id-257","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.83771,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-15 17:19:47","TRTEDTM":"2022-11-16 04:58:11","EOSSTT":"COMPLETED","EOSDT":"2022-11-16","EOSDY":731,"LSTALVDT":"2022-12-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":95.42857,"AVALU":"WEEKS","ADTM":"2022-09-13 01:36:27","ADY":668,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.86995,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":683,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":12} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.02243,"AVALU":"YEARS","ADTM":"2019-04-12 21:49:52","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.33761,"AVALU":"YEARS","ADTM":"2019-08-05 21:49:52","ADY":124,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04209,"AVALU":"YEARS","ADTM":"2019-04-19 21:49:52","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":86.14286,"AVALU":"WEEKS","ADTM":"2020-11-25 00:34:56","ADY":603,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-263","SUBJID":"id-263","SITEID":"CHN-11","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.82823,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-03 21:49:52","TRTEDTM":"2021-02-13 23:58:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":683,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":58,"AVALU":"WEEKS","ADTM":"2020-05-12 23:00:17","ADY":406,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.69921,"AVALU":"YEARS","ADTM":"2020-07-31 05:16:02","ADY":256,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.80892,"AVALU":"YEARS","ADTM":"2020-09-09 05:16:02","ADY":296,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03042,"AVALU":"YEARS","ADTM":"2019-11-30 05:16:02","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.42857,"AVALU":"WEEKS","ADTM":"2020-03-18 05:05:24","ADY":122,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-27","SUBJID":"id-27","SITEID":"CHN-11","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":12.81348,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-14","TRTSDTM":"2019-11-18 05:16:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-11-18 05:16:02","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.14537,"AVALU":"YEARS","ADTM":"2020-10-17 06:38:53","ADY":54,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23912,"AVALU":"YEARS","ADTM":"2020-11-20 06:38:53","ADY":88,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05177,"AVALU":"YEARS","ADTM":"2020-09-12 06:38:53","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.42857,"AVALU":"WEEKS","ADTM":"2021-07-14 00:22:05","ADY":325,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-278","SUBJID":"id-278","SITEID":"CHN-11","AGE":47,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":2.07981,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-23","TRTSDTM":"2020-08-24 06:38:53","TRTEDTM":"2022-08-24 18:17:17","EOSSTT":"COMPLETED","EOSDT":"2022-08-24","EOSDY":731,"LSTALVDT":"2022-09-21","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":47.42857,"AVALU":"WEEKS","ADTM":"2021-07-21 16:13:10","ADY":332,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-29 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.35709,"AVALU":"YEARS","ADTM":"2021-02-06 18:48:16","ADY":131,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-30 18:48:16","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.51421,"AVALU":"YEARS","ADTM":"2021-04-04 18:48:16","ADY":188,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":84.57143,"AVALU":"WEEKS","ADTM":"2022-05-12 04:39:22","ADY":592,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-289","SUBJID":"id-289","SITEID":"CHN-11","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.91181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-26","TRTSDTM":"2020-09-28 18:48:16","TRTEDTM":"2022-09-29 06:26:40","EOSSTT":"COMPLETED","EOSDT":"2022-09-29","EOSDY":731,"LSTALVDT":"2022-10-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.57143,"AVALU":"WEEKS","ADTM":"2021-09-23 05:03:55","ADY":361,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-01 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-02 13:58:42","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.71149,"AVALU":"YEARS","ADTM":"2021-07-18 13:58:42","ADY":260,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.09478,"AVALU":"YEARS","ADTM":"2020-12-05 13:58:42","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":34.57143,"AVALU":"WEEKS","ADTM":"2021-06-29 19:10:09","ADY":242,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-291","SUBJID":"id-291","SITEID":"CHN-11","AGE":50,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30136,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 13:58:42","TRTEDTM":"2022-11-01 01:37:06","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":38.28571,"AVALU":"WEEKS","ADTM":"2021-07-25 12:23:15","ADY":268,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-29 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00645,"AVALU":"YEARS","ADTM":"2020-03-31 15:13:07","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09486,"AVALU":"YEARS","ADTM":"2020-05-02 15:13:07","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-30 15:13:07","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.85714,"AVALU":"WEEKS","ADTM":"2020-07-30 23:33:04","ADY":125,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-298","SUBJID":"id-298","SITEID":"CHN-11","AGE":31,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 15:13:07","TRTEDTM":"2022-03-29 02:51:31","EOSSTT":"COMPLETED","EOSDT":"2022-03-29","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":96.71429,"AVALU":"WEEKS","ADTM":"2022-02-02 19:51:51","ADY":677,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.73648,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":269,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.48946,"AVALU":"YEARS","ADTM":"2020-11-15 22:29:19","ADY":179,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01933,"AVALU":"YEARS","ADTM":"2020-05-28 22:29:19","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.6085,"AVALU":"YEARS","ADTM":"2020-12-29 22:29:19","ADY":223,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":32.28571,"AVALU":"WEEKS","ADTM":"2020-12-31 23:39:13","ADY":226,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-317","SUBJID":"id-317","SITEID":"CHN-11","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.05702,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-19","TRTSDTM":"2020-05-20 22:29:19","TRTEDTM":"2021-02-12 20:19:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":268,"DCSREAS":"DEATH","DTHDT":"2021-02-22","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":66.42857,"AVALU":"WEEKS","ADTM":"2021-08-27 11:04:06","ADY":465,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.47844,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":540,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.47844,"AVALU":"YEARS","ADTM":"2021-02-18 09:31:29","ADY":540,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.72649,"AVALU":"YEARS","ADTM":"2020-05-20 09:31:29","ADY":266,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.09204,"AVALU":"YEARS","ADTM":"2019-10-01 09:31:29","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":84.71429,"AVALU":"WEEKS","ADTM":"2021-04-11 18:13:00","ADY":593,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-318","SUBJID":"id-318","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.39501,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-24","TRTSDTM":"2019-08-28 09:31:29","TRTEDTM":"2021-02-17 05:23:43","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":539,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-10","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":58.85714,"AVALU":"WEEKS","ADTM":"2020-10-12 08:47:54","ADY":412,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-14 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":12} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07156,"AVALU":"YEARS","ADTM":"2020-12-10 19:19:24","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11747,"AVALU":"YEARS","ADTM":"2020-12-26 19:19:24","ADY":43,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11602,"AVALU":"YEARS","ADTM":"2020-12-26 19:19:24","ADY":43,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-11-13 19:19:24","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-349","SUBJID":"id-349","SITEID":"CHN-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.32398,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-11","TRTSDTM":"2020-11-13 19:19:24","TRTEDTM":"2022-11-14 06:57:48","EOSSTT":"COMPLETED","EOSDT":"2022-11-14","EOSDY":731,"LSTALVDT":"2022-12-10","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":25.28571,"AVALU":"WEEKS","ADTM":"2021-05-08 05:24:42","ADY":177,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.42697,"AVALU":"YEARS","ADTM":"2020-07-15 04:38:45","ADY":156,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08101,"AVALU":"YEARS","ADTM":"2020-03-11 04:38:45","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04083,"AVALU":"YEARS","ADTM":"2020-02-25 04:38:45","ADY":15,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":23.28571,"AVALU":"WEEKS","ADTM":"2020-07-21 02:37:01","ADY":163,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-354","SUBJID":"id-354","SITEID":"CHN-11","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.59138,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-07","TRTSDTM":"2020-02-10 04:38:45","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":2,"AVALU":"WEEKS","ADTM":"2020-02-23 14:56:24","ADY":14,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-12 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.47383,"AVALU":"YEARS","ADTM":"2020-09-02 10:25:48","ADY":174,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-13 10:25:48","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.33258,"AVALU":"YEARS","ADTM":"2020-07-12 10:25:48","ADY":122,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-03-12 10:25:48","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-356","SUBJID":"id-356","SITEID":"CHN-11","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.24981,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-12 10:25:48","TRTEDTM":"2022-03-12 22:04:12","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.28571,"AVALU":"WEEKS","ADTM":"2020-07-17 12:54:08","ADY":128,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-12-03 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-12-04 13:28:02","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.98368,"AVALU":"YEARS","ADTM":"2021-11-27 13:28:02","ADY":360,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04302,"AVALU":"YEARS","ADTM":"2020-12-18 13:28:02","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":103,"AVALU":"WEEKS","ADTM":"2022-11-22 12:09:15","ADY":721,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-358","SUBJID":"id-358","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.39002,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-28","TRTSDTM":"2020-12-02 13:28:02","TRTEDTM":"2022-12-03 01:06:26","EOSSTT":"COMPLETED","EOSDT":"2022-12-03","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":71,"AVALU":"WEEKS","ADTM":"2022-04-12 05:37:44","ADY":497,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.82136,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":300,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.12644,"AVALU":"YEARS","ADTM":"2020-06-09 02:47:53","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.62571,"AVALU":"YEARS","ADTM":"2020-12-08 02:47:53","ADY":229,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14841,"AVALU":"YEARS","ADTM":"2020-06-17 02:47:53","ADY":55,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":34.57143,"AVALU":"WEEKS","ADTM":"2020-12-20 04:35:30","ADY":242,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-362","SUBJID":"id-362","SITEID":"CHN-11","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.60836,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-23","TRTSDTM":"2020-04-23 02:47:53","TRTEDTM":"2021-02-16 11:37:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":300,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":103.42857,"AVALU":"WEEKS","ADTM":"2022-04-16 04:45:55","ADY":724,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17309,"AVALU":"YEARS","ADTM":"2021-02-22 05:12:22","ADY":64,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.84178,"AVALU":"YEARS","ADTM":"2021-10-24 05:12:22","ADY":308,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.99852,"AVALU":"YEARS","ADTM":"2021-12-20 05:12:22","ADY":365,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":81.42857,"AVALU":"WEEKS","ADTM":"2022-07-12 19:05:01","ADY":570,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-364","SUBJID":"id-364","SITEID":"CHN-11","AGE":48,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.68839,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-20","TRTSDTM":"2020-12-20 05:12:22","TRTEDTM":"2022-12-20 16:50:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-20","EOSDY":731,"LSTALVDT":"2023-01-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":71,"AVALU":"WEEKS","ADTM":"2022-04-30 00:59:05","ADY":497,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-10 16:18:25","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01087,"AVALU":"YEARS","ADTM":"2020-01-14 16:18:25","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.17411,"AVALU":"YEARS","ADTM":"2020-03-14 16:18:25","ADY":64,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":35.85714,"AVALU":"WEEKS","ADTM":"2020-09-16 20:05:34","ADY":251,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-377","SUBJID":"id-377","SITEID":"CHN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.66603,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-10","TRTSDTM":"2020-01-10 16:18:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":99.28571,"AVALU":"WEEKS","ADTM":"2021-12-04 13:57:58","ADY":695,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-29 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-30 00:38:38","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-30 00:38:38","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00451,"AVALU":"YEARS","ADTM":"2019-08-01 00:38:38","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":52.14286,"AVALU":"WEEKS","ADTM":"2020-07-28 11:53:11","ADY":365,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-379","SUBJID":"id-379","SITEID":"CHN-11","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.84651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-29","TRTSDTM":"2019-07-30 00:38:38","TRTEDTM":"2021-07-29 12:17:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-29","EOSDY":731,"LSTALVDT":"2021-08-21","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":93,"AVALU":"WEEKS","ADTM":"2021-05-10 18:00:53","ADY":651,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.66461,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":608,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.34354,"AVALU":"YEARS","ADTM":"2019-10-21 00:51:04","ADY":126,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07539,"AVALU":"YEARS","ADTM":"2019-07-15 00:51:04","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.25757,"AVALU":"YEARS","ADTM":"2019-09-20 00:51:04","ADY":95,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":80.85714,"AVALU":"WEEKS","ADTM":"2021-01-02 06:40:58","ADY":566,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-38","SUBJID":"id-38","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.48993,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-13","TRTSDTM":"2019-06-17 00:51:04","TRTEDTM":"2021-02-13 07:54:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":608,"DCSREAS":"DEATH","DTHDT":"2021-02-24","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":103.42857,"AVALU":"WEEKS","ADTM":"2021-06-09 15:42:10","ADY":724,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-18 12:45:32","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.12659,"AVALU":"YEARS","ADTM":"2021-03-05 12:45:32","ADY":412,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.3771,"AVALU":"YEARS","ADTM":"2020-06-04 12:45:32","ADY":138,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":79.57143,"AVALU":"WEEKS","ADTM":"2021-07-27 19:31:36","ADY":557,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-386","SUBJID":"id-386","SITEID":"CHN-11","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.56042,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-18 12:45:32","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-01-18 12:45:32","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-16 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-17 20:54:57","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.02252,"AVALU":"YEARS","ADTM":"2021-05-24 20:54:57","ADY":374,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.30712,"AVALU":"YEARS","ADTM":"2020-09-05 20:54:57","ADY":113,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":23.28571,"AVALU":"WEEKS","ADTM":"2020-10-24 08:02:01","ADY":163,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-391","SUBJID":"id-391","SITEID":"CHN-11","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.9676,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-12","TRTSDTM":"2020-05-15 20:54:57","TRTEDTM":"2022-05-16 08:33:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-16","EOSDY":731,"LSTALVDT":"2022-06-04","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-05-15 20:54:57","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-28 09:53:57","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0014,"AVALU":"YEARS","ADTM":"2019-09-29 09:53:57","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05935,"AVALU":"YEARS","ADTM":"2019-10-20 09:53:57","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":30.85714,"AVALU":"WEEKS","ADTM":"2020-04-30 17:27:31","ADY":216,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-392","SUBJID":"id-392","SITEID":"CHN-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.77395,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-24","TRTSDTM":"2019-09-28 09:53:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":66.28571,"AVALU":"WEEKS","ADTM":"2021-01-03 09:15:13","ADY":464,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-08-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00727,"AVALU":"YEARS","ADTM":"2019-08-24 06:25:19","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.51642,"AVALU":"YEARS","ADTM":"2021-02-25 06:25:19","ADY":554,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.2947,"AVALU":"YEARS","ADTM":"2019-12-07 06:25:19","ADY":108,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":88.57143,"AVALU":"WEEKS","ADTM":"2021-05-01 06:43:44","ADY":620,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-54","SUBJID":"id-54","SITEID":"CHN-11","AGE":26,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.81516,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-17","TRTSDTM":"2019-08-21 06:25:19","TRTEDTM":"2021-08-20 18:03:43","EOSSTT":"COMPLETED","EOSDT":"2021-08-20","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":90.71429,"AVALU":"WEEKS","ADTM":"2021-05-16 09:33:36","ADY":635,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.24367,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":89,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06636,"AVALU":"YEARS","ADTM":"2020-12-18 16:44:42","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.24367,"AVALU":"YEARS","ADTM":"2021-02-20 16:44:42","ADY":89,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04178,"AVALU":"YEARS","ADTM":"2020-12-09 16:44:42","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.14286,"AVALU":"WEEKS","ADTM":"2021-03-22 23:16:14","ADY":120,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-55","SUBJID":"id-55","SITEID":"CHN-11","AGE":43,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.30181,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-20","TRTSDTM":"2020-11-23 16:44:42","TRTEDTM":"2021-02-19 02:07:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"DEATH","DTHDT":"2021-03-29","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":102.28571,"AVALU":"WEEKS","ADTM":"2022-11-08 14:27:52","ADY":716,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-08 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-09 10:39:06","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.43032,"AVALU":"YEARS","ADTM":"2020-02-14 10:39:06","ADY":158,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.58695,"AVALU":"YEARS","ADTM":"2020-04-11 10:39:06","ADY":215,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":58.42857,"AVALU":"WEEKS","ADTM":"2020-10-21 12:52:57","ADY":409,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-60","SUBJID":"id-60","SITEID":"CHN-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.21027,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-09 10:39:06","TRTEDTM":"2021-09-08 22:17:30","EOSSTT":"COMPLETED","EOSDT":"2021-09-08","EOSDY":731,"LSTALVDT":"2021-10-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":64.71429,"AVALU":"WEEKS","ADTM":"2020-12-04 14:33:19","ADY":453,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01781,"AVALU":"YEARS","ADTM":"2019-10-23 23:05:06","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-16 23:05:06","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.72418,"AVALU":"YEARS","ADTM":"2020-07-07 23:05:06","ADY":265,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":91.14286,"AVALU":"WEEKS","ADTM":"2021-07-14 09:11:33","ADY":638,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-63","SUBJID":"id-63","SITEID":"CHN-11","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.80483,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-16 23:05:06","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":22.42857,"AVALU":"WEEKS","ADTM":"2020-03-20 21:05:26","ADY":157,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08591,"AVALU":"YEARS","ADTM":"2020-04-10 05:10:44","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06751,"AVALU":"YEARS","ADTM":"2020-04-03 05:10:44","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-10 05:10:44","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":72,"AVALU":"WEEKS","ADTM":"2021-07-25 05:26:06","ADY":504,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-75","SUBJID":"id-75","SITEID":"CHN-11","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.61263,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-06","TRTSDTM":"2020-03-09 05:10:44","TRTEDTM":"2022-03-09 16:49:08","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":16.14286,"AVALU":"WEEKS","ADTM":"2020-06-29 03:54:50","ADY":113,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-22 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-23 23:35:34","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-23 23:35:34","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.13543,"AVALU":"YEARS","ADTM":"2019-07-11 23:35:34","ADY":50,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-05-22 23:35:34","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-88","SUBJID":"id-88","SITEID":"CHN-11","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.36809,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-22","TRTSDTM":"2019-05-22 23:35:34","TRTEDTM":"2021-05-22 11:13:58","EOSSTT":"COMPLETED","EOSDT":"2021-05-22","EOSDY":731,"LSTALVDT":"2021-06-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":36.14286,"AVALU":"WEEKS","ADTM":"2020-01-29 23:46:28","ADY":253,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.13347,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":414,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.22893,"AVALU":"YEARS","ADTM":"2020-03-24 21:18:57","ADY":84,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10022,"AVALU":"YEARS","ADTM":"2020-02-06 21:18:57","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07495,"AVALU":"YEARS","ADTM":"2020-01-28 21:18:57","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":61.57143,"AVALU":"WEEKS","ADTM":"2021-03-05 22:18:15","ADY":431,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-90","SUBJID":"id-90","SITEID":"CHN-11","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.2096,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 21:18:57","TRTEDTM":"2021-02-16 22:01:39","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":414,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60,"AVALU":"WEEKS","ADTM":"2021-02-22 02:50:06","ADY":420,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-30 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-31 13:56:08","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06212,"AVALU":"YEARS","ADTM":"2020-06-21 13:56:08","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05087,"AVALU":"YEARS","ADTM":"2020-06-17 13:56:08","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":51.42857,"AVALU":"WEEKS","ADTM":"2021-05-23 21:49:48","ADY":360,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-11-id-91","SUBJID":"id-91","SITEID":"CHN-11","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-11","INVNAM":"Dr. CHN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.001,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-28","TRTSDTM":"2020-05-29 13:56:08","TRTEDTM":"2022-05-30 01:34:32","EOSSTT":"COMPLETED","EOSDT":"2022-05-30","EOSDY":731,"LSTALVDT":"2022-06-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-05-29 13:56:08","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-21 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.14624,"AVALU":"YEARS","ADTM":"2020-08-13 19:14:39","ADY":54,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07557,"AVALU":"YEARS","ADTM":"2020-07-18 19:14:39","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04199,"AVALU":"YEARS","ADTM":"2020-07-06 19:14:39","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":101.28571,"AVALU":"WEEKS","ADTM":"2022-05-29 14:10:10","ADY":709,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-255","SUBJID":"id-255","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.49031,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-16","TRTSDTM":"2020-06-20 19:14:39","TRTEDTM":"2022-06-21 06:53:03","EOSSTT":"COMPLETED","EOSDT":"2022-06-21","EOSDY":731,"LSTALVDT":"2022-07-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":62.28571,"AVALU":"WEEKS","ADTM":"2021-08-29 20:57:03","ADY":436,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-01 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-02 06:27:49","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09455,"AVALU":"YEARS","ADTM":"2020-04-05 06:27:49","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.19206,"AVALU":"YEARS","ADTM":"2020-05-11 06:27:49","ADY":71,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":59.85714,"AVALU":"WEEKS","ADTM":"2021-04-23 17:06:45","ADY":419,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-258","SUBJID":"id-258","SITEID":"CHN-12","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":1.71573,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-03-01","TRTSDTM":"2020-03-01 06:27:49","TRTEDTM":"2022-03-01 18:06:13","EOSSTT":"COMPLETED","EOSDT":"2022-03-01","EOSDY":731,"LSTALVDT":"2022-03-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":77.57143,"AVALU":"WEEKS","ADTM":"2021-08-25 15:01:58","ADY":543,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.31143,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":479,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.02635,"AVALU":"YEARS","ADTM":"2019-11-08 08:07:07","ADY":10,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0114,"AVALU":"YEARS","ADTM":"2019-11-03 08:07:07","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.44518,"AVALU":"YEARS","ADTM":"2020-04-09 08:07:07","ADY":163,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":80.14286,"AVALU":"WEEKS","ADTM":"2021-05-11 22:47:27","ADY":561,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-266","SUBJID":"id-266","SITEID":"CHN-12","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":11.29142,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-27","TRTSDTM":"2019-10-29 08:07:07","TRTEDTM":"2021-02-18 08:14:12","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":479,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":84.28571,"AVALU":"WEEKS","ADTM":"2021-06-09 04:59:35","ADY":590,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.3833,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":140,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.0411,"AVALU":"YEARS","ADTM":"2020-10-13 19:00:51","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03656,"AVALU":"YEARS","ADTM":"2020-10-11 19:00:51","ADY":14,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24017,"AVALU":"YEARS","ADTM":"2020-12-24 19:00:51","ADY":88,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":85,"AVALU":"WEEKS","ADTM":"2022-05-14 21:46:15","ADY":595,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-285","SUBJID":"id-285","SITEID":"CHN-12","AGE":39,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.79676,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-24","TRTSDTM":"2020-09-27 19:00:51","TRTEDTM":"2021-02-13 22:47:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":140,"DCSREAS":"DEATH","DTHDT":"2021-03-13","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":104,"AVALU":"WEEKS","ADTM":"2022-09-24 12:14:53","ADY":728,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-10 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-11 10:43:16","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.05797,"AVALU":"YEARS","ADTM":"2020-11-01 10:43:16","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.41996,"AVALU":"YEARS","ADTM":"2021-03-13 10:43:16","ADY":154,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-10-10 22:13:40","ADY":1,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-294","SUBJID":"id-294","SITEID":"CHN-12","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.67351,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-09","TRTSDTM":"2020-10-10 10:43:16","TRTEDTM":"2022-10-10 22:21:40","EOSSTT":"COMPLETED","EOSDT":"2022-10-10","EOSDY":731,"LSTALVDT":"2022-10-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":7.28571,"AVALU":"WEEKS","ADTM":"2020-11-29 07:41:37","ADY":51,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.62902,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":595,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.19966,"AVALU":"YEARS","ADTM":"2019-09-15 15:02:13","ADY":73,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06761,"AVALU":"YEARS","ADTM":"2019-07-29 15:02:13","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00334,"AVALU":"YEARS","ADTM":"2019-07-06 15:02:13","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":31.14286,"AVALU":"WEEKS","ADTM":"2020-02-06 10:57:17","ADY":218,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-322","SUBJID":"id-322","SITEID":"CHN-12","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.28899,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-01","TRTSDTM":"2019-07-04 15:02:13","TRTEDTM":"2021-02-17 15:03:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":595,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":3,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":30.71429,"AVALU":"WEEKS","ADTM":"2020-02-03 17:45:04","ADY":215,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-20 10:29:19","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-20 10:29:19","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-20 10:29:19","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-09-20 10:29:19","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-396","SUBJID":"id-396","SITEID":"CHN-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.15746,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-19","TRTSDTM":"2019-09-20 10:29:19","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":13.14286,"AVALU":"WEEKS","ADTM":"2019-12-20 01:29:48","ADY":92,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-12 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-13 01:02:25","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-13 01:02:25","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1178,"AVALU":"YEARS","ADTM":"2019-11-26 01:02:25","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":88,"AVALU":"WEEKS","ADTM":"2021-06-19 04:11:48","ADY":616,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-12-id-57","SUBJID":"id-57","SITEID":"CHN-12","AGE":45,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-12","INVNAM":"Dr. CHN-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.92748,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 01:02:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":56.71429,"AVALU":"WEEKS","ADTM":"2020-11-12 22:44:36","ADY":397,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-22 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-23 06:05:22","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18429,"AVALU":"YEARS","ADTM":"2019-05-30 06:05:22","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24105,"AVALU":"YEARS","ADTM":"2019-06-20 06:05:22","ADY":89,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3,"AVALU":"WEEKS","ADTM":"2019-04-12 15:30:05","ADY":21,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-102","SUBJID":"id-102","SITEID":"CHN-13","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.04895,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-23 06:05:22","TRTEDTM":"2021-03-22 17:43:46","EOSSTT":"COMPLETED","EOSDT":"2021-03-22","EOSDY":731,"LSTALVDT":"2021-04-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":87.85714,"AVALU":"WEEKS","ADTM":"2020-11-26 06:02:42","ADY":615,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-01 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.24385,"AVALU":"YEARS","ADTM":"2020-09-28 22:25:42","ADY":90,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18758,"AVALU":"YEARS","ADTM":"2020-09-07 22:25:42","ADY":69,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.2556,"AVALU":"YEARS","ADTM":"2020-10-02 22:25:42","ADY":94,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17,"AVALU":"WEEKS","ADTM":"2020-10-26 12:53:17","ADY":119,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-166","SUBJID":"id-166","SITEID":"CHN-13","AGE":43,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":10.57965,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-30","TRTSDTM":"2020-06-30 22:25:42","TRTEDTM":"2022-07-01 10:04:06","EOSSTT":"COMPLETED","EOSDT":"2022-07-01","EOSDY":731,"LSTALVDT":"2022-07-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.28571,"AVALU":"WEEKS","ADTM":"2022-01-26 10:05:44","ADY":576,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-12 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.0778,"AVALU":"YEARS","ADTM":"2019-11-11 05:33:16","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.3385,"AVALU":"YEARS","ADTM":"2020-02-14 05:33:16","ADY":124,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06294,"AVALU":"YEARS","ADTM":"2019-11-05 05:33:16","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":1.14286,"AVALU":"WEEKS","ADTM":"2019-10-20 15:09:11","ADY":8,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-19","SUBJID":"id-19","SITEID":"CHN-13","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.95167,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-10","TRTSDTM":"2019-10-13 05:33:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.28571,"AVALU":"WEEKS","ADTM":"2021-05-10 03:08:48","ADY":576,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-07 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.22059,"AVALU":"YEARS","ADTM":"2021-01-26 22:19:13","ADY":81,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.81382,"AVALU":"YEARS","ADTM":"2021-08-31 22:19:13","ADY":298,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.09773,"AVALU":"YEARS","ADTM":"2021-12-12 22:19:13","ADY":401,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":32.28571,"AVALU":"WEEKS","ADTM":"2021-06-19 22:35:22","ADY":226,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-239","SUBJID":"id-239","SITEID":"CHN-13","AGE":58,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.44252,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-05","TRTSDTM":"2020-11-06 22:19:13","TRTEDTM":"2022-11-07 09:57:37","EOSSTT":"COMPLETED","EOSDT":"2022-11-07","EOSDY":731,"LSTALVDT":"2022-11-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":84.71429,"AVALU":"WEEKS","ADTM":"2022-06-21 15:58:00","ADY":593,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-08 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00103,"AVALU":"YEARS","ADTM":"2019-04-09 12:55:05","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-09 12:55:05","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.2282,"AVALU":"YEARS","ADTM":"2019-07-01 12:55:05","ADY":84,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":1.14286,"AVALU":"WEEKS","ADTM":"2019-04-15 23:14:10","ADY":8,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-240","SUBJID":"id-240","SITEID":"CHN-13","AGE":42,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.49929,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-06","TRTSDTM":"2019-04-08 12:55:05","TRTEDTM":"2021-04-08 00:33:29","EOSSTT":"COMPLETED","EOSDT":"2021-04-08","EOSDY":731,"LSTALVDT":"2021-04-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":10.28571,"AVALU":"WEEKS","ADTM":"2019-06-18 07:03:19","ADY":72,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.97741,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":357,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.87502,"AVALU":"YEARS","ADTM":"2021-01-10 05:19:41","ADY":320,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.97741,"AVALU":"YEARS","ADTM":"2021-02-16 05:19:41","ADY":357,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0274,"AVALU":"YEARS","ADTM":"2020-03-07 05:19:41","ADY":11,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":97.28571,"AVALU":"WEEKS","ADTM":"2022-01-05 22:38:15","ADY":681,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-249","SUBJID":"id-249","SITEID":"CHN-13","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.78004,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-24","TRTSDTM":"2020-02-25 05:19:41","TRTEDTM":"2021-02-15 13:01:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":357,"DCSREAS":"DEATH","DTHDT":"2021-04-05","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":63.14286,"AVALU":"WEEKS","ADTM":"2021-05-11 15:13:19","ADY":442,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.50308,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":549,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.32807,"AVALU":"YEARS","ADTM":"2019-12-15 15:04:05","ADY":120,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.50308,"AVALU":"YEARS","ADTM":"2021-02-16 15:04:05","ADY":549,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.41575,"AVALU":"YEARS","ADTM":"2020-01-16 15:04:05","ADY":152,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":32.28571,"AVALU":"WEEKS","ADTM":"2020-03-29 18:01:17","ADY":226,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-270","SUBJID":"id-270","SITEID":"CHN-13","AGE":39,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":15.11156,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-08-13","TRTSDTM":"2019-08-17 15:04:05","TRTEDTM":"2021-02-15 18:02:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":549,"DCSREAS":"DEATH","DTHDT":"2021-02-21","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-21","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":86.71429,"AVALU":"WEEKS","ADTM":"2021-04-14 07:40:32","ADY":607,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-22 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05807,"AVALU":"YEARS","ADTM":"2020-03-16 10:37:01","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-23 10:37:01","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.87846,"AVALU":"YEARS","ADTM":"2021-01-09 10:37:01","ADY":321,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-02-23 10:37:01","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-13-id-304","SUBJID":"id-304","SITEID":"CHN-13","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-13","INVNAM":"Dr. CHN-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.79003,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-21","TRTSDTM":"2020-02-23 10:37:01","TRTEDTM":"2022-02-22 22:15:25","EOSSTT":"COMPLETED","EOSDT":"2022-02-22","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60.28571,"AVALU":"WEEKS","ADTM":"2021-04-19 23:02:06","ADY":422,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.78782,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":653,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.12885,"AVALU":"YEARS","ADTM":"2019-06-24 11:57:09","ADY":48,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.78782,"AVALU":"YEARS","ADTM":"2021-02-18 11:57:09","ADY":653,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11845,"AVALU":"YEARS","ADTM":"2019-06-20 11:57:09","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":102.28571,"AVALU":"WEEKS","ADTM":"2021-04-21 17:42:28","ADY":716,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-1","SUBJID":"id-1","SITEID":"CHN-14","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.72251,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-06","TRTSDTM":"2019-05-07 11:57:09","TRTEDTM":"2021-02-17 23:50:21","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-07","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":18,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-05-07 11:57:09","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.28405,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":469,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.81807,"AVALU":"YEARS","ADTM":"2020-08-27 23:58:05","ADY":299,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10842,"AVALU":"YEARS","ADTM":"2019-12-12 23:58:05","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.17677,"AVALU":"YEARS","ADTM":"2020-01-06 23:58:05","ADY":65,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":41.28571,"AVALU":"WEEKS","ADTM":"2020-08-16 18:43:35","ADY":289,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-103","SUBJID":"id-103","SITEID":"CHN-14","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.7478,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-11-02 23:58:05","TRTEDTM":"2021-02-12 05:47:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":468,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":50,"AVALU":"WEEKS","ADTM":"2020-10-16 21:49:50","ADY":350,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-07 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-08 11:20:52","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-08 11:20:52","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-08 11:20:52","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":55.71429,"AVALU":"WEEKS","ADTM":"2021-08-31 09:17:31","ADY":390,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-143","SUBJID":"id-143","SITEID":"CHN-14","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.17717,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-06","TRTSDTM":"2020-08-07 11:20:52","TRTEDTM":"2022-08-07 22:59:16","EOSSTT":"COMPLETED","EOSDT":"2022-08-07","EOSDY":731,"LSTALVDT":"2022-08-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":12.85714,"AVALU":"WEEKS","ADTM":"2020-11-04 11:31:35","ADY":90,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-11 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06166,"AVALU":"YEARS","ADTM":"2019-10-05 02:33:33","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.088,"AVALU":"YEARS","ADTM":"2019-10-15 02:33:33","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03092,"AVALU":"YEARS","ADTM":"2019-09-24 02:33:33","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":58.57143,"AVALU":"WEEKS","ADTM":"2020-10-25 10:24:34","ADY":410,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-161","SUBJID":"id-161","SITEID":"CHN-14","AGE":33,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.56375,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-09","TRTSDTM":"2019-09-12 02:33:33","TRTEDTM":"2021-09-11 14:11:57","EOSSTT":"COMPLETED","EOSDT":"2021-09-11","EOSDY":731,"LSTALVDT":"2021-09-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":66.71429,"AVALU":"WEEKS","ADTM":"2020-12-21 06:29:49","ADY":467,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-29 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.23622,"AVALU":"YEARS","ADTM":"2019-08-24 13:16:35","ADY":87,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02604,"AVALU":"YEARS","ADTM":"2019-06-08 13:16:35","ADY":10,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12336,"AVALU":"YEARS","ADTM":"2019-07-14 13:16:35","ADY":46,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":95.85714,"AVALU":"WEEKS","ADTM":"2021-03-29 10:32:22","ADY":671,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-168","SUBJID":"id-168","SITEID":"CHN-14","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.75487,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-25","TRTSDTM":"2019-05-29 13:16:35","TRTEDTM":"2021-05-29 00:54:59","EOSSTT":"COMPLETED","EOSDT":"2021-05-29","EOSDY":731,"LSTALVDT":"2021-06-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":94.71429,"AVALU":"WEEKS","ADTM":"2021-03-21 06:15:16","ADY":663,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10137,"AVALU":"YEARS","ADTM":"2019-11-25 12:35:42","ADY":38,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.04078,"AVALU":"YEARS","ADTM":"2019-11-02 12:35:42","ADY":15,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06596,"AVALU":"YEARS","ADTM":"2019-11-12 12:35:42","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":23,"AVALU":"WEEKS","ADTM":"2020-03-26 18:32:37","ADY":161,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-228","SUBJID":"id-228","SITEID":"CHN-14","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.31115,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-14","TRTSDTM":"2019-10-18 12:35:42","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":39.71429,"AVALU":"WEEKS","ADTM":"2020-07-21 04:21:11","ADY":278,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.07392,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":27,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.0406,"AVALU":"YEARS","ADTM":"2021-02-07 21:26:33","ADY":15,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07382,"AVALU":"YEARS","ADTM":"2021-02-19 21:26:33","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02791,"AVALU":"YEARS","ADTM":"2021-02-03 21:26:33","ADY":11,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":53,"AVALU":"WEEKS","ADTM":"2022-01-28 15:46:25","ADY":371,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-305","SUBJID":"id-305","SITEID":"CHN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.83617,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-20","TRTSDTM":"2021-01-23 21:26:33","TRTEDTM":"2021-02-18 17:02:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":26,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":20,"AVALU":"WEEKS","ADTM":"2021-06-11 03:16:15","ADY":140,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-28 06:34:40","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09068,"AVALU":"YEARS","ADTM":"2020-04-30 06:34:40","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.25343,"AVALU":"YEARS","ADTM":"2020-06-28 06:34:40","ADY":93,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":8.42857,"AVALU":"WEEKS","ADTM":"2020-05-24 22:45:43","ADY":59,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-375","SUBJID":"id-375","SITEID":"CHN-14","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.09912,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-27 06:34:40","TRTEDTM":"2022-03-27 18:13:04","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":100.42857,"AVALU":"WEEKS","ADTM":"2022-02-27 23:07:04","ADY":703,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.16386,"AVALU":"YEARS","ADTM":"2019-12-09 17:57:44","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-10 17:57:44","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16575,"AVALU":"YEARS","ADTM":"2019-12-10 17:57:44","ADY":61,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":87.57143,"AVALU":"WEEKS","ADTM":"2021-06-13 10:57:18","ADY":613,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-14-id-56","SUBJID":"id-56","SITEID":"CHN-14","AGE":25,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-14","INVNAM":"Dr. CHN-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.51563,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-07","TRTSDTM":"2019-10-10 17:57:44","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":9,"AVALU":"WEEKS","ADTM":"2019-12-11 22:03:58","ADY":63,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-28 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00936,"AVALU":"YEARS","ADTM":"2019-10-03 11:27:48","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11115,"AVALU":"YEARS","ADTM":"2019-11-09 11:27:48","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.30588,"AVALU":"YEARS","ADTM":"2020-01-19 11:27:48","ADY":112,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":71.85714,"AVALU":"WEEKS","ADTM":"2021-02-12 04:44:18","ADY":503,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-14","SUBJID":"id-14","SITEID":"CHN-15","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.02692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-29","TRTSDTM":"2019-09-29 11:27:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":29.14286,"AVALU":"WEEKS","ADTM":"2020-04-19 08:21:04","ADY":204,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.9603,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":716,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":11} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.30422,"AVALU":"YEARS","ADTM":"2019-06-25 15:23:44","ADY":112,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11597,"AVALU":"YEARS","ADTM":"2019-04-17 15:23:44","ADY":43,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.31852,"AVALU":"YEARS","ADTM":"2019-06-30 15:23:44","ADY":117,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":8.71429,"AVALU":"WEEKS","ADTM":"2019-05-04 18:09:05","ADY":61,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-201","SUBJID":"id-201","SITEID":"CHN-15","AGE":49,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.9068,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-05","TRTSDTM":"2019-03-05 15:23:44","TRTEDTM":"2021-02-17 20:23:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":716,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.85714,"AVALU":"WEEKS","ADTM":"2019-07-14 07:18:17","ADY":132,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.88912,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":690,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":12} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04949,"AVALU":"YEARS","ADTM":"2019-04-17 02:25:55","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.30921,"AVALU":"YEARS","ADTM":"2019-07-20 02:25:55","ADY":113,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18562,"AVALU":"YEARS","ADTM":"2019-06-05 02:25:55","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":87.85714,"AVALU":"WEEKS","ADTM":"2020-12-02 08:44:56","ADY":615,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-245","SUBJID":"id-245","SITEID":"CHN-15","AGE":34,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.68285,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-03-25","TRTSDTM":"2019-03-29 02:25:55","TRTEDTM":"2021-02-15 06:10:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":690,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":5,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":4.42857,"AVALU":"WEEKS","ADTM":"2019-04-28 20:48:43","ADY":31,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-25 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-26 09:05:00","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.48541,"AVALU":"YEARS","ADTM":"2019-08-23 09:05:00","ADY":178,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-26 09:05:00","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":101,"AVALU":"WEEKS","ADTM":"2021-02-01 21:38:02","ADY":707,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-262","SUBJID":"id-262","SITEID":"CHN-15","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.05546,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-02-26","TRTSDTM":"2019-02-26 09:05:00","TRTEDTM":"2021-02-25 20:43:24","EOSSTT":"COMPLETED","EOSDT":"2021-02-25","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":5.14286,"AVALU":"WEEKS","ADTM":"2019-04-02 02:16:01","ADY":36,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.24909,"AVALU":"YEARS","ADTM":"2019-12-20 10:18:18","ADY":91,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.05475,"AVALU":"YEARS","ADTM":"2019-10-10 10:18:18","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-20 10:18:18","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":61.57143,"AVALU":"WEEKS","ADTM":"2020-11-23 05:51:43","ADY":431,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-297","SUBJID":"id-297","SITEID":"CHN-15","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":11.93491,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-20","TRTSDTM":"2019-09-20 10:18:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":77.85714,"AVALU":"WEEKS","ADTM":"2021-03-17 19:23:27","ADY":545,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-14 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-15 09:17:20","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-15 09:17:20","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.57552,"AVALU":"YEARS","ADTM":"2020-05-13 09:17:20","ADY":211,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.14286,"AVALU":"WEEKS","ADTM":"2019-11-19 22:17:48","ADY":36,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-15-id-399","SUBJID":"id-399","SITEID":"CHN-15","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-15","INVNAM":"Dr. CHN-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":0.99183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-13","TRTSDTM":"2019-10-15 09:17:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":104.28571,"AVALU":"WEEKS","ADTM":"2021-10-13 18:06:51","ADY":730,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.17454,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":429,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.17454,"AVALU":"YEARS","ADTM":"2021-02-17 09:21:14","ADY":430,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.19612,"AVALU":"YEARS","ADTM":"2020-02-25 09:21:14","ADY":72,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.26014,"AVALU":"YEARS","ADTM":"2020-03-20 09:21:14","ADY":96,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":19.14286,"AVALU":"WEEKS","ADTM":"2020-04-26 05:54:51","ADY":134,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-154","SUBJID":"id-154","SITEID":"CHN-16","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.17155,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-12","TRTSDTM":"2019-12-15 09:21:14","TRTEDTM":"2021-02-15 10:52:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":429,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":33,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":22.85714,"AVALU":"WEEKS","ADTM":"2020-05-22 16:30:04","ADY":160,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.25667,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":459,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.6766,"AVALU":"YEARS","ADTM":"2020-07-24 07:04:52","ADY":248,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.04212,"AVALU":"YEARS","ADTM":"2020-12-04 07:04:52","ADY":381,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20453,"AVALU":"YEARS","ADTM":"2020-02-02 07:04:52","ADY":75,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":21.57143,"AVALU":"WEEKS","ADTM":"2020-04-17 20:40:39","ADY":151,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-241","SUBJID":"id-241","SITEID":"CHN-16","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.53579,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-16","TRTSDTM":"2019-11-19 07:04:52","TRTEDTM":"2021-02-19 02:49:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":458,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":66.28571,"AVALU":"WEEKS","ADTM":"2021-02-24 16:26:40","ADY":464,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-10 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.22769,"AVALU":"YEARS","ADTM":"2021-02-01 15:23:05","ADY":84,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-11 15:23:05","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.35912,"AVALU":"YEARS","ADTM":"2021-03-21 15:23:05","ADY":132,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":100.28571,"AVALU":"WEEKS","ADTM":"2022-10-11 07:47:07","ADY":702,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-302","SUBJID":"id-302","SITEID":"CHN-16","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.79834,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-06","TRTSDTM":"2020-11-09 15:23:05","TRTEDTM":"2022-11-10 03:01:29","EOSSTT":"COMPLETED","EOSDT":"2022-11-10","EOSDY":731,"LSTALVDT":"2022-12-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.42857,"AVALU":"WEEKS","ADTM":"2021-01-06 02:43:49","ADY":59,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00411,"AVALU":"YEARS","ADTM":"2019-12-27 20:01:20","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-25 20:01:20","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01632,"AVALU":"YEARS","ADTM":"2019-12-31 20:01:20","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-12-25 20:01:20","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-323","SUBJID":"id-323","SITEID":"CHN-16","AGE":51,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.94449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-25 20:01:20","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":80.85714,"AVALU":"WEEKS","ADTM":"2021-07-12 23:41:05","ADY":566,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-02-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":14} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.12412,"AVALU":"YEARS","ADTM":"2021-03-20 09:04:52","ADY":46,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01084,"AVALU":"YEARS","ADTM":"2021-02-06 09:04:52","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.25506,"AVALU":"YEARS","ADTM":"2021-05-07 09:04:52","ADY":94,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":60,"AVALU":"WEEKS","ADTM":"2022-03-28 03:55:06","ADY":420,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-352","SUBJID":"id-352","SITEID":"CHN-16","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.21681,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-30","TRTSDTM":"2021-02-02 09:04:52","TRTEDTM":"2023-02-02 20:43:16","EOSSTT":"COMPLETED","EOSDT":"2023-02-02","EOSDY":731,"LSTALVDT":"2023-02-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2021-02-02 09:04:52","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.99932,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":365,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.99932,"AVALU":"YEARS","ADTM":"2021-02-14 07:25:41","ADY":365,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.99932,"AVALU":"YEARS","ADTM":"2021-02-14 07:25:41","ADY":365,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.32362,"AVALU":"YEARS","ADTM":"2020-06-13 07:25:41","ADY":119,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":67.85714,"AVALU":"WEEKS","ADTM":"2021-06-03 05:28:03","ADY":475,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-16-id-381","SUBJID":"id-381","SITEID":"CHN-16","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-16","INVNAM":"Dr. CHN-16 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.62925,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-14","TRTSDTM":"2020-02-15 07:25:41","TRTEDTM":"2021-02-13 14:59:28","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":365,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":31.42857,"AVALU":"WEEKS","ADTM":"2020-09-21 00:14:44","ADY":220,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-18 00:44:06","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.17294,"AVALU":"YEARS","ADTM":"2021-02-19 00:44:06","ADY":64,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04672,"AVALU":"YEARS","ADTM":"2021-01-04 00:44:06","ADY":18,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":29.28571,"AVALU":"WEEKS","ADTM":"2021-07-09 05:30:03","ADY":205,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-10","SUBJID":"id-10","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.58058,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-12-17","TRTSDTM":"2020-12-17 00:44:06","TRTEDTM":"2022-12-17 12:22:30","EOSSTT":"COMPLETED","EOSDT":"2022-12-17","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-12-17 00:44:06","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.27652,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":101,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.13125,"AVALU":"YEARS","ADTM":"2020-12-29 01:01:23","ADY":48,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.05673,"AVALU":"YEARS","ADTM":"2020-12-02 01:01:23","ADY":21,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03264,"AVALU":"YEARS","ADTM":"2020-11-23 01:01:23","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":72.14286,"AVALU":"WEEKS","ADTM":"2022-03-30 06:34:05","ADY":505,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-129","SUBJID":"id-129","SITEID":"CHN-17","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.12912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-08","TRTSDTM":"2020-11-11 01:01:23","TRTEDTM":"2021-02-19 02:56:34","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":101,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":36,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":17.71429,"AVALU":"WEEKS","ADTM":"2021-03-14 10:22:12","ADY":124,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":11} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10968,"AVALU":"YEARS","ADTM":"2019-10-29 07:49:56","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.70228,"AVALU":"YEARS","ADTM":"2020-06-01 07:49:56","ADY":257,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05259,"AVALU":"YEARS","ADTM":"2019-10-08 07:49:56","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68.85714,"AVALU":"WEEKS","ADTM":"2021-01-11 00:30:11","ADY":482,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-182","SUBJID":"id-182","SITEID":"CHN-17","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.65524,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-17","TRTSDTM":"2019-09-18 07:49:56","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72.28571,"AVALU":"WEEKS","ADTM":"2021-02-04 11:44:46","ADY":506,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.49135,"AVALU":"YEARS","ADTM":"2021-06-14 10:53:53","ADY":180,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-17 10:53:53","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01214,"AVALU":"YEARS","ADTM":"2020-12-21 10:53:53","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":77,"AVALU":"WEEKS","ADTM":"2022-06-07 18:44:30","ADY":539,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-209","SUBJID":"id-209","SITEID":"CHN-17","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":1.64011,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-14","TRTSDTM":"2020-12-16 10:53:53","TRTEDTM":"2022-12-16 22:32:17","EOSSTT":"COMPLETED","EOSDT":"2022-12-16","EOSDY":731,"LSTALVDT":"2022-12-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72.28571,"AVALU":"WEEKS","ADTM":"2022-05-05 10:03:17","ADY":506,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-27 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.37923,"AVALU":"YEARS","ADTM":"2019-09-13 14:56:16","ADY":139,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03243,"AVALU":"YEARS","ADTM":"2019-05-09 14:56:16","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-28 14:56:16","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":7.57143,"AVALU":"WEEKS","ADTM":"2019-06-18 00:24:17","ADY":53,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-309","SUBJID":"id-309","SITEID":"CHN-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.34396,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-27","TRTSDTM":"2019-04-27 14:56:16","TRTEDTM":"2021-04-27 02:34:40","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":97.71429,"AVALU":"WEEKS","ADTM":"2021-03-10 13:33:57","ADY":684,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.62735,"AVALU":"YEARS","ADTM":"2020-07-04 06:49:48","ADY":230,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02293,"AVALU":"YEARS","ADTM":"2019-11-26 06:49:48","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06231,"AVALU":"YEARS","ADTM":"2019-12-10 06:49:48","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":84,"AVALU":"WEEKS","ADTM":"2021-06-26 11:57:23","ADY":588,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-31","SUBJID":"id-31","SITEID":"CHN-17","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.47905,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-15","TRTSDTM":"2019-11-17 06:49:48","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":100.42857,"AVALU":"WEEKS","ADTM":"2021-10-19 21:31:34","ADY":703,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-05-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08428,"AVALU":"YEARS","ADTM":"2019-06-03 06:17:28","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07482,"AVALU":"YEARS","ADTM":"2019-05-31 06:17:28","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.47137,"AVALU":"YEARS","ADTM":"2019-10-23 06:17:28","ADY":173,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":29,"AVALU":"WEEKS","ADTM":"2019-11-21 08:59:00","ADY":203,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-48","SUBJID":"id-48","SITEID":"CHN-17","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":7.25469,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-04-29","TRTSDTM":"2019-05-03 06:17:28","TRTEDTM":"2021-05-02 17:55:52","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":53.85714,"AVALU":"WEEKS","ADTM":"2020-05-13 09:55:27","ADY":377,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-07 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01584,"AVALU":"YEARS","ADTM":"2021-01-13 03:32:32","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20599,"AVALU":"YEARS","ADTM":"2021-03-24 03:32:32","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.36842,"AVALU":"YEARS","ADTM":"2021-05-22 03:32:32","ADY":135,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":41.14286,"AVALU":"WEEKS","ADTM":"2021-10-21 08:28:20","ADY":288,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-5","SUBJID":"id-5","SITEID":"CHN-17","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.86288,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-04","TRTSDTM":"2021-01-07 03:32:32","TRTEDTM":"2023-01-07 15:10:56","EOSSTT":"COMPLETED","EOSDT":"2023-01-07","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":86.71429,"AVALU":"WEEKS","ADTM":"2022-09-05 23:38:40","ADY":607,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.64819,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":602,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.56243,"AVALU":"YEARS","ADTM":"2020-01-21 23:23:38","ADY":206,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.21954,"AVALU":"YEARS","ADTM":"2019-09-18 23:23:38","ADY":81,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.62712,"AVALU":"YEARS","ADTM":"2020-02-14 23:23:38","ADY":230,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":28.28571,"AVALU":"WEEKS","ADTM":"2020-01-12 14:36:31","ADY":198,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-66","SUBJID":"id-66","SITEID":"CHN-17","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.83802,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-06-27","TRTSDTM":"2019-06-29 23:23:38","TRTEDTM":"2021-02-19 06:56:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":601,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":28.28571,"AVALU":"WEEKS","ADTM":"2020-01-12 13:07:01","ADY":198,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.90007,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":694,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11468,"AVALU":"YEARS","ADTM":"2019-05-05 10:20:07","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.90007,"AVALU":"YEARS","ADTM":"2021-02-15 10:20:07","ADY":694,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.90007,"AVALU":"YEARS","ADTM":"2021-02-15 10:20:07","ADY":694,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-03-24 10:20:07","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-84","SUBJID":"id-84","SITEID":"CHN-17","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":6.61367,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-23","TRTSDTM":"2019-03-24 10:20:07","TRTEDTM":"2021-02-14 20:25:44","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":694,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":92.28571,"AVALU":"WEEKS","ADTM":"2020-12-28 04:19:19","ADY":646,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-02 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.28128,"AVALU":"YEARS","ADTM":"2020-06-12 22:55:01","ADY":103,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11383,"AVALU":"YEARS","ADTM":"2020-04-12 22:55:01","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.37124,"AVALU":"YEARS","ADTM":"2020-07-15 22:55:01","ADY":136,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":11.28571,"AVALU":"WEEKS","ADTM":"2020-05-18 12:12:20","ADY":79,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-17-id-92","SUBJID":"id-92","SITEID":"CHN-17","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-17","INVNAM":"Dr. CHN-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.8508,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-02-28","TRTSDTM":"2020-03-01 22:55:01","TRTEDTM":"2022-03-02 10:33:25","EOSSTT":"COMPLETED","EOSDT":"2022-03-02","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":38.42857,"AVALU":"WEEKS","ADTM":"2020-11-24 22:12:47","ADY":269,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-11 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08285,"AVALU":"YEARS","ADTM":"2021-01-11 01:47:36","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02722,"AVALU":"YEARS","ADTM":"2020-12-21 01:47:36","ADY":10,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05174,"AVALU":"YEARS","ADTM":"2020-12-30 01:47:36","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":39.71429,"AVALU":"WEEKS","ADTM":"2021-09-14 16:57:49","ADY":278,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-106","SUBJID":"id-106","SITEID":"CHN-18","AGE":30,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.04956,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-08","TRTSDTM":"2020-12-11 01:47:36","TRTEDTM":"2022-12-11 13:26:00","EOSSTT":"COMPLETED","EOSDT":"2022-12-11","EOSDY":731,"LSTALVDT":"2022-12-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-12-11 01:47:36","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-20 08:25:51","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.38908,"AVALU":"YEARS","ADTM":"2020-06-11 08:25:51","ADY":143,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06003,"AVALU":"YEARS","ADTM":"2020-02-11 08:25:51","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3,"AVALU":"WEEKS","ADTM":"2020-02-09 14:39:57","ADY":21,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-170","SUBJID":"id-170","SITEID":"CHN-18","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":12.94197,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-20 08:25:51","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":19.57143,"AVALU":"WEEKS","ADTM":"2020-06-04 16:15:24","ADY":137,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-25 15:22:39","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-25 15:22:39","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.542,"AVALU":"YEARS","ADTM":"2020-04-10 15:22:39","ADY":198,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":103,"AVALU":"WEEKS","ADTM":"2021-09-14 05:28:10","ADY":721,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-18-id-51","SUBJID":"id-51","SITEID":"CHN-18","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-18","INVNAM":"Dr. CHN-18 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.95289,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:22:39","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.71429,"AVALU":"WEEKS","ADTM":"2020-02-02 06:01:38","ADY":131,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.84873,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":310,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.84873,"AVALU":"YEARS","ADTM":"2021-02-13 11:36:38","ADY":310,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.36507,"AVALU":"YEARS","ADTM":"2020-08-21 11:36:38","ADY":134,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.17118,"AVALU":"YEARS","ADTM":"2020-06-11 11:36:38","ADY":63,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.28571,"AVALU":"WEEKS","ADTM":"2020-05-15 18:47:09","ADY":37,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-118","SUBJID":"id-118","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.22229,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-09 11:36:38","TRTEDTM":"2021-02-12 07:38:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":309,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":101.71429,"AVALU":"WEEKS","ADTM":"2022-03-21 23:51:15","ADY":712,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.12252,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":410,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00758,"AVALU":"YEARS","ADTM":"2020-01-10 08:17:12","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.27625,"AVALU":"YEARS","ADTM":"2020-04-17 08:17:12","ADY":101,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18622,"AVALU":"YEARS","ADTM":"2020-03-16 08:17:12","ADY":69,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":28,"AVALU":"WEEKS","ADTM":"2020-07-20 03:10:41","ADY":196,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-149","SUBJID":"id-149","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":9.64074,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-03","TRTSDTM":"2020-01-07 08:17:12","TRTEDTM":"2021-02-19 11:36:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":410,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-01-07 08:17:12","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.08761,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":32,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08761,"AVALU":"YEARS","ADTM":"2021-02-16 23:17:27","ADY":32,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.04049,"AVALU":"YEARS","ADTM":"2021-01-30 23:17:27","ADY":15,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05277,"AVALU":"YEARS","ADTM":"2021-02-04 23:17:27","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":92.85714,"AVALU":"WEEKS","ADTM":"2022-10-26 23:12:25","ADY":650,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-22","SUBJID":"id-22","SITEID":"CHN-2","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.69016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-14","TRTSDTM":"2021-01-15 23:17:27","TRTEDTM":"2021-02-15 04:16:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":31,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":89.14286,"AVALU":"WEEKS","ADTM":"2022-09-30 23:51:18","ADY":624,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-18 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-19 10:03:46","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.26715,"AVALU":"YEARS","ADTM":"2021-02-24 10:03:46","ADY":98,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-19 10:03:46","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":83.71429,"AVALU":"WEEKS","ADTM":"2022-06-26 08:43:37","ADY":586,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-223","SUBJID":"id-223","SITEID":"CHN-2","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.62508,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-15","TRTSDTM":"2020-11-18 10:03:46","TRTEDTM":"2022-11-18 21:42:10","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72.42857,"AVALU":"WEEKS","ADTM":"2022-04-08 19:46:22","ADY":507,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.11157,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":406,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05757,"AVALU":"YEARS","ADTM":"2020-02-02 03:25:00","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.11157,"AVALU":"YEARS","ADTM":"2021-02-20 03:25:00","ADY":406,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.11157,"AVALU":"YEARS","ADTM":"2021-02-20 03:25:00","ADY":406,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":29.71429,"AVALU":"WEEKS","ADTM":"2020-08-05 09:39:48","ADY":208,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-272","SUBJID":"id-272","SITEID":"CHN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":7.17023,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-08","TRTSDTM":"2020-01-11 03:25:00","TRTEDTM":"2021-02-19 05:06:48","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":406,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.85714,"AVALU":"WEEKS","ADTM":"2020-03-12 03:27:05","ADY":62,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-13 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.28128,"AVALU":"YEARS","ADTM":"2020-01-25 16:50:28","ADY":103,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.144,"AVALU":"YEARS","ADTM":"2019-12-06 16:50:28","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07731,"AVALU":"YEARS","ADTM":"2019-11-12 16:50:28","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":22.57143,"AVALU":"WEEKS","ADTM":"2020-03-19 10:06:46","ADY":158,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-274","SUBJID":"id-274","SITEID":"CHN-2","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.58528,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-10","TRTSDTM":"2019-10-14 16:50:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-10-14 16:50:28","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-14 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07359,"AVALU":"YEARS","ADTM":"2020-10-10 23:16:17","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.82447,"AVALU":"YEARS","ADTM":"2021-07-12 23:16:17","ADY":302,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00287,"AVALU":"YEARS","ADTM":"2020-09-15 23:16:17","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":32.71429,"AVALU":"WEEKS","ADTM":"2021-04-29 23:27:29","ADY":229,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-284","SUBJID":"id-284","SITEID":"CHN-2","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":8.02225,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-13 23:16:17","TRTEDTM":"2022-09-14 10:54:41","EOSSTT":"COMPLETED","EOSDT":"2022-09-14","EOSDY":731,"LSTALVDT":"2022-10-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":16.28571,"AVALU":"WEEKS","ADTM":"2021-01-04 06:01:03","ADY":114,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.76591,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":645,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.76591,"AVALU":"YEARS","ADTM":"2021-02-19 15:20:52","ADY":645,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.76591,"AVALU":"YEARS","ADTM":"2021-02-19 15:20:52","ADY":645,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.27867,"AVALU":"YEARS","ADTM":"2019-08-26 15:20:52","ADY":102,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":81.57143,"AVALU":"WEEKS","ADTM":"2020-12-06 19:25:36","ADY":571,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-286","SUBJID":"id-286","SITEID":"CHN-2","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.63472,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-16","TRTSDTM":"2019-05-16 15:20:52","TRTEDTM":"2021-02-18 01:29:54","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":644,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":87,"AVALU":"WEEKS","ADTM":"2021-01-13 06:06:45","ADY":609,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.59959,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":219,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.59959,"AVALU":"YEARS","ADTM":"2021-02-14 08:29:27","ADY":219,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.33816,"AVALU":"YEARS","ADTM":"2020-11-11 08:29:27","ADY":124,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.15615,"AVALU":"YEARS","ADTM":"2020-09-06 08:29:27","ADY":58,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":56,"AVALU":"WEEKS","ADTM":"2021-08-05 05:37:19","ADY":392,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-292","SUBJID":"id-292","SITEID":"CHN-2","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":7.87128,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-07","TRTSDTM":"2020-07-10 08:29:27","TRTEDTM":"2021-02-13 23:05:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":219,"DCSREAS":"DEATH","DTHDT":"2021-03-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.14286,"AVALU":"WEEKS","ADTM":"2021-01-08 06:50:29","ADY":183,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":497,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.80077,"AVALU":"YEARS","ADTM":"2020-07-27 07:43:35","ADY":293,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.17173,"AVALU":"YEARS","ADTM":"2020-12-09 07:43:35","ADY":428,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01792,"AVALU":"YEARS","ADTM":"2019-10-15 07:43:35","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":85.85714,"AVALU":"WEEKS","ADTM":"2021-05-30 20:06:13","ADY":601,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-332","SUBJID":"id-332","SITEID":"CHN-2","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.21853,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 07:43:35","TRTEDTM":"2021-02-15 13:18:14","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":28,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.57143,"AVALU":"WEEKS","ADTM":"2020-04-10 10:47:46","ADY":186,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.59343,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":582,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06419,"AVALU":"YEARS","ADTM":"2019-08-10 09:51:50","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20646,"AVALU":"YEARS","ADTM":"2019-10-01 09:51:50","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08005,"AVALU":"YEARS","ADTM":"2019-08-16 09:51:50","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-07-17 09:51:50","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-34","SUBJID":"id-34","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.61602,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-17","TRTSDTM":"2019-07-17 09:51:50","TRTEDTM":"2021-02-17 03:21:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":581,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":56.57143,"AVALU":"WEEKS","ADTM":"2020-08-15 11:50:27","ADY":396,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-05 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-06 23:25:32","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-06 23:25:32","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.67962,"AVALU":"YEARS","ADTM":"2021-01-08 23:25:32","ADY":249,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":30.42857,"AVALU":"WEEKS","ADTM":"2020-12-02 12:19:30","ADY":213,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-342","SUBJID":"id-342","SITEID":"CHN-2","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":6.05374,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-02","TRTSDTM":"2020-05-04 23:25:32","TRTEDTM":"2022-05-05 11:03:56","EOSSTT":"COMPLETED","EOSDT":"2022-05-05","EOSDY":731,"LSTALVDT":"2022-05-21","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":13.57143,"AVALU":"WEEKS","ADTM":"2020-08-06 18:44:48","ADY":95,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-28 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.45031,"AVALU":"YEARS","ADTM":"2020-12-09 18:28:21","ADY":165,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.21426,"AVALU":"YEARS","ADTM":"2020-09-14 18:28:21","ADY":79,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-06-29 18:28:21","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":73.85714,"AVALU":"WEEKS","ADTM":"2021-11-25 09:14:10","ADY":517,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-367","SUBJID":"id-367","SITEID":"CHN-2","AGE":40,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.81441,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-24","TRTSDTM":"2020-06-27 18:28:21","TRTEDTM":"2022-06-28 06:06:45","EOSSTT":"COMPLETED","EOSDT":"2022-06-28","EOSDY":731,"LSTALVDT":"2022-07-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":55.28571,"AVALU":"WEEKS","ADTM":"2021-07-18 11:56:25","ADY":387,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-27 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10488,"AVALU":"YEARS","ADTM":"2019-06-05 18:56:25","ADY":39,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.14328,"AVALU":"YEARS","ADTM":"2019-06-19 18:56:25","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-28 18:56:25","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-04-27 18:56:25","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-395","SUBJID":"id-395","SITEID":"CHN-2","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.4824,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 18:56:25","TRTEDTM":"2021-04-27 06:34:49","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":42.71429,"AVALU":"WEEKS","ADTM":"2020-02-19 01:42:56","ADY":299,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-18 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.72714,"AVALU":"YEARS","ADTM":"2020-07-11 21:37:25","ADY":266,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-19 21:37:25","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07169,"AVALU":"YEARS","ADTM":"2019-11-15 21:37:25","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":8.42857,"AVALU":"WEEKS","ADTM":"2019-12-16 18:23:01","ADY":59,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-398","SUBJID":"id-398","SITEID":"CHN-2","AGE":46,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.3426,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-19 21:37:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":67.14286,"AVALU":"WEEKS","ADTM":"2021-01-30 05:26:51","ADY":470,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-28 03:24:34","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.3641,"AVALU":"YEARS","ADTM":"2020-08-07 03:24:34","ADY":133,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.19589,"AVALU":"YEARS","ADTM":"2020-06-07 03:24:34","ADY":72,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":27.71429,"AVALU":"WEEKS","ADTM":"2020-10-06 12:25:30","ADY":194,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-2-id-98","SUBJID":"id-98","SITEID":"CHN-2","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-2","INVNAM":"Dr. CHN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.0539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-27 03:24:34","TRTEDTM":"2022-03-27 15:02:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-27","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":45.42857,"AVALU":"WEEKS","ADTM":"2021-02-07 07:08:17","ADY":318,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-23 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-24 11:09:18","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-24 11:09:18","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18126,"AVALU":"YEARS","ADTM":"2019-05-02 11:09:18","ADY":67,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":91.14286,"AVALU":"WEEKS","ADTM":"2020-11-22 07:19:37","ADY":638,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-128","SUBJID":"id-128","SITEID":"CHN-3","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":14.42493,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-02-22","TRTSDTM":"2019-02-24 11:09:18","TRTEDTM":"2021-02-23 22:47:42","EOSSTT":"COMPLETED","EOSDT":"2021-02-23","EOSDY":731,"LSTALVDT":"2021-03-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":14.57143,"AVALU":"WEEKS","ADTM":"2019-06-05 15:57:47","ADY":102,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.74743,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":273,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00934,"AVALU":"YEARS","ADTM":"2020-05-24 12:58:32","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.74743,"AVALU":"YEARS","ADTM":"2021-02-17 12:58:32","ADY":273,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.74743,"AVALU":"YEARS","ADTM":"2021-02-17 12:58:32","ADY":273,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":23.14286,"AVALU":"WEEKS","ADTM":"2020-10-28 14:36:51","ADY":162,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-155","SUBJID":"id-155","SITEID":"CHN-3","AGE":35,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.27087,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-17","TRTSDTM":"2020-05-20 12:58:32","TRTEDTM":"2021-02-16 18:10:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":273,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":102.28571,"AVALU":"WEEKS","ADTM":"2022-05-05 13:17:20","ADY":716,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-26 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-27 00:49:02","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.33602,"AVALU":"YEARS","ADTM":"2021-05-29 00:49:02","ADY":123,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08329,"AVALU":"YEARS","ADTM":"2021-02-26 00:49:02","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":35.28571,"AVALU":"WEEKS","ADTM":"2021-09-29 21:43:30","ADY":247,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-193","SUBJID":"id-193","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.46044,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-01-24","TRTSDTM":"2021-01-26 00:49:02","TRTEDTM":"2023-01-26 12:27:26","EOSSTT":"COMPLETED","EOSDT":"2023-01-26","EOSDY":731,"LSTALVDT":"2023-02-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":89.42857,"AVALU":"WEEKS","ADTM":"2022-10-13 23:06:55","ADY":626,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-08 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-09 20:55:23","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.78731,"AVALU":"YEARS","ADTM":"2020-05-22 20:55:23","ADY":288,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12192,"AVALU":"YEARS","ADTM":"2019-09-22 20:55:23","ADY":45,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-08-08 20:55:23","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-204","SUBJID":"id-204","SITEID":"CHN-3","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.68264,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-06","TRTSDTM":"2019-08-08 20:55:23","TRTEDTM":"2021-08-08 08:33:47","EOSSTT":"COMPLETED","EOSDT":"2021-08-08","EOSDY":731,"LSTALVDT":"2021-08-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":12.85714,"AVALU":"WEEKS","ADTM":"2019-11-05 21:26:31","ADY":90,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.54141,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":563,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":12} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10917,"AVALU":"YEARS","ADTM":"2019-09-16 07:13:50","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0961,"AVALU":"YEARS","ADTM":"2019-09-12 07:13:50","ADY":36,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14394,"AVALU":"YEARS","ADTM":"2019-09-29 07:13:50","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":52,"AVALU":"WEEKS","ADTM":"2020-08-04 16:30:21","ADY":364,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-259","SUBJID":"id-259","SITEID":"CHN-3","AGE":27,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.3313,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-08-04","TRTSDTM":"2019-08-07 07:13:50","TRTEDTM":"2021-02-19 10:25:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":563,"DCSREAS":"DEATH","DTHDT":"2021-03-31","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":17.14286,"AVALU":"WEEKS","ADTM":"2019-12-04 03:06:27","ADY":120,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.52019,"AVALU":"YEARS","ADTM":"2021-02-11 00:00:00","ADY":190,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.52019,"AVALU":"YEARS","ADTM":"2021-02-12 02:06:26","ADY":190,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0578,"AVALU":"YEARS","ADTM":"2020-08-28 02:06:26","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11517,"AVALU":"YEARS","ADTM":"2020-09-18 02:06:26","ADY":43,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":19.14286,"AVALU":"WEEKS","ADTM":"2020-12-17 18:23:15","ADY":134,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-271","SUBJID":"id-271","SITEID":"CHN-3","AGE":24,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.80752,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-04","TRTSDTM":"2020-08-06 02:06:26","TRTEDTM":"2021-02-11 23:04:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":190,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":95.14286,"AVALU":"WEEKS","ADTM":"2022-06-02 17:19:26","ADY":666,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-03 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-04 15:53:24","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02179,"AVALU":"YEARS","ADTM":"2020-09-10 15:53:24","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06026,"AVALU":"YEARS","ADTM":"2020-09-25 15:53:24","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":13,"AVALU":"WEEKS","ADTM":"2020-12-01 15:51:33","ADY":91,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-281","SUBJID":"id-281","SITEID":"CHN-3","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.37455,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-08-31","TRTSDTM":"2020-09-02 15:53:24","TRTEDTM":"2022-09-03 03:31:48","EOSSTT":"COMPLETED","EOSDT":"2022-09-03","EOSDY":731,"LSTALVDT":"2022-10-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":61.14286,"AVALU":"WEEKS","ADTM":"2021-11-03 21:59:06","ADY":428,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-04 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06094,"AVALU":"YEARS","ADTM":"2020-01-28 00:56:15","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-05 00:56:15","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-05 00:56:15","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":15.14286,"AVALU":"WEEKS","ADTM":"2020-04-19 09:30:37","ADY":106,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-303","SUBJID":"id-303","SITEID":"CHN-3","AGE":44,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.81708,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-05 00:56:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":41.42857,"AVALU":"WEEKS","ADTM":"2020-10-20 22:18:19","ADY":290,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-12 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.08593,"AVALU":"YEARS","ADTM":"2021-02-13 06:51:47","ADY":397,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.89074,"AVALU":"YEARS","ADTM":"2020-12-04 06:51:47","ADY":326,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0837,"AVALU":"YEARS","ADTM":"2020-02-13 06:51:47","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-01-13 06:51:47","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-333","SUBJID":"id-333","SITEID":"CHN-3","AGE":30,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.72886,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-13 06:51:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":20.28571,"AVALU":"WEEKS","ADTM":"2020-06-02 07:14:28","ADY":142,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.85079,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":676,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.85079,"AVALU":"YEARS","ADTM":"2021-02-15 18:38:59","ADY":676,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.85079,"AVALU":"YEARS","ADTM":"2021-02-15 18:38:59","ADY":676,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.85079,"AVALU":"YEARS","ADTM":"2021-02-15 18:38:59","ADY":676,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":76.42857,"AVALU":"WEEKS","ADTM":"2020-09-26 07:14:25","ADY":535,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-361","SUBJID":"id-361","SITEID":"CHN-3","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.32503,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-11","TRTSDTM":"2019-04-11 18:38:59","TRTEDTM":"2021-02-14 15:34:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":675,"DCSREAS":"DEATH","DTHDT":"2021-03-27","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":41,"LDDTHGR1":">30","LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":91.57143,"AVALU":"WEEKS","ADTM":"2021-01-10 02:39:23","ADY":641,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-10 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-11 22:44:14","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.34069,"AVALU":"YEARS","ADTM":"2021-01-12 22:44:14","ADY":125,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00255,"AVALU":"YEARS","ADTM":"2020-09-10 22:44:14","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":35.57143,"AVALU":"WEEKS","ADTM":"2021-05-15 01:51:15","ADY":249,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-3-id-81","SUBJID":"id-81","SITEID":"CHN-3","AGE":35,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-3","INVNAM":"Dr. CHN-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.81724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 22:44:14","TRTEDTM":"2022-09-10 10:22:38","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":43.57143,"AVALU":"WEEKS","ADTM":"2021-07-10 15:46:45","ADY":305,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.50856,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":551,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.09414,"AVALU":"YEARS","ADTM":"2019-09-22 22:33:55","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.70867,"AVALU":"YEARS","ADTM":"2020-05-03 22:33:55","ADY":259,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24696,"AVALU":"YEARS","ADTM":"2019-11-17 22:33:55","ADY":91,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.28571,"AVALU":"WEEKS","ADTM":"2019-12-16 18:49:35","ADY":121,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-114","SUBJID":"id-114","SITEID":"CHN-4","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.10419,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-16","TRTSDTM":"2019-08-18 22:33:55","TRTEDTM":"2021-02-18 07:16:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":550,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":104.42857,"AVALU":"WEEKS","ADTM":"2021-08-17 14:31:33","ADY":731,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-28 09:32:39","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.30399,"AVALU":"YEARS","ADTM":"2019-07-18 09:32:39","ADY":112,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01203,"AVALU":"YEARS","ADTM":"2019-04-02 09:32:39","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":2.71429,"AVALU":"WEEKS","ADTM":"2019-04-15 00:15:22","ADY":19,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-115","SUBJID":"id-115","SITEID":"CHN-4","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.00519,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-26","TRTSDTM":"2019-03-28 09:32:39","TRTEDTM":"2021-03-27 21:11:03","EOSSTT":"COMPLETED","EOSDT":"2021-03-27","EOSDY":731,"LSTALVDT":"2021-04-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":33.71429,"AVALU":"WEEKS","ADTM":"2019-11-18 15:13:00","ADY":236,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.43458,"AVALU":"YEARS","ADTM":"2020-05-28 07:59:52","ADY":159,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-21 07:59:52","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.3403,"AVALU":"YEARS","ADTM":"2020-04-24 07:59:52","ADY":125,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":74.28571,"AVALU":"WEEKS","ADTM":"2021-05-23 13:34:14","ADY":520,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-122","SUBJID":"id-122","SITEID":"CHN-4","AGE":23,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.85899,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-21","TRTSDTM":"2019-12-21 07:59:52","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":65.42857,"AVALU":"WEEKS","ADTM":"2021-03-22 07:29:26","ADY":458,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-20 11:57:55","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.33348,"AVALU":"YEARS","ADTM":"2019-11-19 11:57:55","ADY":122,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20099,"AVALU":"YEARS","ADTM":"2019-10-02 11:57:55","ADY":74,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":1.28571,"AVALU":"WEEKS","ADTM":"2019-07-28 06:43:56","ADY":9,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-310","SUBJID":"id-310","SITEID":"CHN-4","AGE":36,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.85139,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-20","TRTSDTM":"2019-07-20 11:57:55","TRTEDTM":"2021-07-19 23:36:19","EOSSTT":"COMPLETED","EOSDT":"2021-07-19","EOSDY":731,"LSTALVDT":"2021-08-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.85714,"AVALU":"WEEKS","ADTM":"2020-01-23 17:05:41","ADY":188,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.51472,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":188,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.19288,"AVALU":"YEARS","ADTM":"2020-10-20 04:23:56","ADY":71,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.17421,"AVALU":"YEARS","ADTM":"2020-10-13 04:23:56","ADY":64,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.45649,"AVALU":"YEARS","ADTM":"2021-01-24 04:23:56","ADY":167,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":53.28571,"AVALU":"WEEKS","ADTM":"2021-08-17 21:53:10","ADY":373,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-311","SUBJID":"id-311","SITEID":"CHN-4","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.30046,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-06","TRTSDTM":"2020-08-10 04:23:56","TRTEDTM":"2021-02-13 21:48:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":188,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":78.85714,"AVALU":"WEEKS","ADTM":"2022-02-12 21:50:06","ADY":552,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-18 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-19 12:46:18","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.33361,"AVALU":"YEARS","ADTM":"2020-08-17 12:46:18","ADY":122,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-19 12:46:18","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":4.85714,"AVALU":"WEEKS","ADTM":"2020-05-20 03:53:37","ADY":34,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-335","SUBJID":"id-335","SITEID":"CHN-4","AGE":33,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":2.57019,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-13","TRTSDTM":"2020-04-17 12:46:18","TRTEDTM":"2022-04-18 00:24:42","EOSSTT":"COMPLETED","EOSDT":"2022-04-18","EOSDY":731,"LSTALVDT":"2022-05-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":91.14286,"AVALU":"WEEKS","ADTM":"2022-01-14 22:05:25","ADY":638,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-29 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-30 19:54:46","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.66705,"AVALU":"YEARS","ADTM":"2019-11-28 19:54:46","ADY":244,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20295,"AVALU":"YEARS","ADTM":"2019-06-12 19:54:46","ADY":75,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":34.28571,"AVALU":"WEEKS","ADTM":"2019-11-23 06:14:19","ADY":240,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-370","SUBJID":"id-370","SITEID":"CHN-4","AGE":45,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.09845,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-28","TRTSDTM":"2019-03-29 19:54:46","TRTEDTM":"2021-03-29 07:33:10","EOSSTT":"COMPLETED","EOSDT":"2021-03-29","EOSDY":731,"LSTALVDT":"2021-04-10","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":93.28571,"AVALU":"WEEKS","ADTM":"2021-01-09 22:34:55","ADY":653,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-10 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-11 04:01:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01896,"AVALU":"YEARS","ADTM":"2020-02-18 04:01:05","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-11 04:01:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":72.14286,"AVALU":"WEEKS","ADTM":"2021-06-29 09:37:17","ADY":505,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-67","SUBJID":"id-67","SITEID":"CHN-4","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":3.89305,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-10","TRTSDTM":"2020-02-11 04:01:05","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":18.85714,"AVALU":"WEEKS","ADTM":"2020-06-21 05:01:58","ADY":132,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-17 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-18 14:17:33","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-18 14:17:33","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08574,"AVALU":"YEARS","ADTM":"2019-04-18 14:17:33","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":62.14286,"AVALU":"WEEKS","ADTM":"2020-05-24 21:34:05","ADY":435,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-4-id-73","SUBJID":"id-73","SITEID":"CHN-4","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-4","INVNAM":"Dr. CHN-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.86312,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-16","TRTSDTM":"2019-03-17 14:17:33","TRTEDTM":"2021-03-17 01:55:57","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72.71429,"AVALU":"WEEKS","ADTM":"2020-08-06 23:20:57","ADY":509,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-10 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10247,"AVALU":"YEARS","ADTM":"2019-10-19 06:04:07","ADY":38,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.19806,"AVALU":"YEARS","ADTM":"2019-11-23 06:04:07","ADY":73,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01788,"AVALU":"YEARS","ADTM":"2019-09-18 06:04:07","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":71.71429,"AVALU":"WEEKS","ADTM":"2021-01-24 14:01:36","ADY":502,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-108","SUBJID":"id-108","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.74721,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-07","TRTSDTM":"2019-09-11 06:04:07","TRTEDTM":"2021-09-10 17:42:31","EOSSTT":"COMPLETED","EOSDT":"2021-09-10","EOSDY":731,"LSTALVDT":"2021-10-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":2.71429,"AVALU":"WEEKS","ADTM":"2019-09-29 16:16:55","ADY":19,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.73032,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":632,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.73032,"AVALU":"YEARS","ADTM":"2021-02-17 04:15:39","ADY":632,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.73032,"AVALU":"YEARS","ADTM":"2021-02-17 04:15:39","ADY":632,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.47864,"AVALU":"YEARS","ADTM":"2019-11-18 04:15:39","ADY":175,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":37.85714,"AVALU":"WEEKS","ADTM":"2020-02-15 03:18:10","ADY":265,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-159","SUBJID":"id-159","SITEID":"CHN-5","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.54626,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-27 04:15:39","TRTEDTM":"2021-02-16 01:59:05","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":631,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":27.28571,"AVALU":"WEEKS","ADTM":"2019-12-03 02:38:49","ADY":191,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-17 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":11} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.15576,"AVALU":"YEARS","ADTM":"2019-09-12 21:24:10","ADY":57,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.05051,"AVALU":"YEARS","ADTM":"2019-08-05 21:24:10","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14445,"AVALU":"YEARS","ADTM":"2019-09-08 21:24:10","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":84.71429,"AVALU":"WEEKS","ADTM":"2021-02-28 10:38:44","ADY":593,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-160","SUBJID":"id-160","SITEID":"CHN-5","AGE":21,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":0.16545,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-15","TRTSDTM":"2019-07-17 21:24:10","TRTEDTM":"2021-07-17 09:02:34","EOSSTT":"COMPLETED","EOSDT":"2021-07-17","EOSDY":731,"LSTALVDT":"2021-07-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60.85714,"AVALU":"WEEKS","ADTM":"2020-09-14 13:55:05","ADY":426,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-03 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-04 06:26:29","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.80449,"AVALU":"YEARS","ADTM":"2021-07-24 06:26:29","ADY":294,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0316,"AVALU":"YEARS","ADTM":"2020-10-15 06:26:29","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":56.71429,"AVALU":"WEEKS","ADTM":"2021-11-03 02:15:22","ADY":397,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-175","SUBJID":"id-175","SITEID":"CHN-5","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":4.98017,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-09-29","TRTSDTM":"2020-10-03 06:26:29","TRTEDTM":"2022-10-03 18:04:53","EOSSTT":"COMPLETED","EOSDT":"2022-10-03","EOSDY":731,"LSTALVDT":"2022-10-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.71429,"AVALU":"WEEKS","ADTM":"2020-10-07 14:57:12","ADY":5,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-03 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-04 05:46:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08201,"AVALU":"YEARS","ADTM":"2020-04-02 05:46:58","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.10092,"AVALU":"YEARS","ADTM":"2020-04-09 05:46:58","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":83.57143,"AVALU":"WEEKS","ADTM":"2021-10-08 23:29:43","ADY":585,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-195","SUBJID":"id-195","SITEID":"CHN-5","AGE":29,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":1.79756,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-03 05:46:58","TRTEDTM":"2022-03-03 17:25:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":23.85714,"AVALU":"WEEKS","ADTM":"2020-08-16 00:24:26","ADY":167,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-29 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10063,"AVALU":"YEARS","ADTM":"2020-12-04 20:17:15","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09017,"AVALU":"YEARS","ADTM":"2020-11-30 20:17:15","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12542,"AVALU":"YEARS","ADTM":"2020-12-13 20:17:15","ADY":46,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":12,"AVALU":"WEEKS","ADTM":"2021-01-19 17:28:18","ADY":84,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-221","SUBJID":"id-221","SITEID":"CHN-5","AGE":40,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.47576,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-24","TRTSDTM":"2020-10-28 20:17:15","TRTEDTM":"2022-10-29 07:55:39","EOSSTT":"COMPLETED","EOSDT":"2022-10-29","EOSDY":731,"LSTALVDT":"2022-11-13","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":80.57143,"AVALU":"WEEKS","ADTM":"2022-05-14 08:47:57","ADY":564,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-12-08 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.0239,"AVALU":"YEARS","ADTM":"2021-12-16 15:53:46","ADY":374,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11405,"AVALU":"YEARS","ADTM":"2021-01-18 15:53:46","ADY":42,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.64464,"AVALU":"YEARS","ADTM":"2021-07-31 15:53:46","ADY":236,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":51.85714,"AVALU":"WEEKS","ADTM":"2021-12-04 03:59:53","ADY":363,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-231","SUBJID":"id-231","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.59692,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-03","TRTSDTM":"2020-12-07 15:53:46","TRTEDTM":"2022-12-08 03:32:10","EOSSTT":"COMPLETED","EOSDT":"2022-12-08","EOSDY":731,"LSTALVDT":"2022-12-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":55.42857,"AVALU":"WEEKS","ADTM":"2021-12-29 16:14:14","ADY":388,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.13142,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":48,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.13142,"AVALU":"YEARS","ADTM":"2021-02-20 11:27:04","ADY":48,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.13142,"AVALU":"YEARS","ADTM":"2021-02-20 11:27:04","ADY":48,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.09446,"AVALU":"YEARS","ADTM":"2021-02-07 11:27:04","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":102.57143,"AVALU":"WEEKS","ADTM":"2022-12-21 01:07:07","ADY":718,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-273","SUBJID":"id-273","SITEID":"CHN-5","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":10.53634,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-03","TRTSDTM":"2021-01-03 11:27:04","TRTEDTM":"2021-02-19 22:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":48,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":81.85714,"AVALU":"WEEKS","ADTM":"2022-07-29 05:50:25","ADY":573,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.52772,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":558,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1277,"AVALU":"YEARS","ADTM":"2019-09-25 23:22:50","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08905,"AVALU":"YEARS","ADTM":"2019-09-11 23:22:50","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.7475,"AVALU":"YEARS","ADTM":"2020-05-09 23:22:50","ADY":274,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":71.28571,"AVALU":"WEEKS","ADTM":"2020-12-19 10:22:50","ADY":499,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-338","SUBJID":"id-338","SITEID":"CHN-5","AGE":37,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.37538,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-08","TRTSDTM":"2019-08-09 23:22:50","TRTEDTM":"2021-02-16 20:31:07","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":557,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":40,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":102.28571,"AVALU":"WEEKS","ADTM":"2021-07-24 01:33:20","ADY":716,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-23 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-24 08:24:07","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.14993,"AVALU":"YEARS","ADTM":"2020-11-17 08:24:07","ADY":55,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-24 08:24:07","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68.14286,"AVALU":"WEEKS","ADTM":"2022-01-12 12:53:22","ADY":477,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-348","SUBJID":"id-348","SITEID":"CHN-5","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":4.3549,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-21","TRTSDTM":"2020-09-23 08:24:07","TRTEDTM":"2022-09-23 20:02:31","EOSSTT":"COMPLETED","EOSDT":"2022-09-23","EOSDY":731,"LSTALVDT":"2022-10-13","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.42857,"AVALU":"WEEKS","ADTM":"2020-11-20 02:59:34","ADY":59,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.36619,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":499,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.14262,"AVALU":"YEARS","ADTM":"2019-11-30 09:56:37","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.36619,"AVALU":"YEARS","ADTM":"2021-02-18 09:56:37","ADY":499,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11004,"AVALU":"YEARS","ADTM":"2019-11-18 09:56:37","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":27.85714,"AVALU":"WEEKS","ADTM":"2020-04-19 04:07:27","ADY":195,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-5-id-83","SUBJID":"id-83","SITEID":"CHN-5","AGE":44,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-5","INVNAM":"Dr. CHN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.60956,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-10-08","TRTSDTM":"2019-10-08 09:56:37","TRTEDTM":"2021-02-17 18:54:18","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":499,"DCSREAS":"DEATH","DTHDT":"2021-03-28","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":17.85714,"AVALU":"WEEKS","ADTM":"2020-02-09 16:02:06","ADY":125,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.26231,"AVALU":"YEARS","ADTM":"2021-02-21 00:40:32","ADY":96,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10549,"AVALU":"YEARS","ADTM":"2020-12-26 00:40:32","ADY":39,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.42784,"AVALU":"YEARS","ADTM":"2021-04-23 00:40:32","ADY":157,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":83.42857,"AVALU":"WEEKS","ADTM":"2022-06-23 22:42:40","ADY":584,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-248","SUBJID":"id-248","SITEID":"CHN-6","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.11272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 00:40:32","TRTEDTM":"2022-11-17 12:18:56","EOSSTT":"COMPLETED","EOSDT":"2022-11-17","EOSDY":731,"LSTALVDT":"2022-12-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":23.85714,"AVALU":"WEEKS","ADTM":"2021-05-02 01:37:30","ADY":167,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-08-25 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.3074,"AVALU":"YEARS","ADTM":"2020-12-15 12:38:14","ADY":113,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0676,"AVALU":"YEARS","ADTM":"2020-09-18 12:38:14","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00425,"AVALU":"YEARS","ADTM":"2020-08-26 12:38:14","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":66.14286,"AVALU":"WEEKS","ADTM":"2021-11-29 05:57:10","ADY":463,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-30","SUBJID":"id-30","SITEID":"CHN-6","AGE":29,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":12.22076,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-24 12:38:14","TRTEDTM":"2022-08-25 00:16:38","EOSSTT":"COMPLETED","EOSDT":"2022-08-25","EOSDY":731,"LSTALVDT":"2022-09-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":92.85714,"AVALU":"WEEKS","ADTM":"2022-06-04 05:22:10","ADY":650,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17818,"AVALU":"YEARS","ADTM":"2020-01-26 17:38:47","ADY":66,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.39097,"AVALU":"YEARS","ADTM":"2020-04-12 17:38:47","ADY":143,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-21 17:38:47","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":36.57143,"AVALU":"WEEKS","ADTM":"2020-08-02 08:56:33","ADY":256,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-385","SUBJID":"id-385","SITEID":"CHN-6","AGE":40,"SEX":"F","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.68372,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-21 17:38:47","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":44.57143,"AVALU":"WEEKS","ADTM":"2020-09-27 14:05:03","ADY":312,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-24 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.03007,"AVALU":"YEARS","ADTM":"2021-02-03 18:34:19","ADY":11,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.10941,"AVALU":"YEARS","ADTM":"2022-03-05 18:34:19","ADY":406,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01285,"AVALU":"YEARS","ADTM":"2021-01-28 18:34:19","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":64.28571,"AVALU":"WEEKS","ADTM":"2022-04-17 20:36:57","ADY":450,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-6-id-89","SUBJID":"id-89","SITEID":"CHN-6","AGE":39,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-6","INVNAM":"Dr. CHN-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":10.35335,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-23","TRTSDTM":"2021-01-23 18:34:19","TRTEDTM":"2023-01-24 06:12:43","EOSSTT":"COMPLETED","EOSDT":"2023-01-24","EOSDY":731,"LSTALVDT":"2023-02-21","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2021-01-23 18:34:19","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-02 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-03 14:21:14","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.22429,"AVALU":"YEARS","ADTM":"2019-07-23 14:21:14","ADY":82,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-03 14:21:14","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":9.71429,"AVALU":"WEEKS","ADTM":"2019-07-08 03:26:30","ADY":68,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-126","SUBJID":"id-126","SITEID":"CHN-7","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.77455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-02","TRTSDTM":"2019-05-02 14:21:14","TRTEDTM":"2021-05-02 01:59:38","EOSSTT":"COMPLETED","EOSDT":"2021-05-02","EOSDY":731,"LSTALVDT":"2021-05-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":4.71429,"AVALU":"WEEKS","ADTM":"2019-06-03 12:29:05","ADY":33,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.56016,"AVALU":"YEARS","ADTM":"2020-05-29 20:07:36","ADY":205,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.76218,"AVALU":"YEARS","ADTM":"2020-08-11 20:07:36","ADY":279,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.62555,"AVALU":"YEARS","ADTM":"2020-06-22 20:07:36","ADY":229,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":38.42857,"AVALU":"WEEKS","ADTM":"2020-07-31 07:21:51","ADY":269,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-202","SUBJID":"id-202","SITEID":"CHN-7","AGE":44,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.5983,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-05","TRTSDTM":"2019-11-06 20:07:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":79.14286,"AVALU":"WEEKS","ADTM":"2021-05-12 17:01:27","ADY":554,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-01 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.66969,"AVALU":"YEARS","ADTM":"2019-11-02 00:09:16","ADY":245,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.55243,"AVALU":"YEARS","ADTM":"2019-09-20 00:09:16","ADY":202,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.3502,"AVALU":"YEARS","ADTM":"2019-07-08 00:09:16","ADY":128,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":20.14286,"AVALU":"WEEKS","ADTM":"2019-07-20 05:08:19","ADY":141,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-267","SUBJID":"id-267","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.20676,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-01","TRTSDTM":"2019-03-02 00:09:16","TRTEDTM":"2021-03-01 11:47:40","EOSSTT":"COMPLETED","EOSDT":"2021-03-01","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":87.71429,"AVALU":"WEEKS","ADTM":"2020-11-04 18:14:43","ADY":614,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-10 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00522,"AVALU":"YEARS","ADTM":"2019-03-13 09:11:19","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.22253,"AVALU":"YEARS","ADTM":"2019-06-01 09:11:19","ADY":82,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12025,"AVALU":"YEARS","ADTM":"2019-04-24 09:11:19","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.14286,"AVALU":"WEEKS","ADTM":"2019-04-15 14:03:44","ADY":36,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-28","SUBJID":"id-28","SITEID":"CHN-7","AGE":40,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":11.14445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-10","TRTSDTM":"2019-03-11 09:11:19","TRTEDTM":"2021-03-10 20:49:43","EOSSTT":"COMPLETED","EOSDT":"2021-03-10","EOSDY":731,"LSTALVDT":"2021-03-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":45,"AVALU":"WEEKS","ADTM":"2020-01-19 00:57:28","ADY":315,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06362,"AVALU":"YEARS","ADTM":"2021-02-08 02:52:16","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.54738,"AVALU":"YEARS","ADTM":"2021-08-03 02:52:16","ADY":200,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03637,"AVALU":"YEARS","ADTM":"2021-01-29 02:52:16","ADY":14,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":16.14286,"AVALU":"WEEKS","ADTM":"2021-05-07 05:06:20","ADY":113,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-290","SUBJID":"id-290","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.23873,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-11","TRTSDTM":"2021-01-15 02:52:16","TRTEDTM":"2023-01-15 14:30:40","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-01-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2021-01-15 02:52:16","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.2245,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":82,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.103,"AVALU":"YEARS","ADTM":"2021-01-07 05:30:11","ADY":38,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.00599,"AVALU":"YEARS","ADTM":"2020-12-03 05:30:11","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18589,"AVALU":"YEARS","ADTM":"2021-02-06 05:30:11","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":8.28571,"AVALU":"WEEKS","ADTM":"2021-01-26 11:51:13","ADY":58,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-7-id-40","SUBJID":"id-40","SITEID":"CHN-7","AGE":33,"SEX":"M","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-7","INVNAM":"Dr. CHN-7 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":13.16366,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-27","TRTSDTM":"2020-11-30 05:30:11","TRTEDTM":"2021-02-19 07:24:53","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":82,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":35,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.28571,"AVALU":"WEEKS","ADTM":"2021-01-26 01:51:18","ADY":58,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.08761,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":32,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08761,"AVALU":"YEARS","ADTM":"2021-02-19 16:03:00","ADY":32,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08761,"AVALU":"YEARS","ADTM":"2021-02-19 16:03:00","ADY":32,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0647,"AVALU":"YEARS","ADTM":"2021-02-11 16:03:00","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.85714,"AVALU":"WEEKS","ADTM":"2021-02-13 22:17:55","ADY":27,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-205","SUBJID":"id-205","SITEID":"CHN-8","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.15912,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-14","TRTSDTM":"2021-01-18 16:03:00","TRTEDTM":"2021-02-18 00:36:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":31,"DCSREAS":"DEATH","DTHDT":"2021-04-03","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":44,"LDDTHGR1":">30","LSTALVDT":"2021-04-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":57.42857,"AVALU":"WEEKS","ADTM":"2022-02-23 02:30:03","ADY":402,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-08 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.89638,"AVALU":"YEARS","ADTM":"2020-10-02 02:41:29","ADY":328,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.44298,"AVALU":"YEARS","ADTM":"2020-04-19 02:41:29","ADY":162,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16705,"AVALU":"YEARS","ADTM":"2020-01-10 02:41:29","ADY":62,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-11-09 02:41:29","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-8-id-299","SUBJID":"id-299","SITEID":"CHN-8","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-8","INVNAM":"Dr. CHN-8 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":3.15502,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-11-09","TRTSDTM":"2019-11-09 02:41:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":47.28571,"AVALU":"WEEKS","ADTM":"2020-10-04 17:32:33","ADY":331,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.30557,"AVALU":"YEARS","ADTM":"2021-05-19 01:57:07","ADY":112,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.30024,"AVALU":"YEARS","ADTM":"2021-05-17 01:57:07","ADY":110,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.10827,"AVALU":"YEARS","ADTM":"2021-03-08 01:57:07","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":34.42857,"AVALU":"WEEKS","ADTM":"2021-09-24 12:08:04","ADY":241,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-11","SUBJID":"id-11","SITEID":"CHN-9","AGE":28,"SEX":"F","RACE":"NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.26792,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-26","TRTSDTM":"2021-01-27 01:57:07","TRTEDTM":"2023-01-27 13:35:31","EOSSTT":"COMPLETED","EOSDT":"2023-01-27","EOSDY":731,"LSTALVDT":"2023-02-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":35.28571,"AVALU":"WEEKS","ADTM":"2021-09-30 14:56:14","ADY":247,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.79008,"AVALU":"YEARS","ADTM":"2020-11-21 15:53:25","ADY":289,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08989,"AVALU":"YEARS","ADTM":"2020-03-10 15:53:25","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1072,"AVALU":"YEARS","ADTM":"2020-03-17 15:53:25","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":89.57143,"AVALU":"WEEKS","ADTM":"2021-10-24 04:23:12","ADY":627,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-147","SUBJID":"id-147","SITEID":"CHN-9","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"CHN","DTHFL":"N","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.54647,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-02-03","TRTSDTM":"2020-02-06 15:53:25","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":92.85714,"AVALU":"WEEKS","ADTM":"2021-11-16 03:44:17","ADY":650,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.2601,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":95,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.20035,"AVALU":"YEARS","ADTM":"2021-01-30 11:49:31","ADY":74,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20587,"AVALU":"YEARS","ADTM":"2021-02-01 11:49:31","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.15566,"AVALU":"YEARS","ADTM":"2021-01-13 11:49:31","ADY":57,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":86.85714,"AVALU":"WEEKS","ADTM":"2022-07-17 15:01:12","ADY":608,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-CHN-9-id-374","SUBJID":"id-374","SITEID":"CHN-9","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"CHN","DTHFL":"Y","INVID":"INV ID CHN-9","INVNAM":"Dr. CHN-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.75803,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-14","TRTSDTM":"2020-11-17 11:49:31","TRTEDTM":"2021-02-19 17:42:13","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":95,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":6,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":15.71429,"AVALU":"WEEKS","ADTM":"2021-03-06 21:24:28","ADY":110,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-10-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.02284,"AVALU":"YEARS","ADTM":"2020-10-11 12:03:00","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.34168,"AVALU":"YEARS","ADTM":"2021-02-04 12:03:00","ADY":125,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.13226,"AVALU":"YEARS","ADTM":"2020-11-20 12:03:00","ADY":49,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-10-02 12:03:00","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-319","SUBJID":"id-319","SITEID":"GBR-1","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":1.83077,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-02","TRTSDTM":"2020-10-02 12:03:00","TRTEDTM":"2022-10-02 23:41:24","EOSSTT":"COMPLETED","EOSDT":"2022-10-02","EOSDY":731,"LSTALVDT":"2022-10-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":65.57143,"AVALU":"WEEKS","ADTM":"2022-01-03 23:30:20","ADY":459,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.87337,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":319,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.12355,"AVALU":"YEARS","ADTM":"2020-05-18 12:42:14","ADY":46,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.87337,"AVALU":"YEARS","ADTM":"2021-02-15 12:42:14","ADY":319,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20704,"AVALU":"YEARS","ADTM":"2020-06-17 12:42:14","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-04-02 12:42:14","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-355","SUBJID":"id-355","SITEID":"GBR-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":10.62796,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-04-02","TRTSDTM":"2020-04-02 12:42:14","TRTEDTM":"2021-02-14 06:32:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":318,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":78.85714,"AVALU":"WEEKS","ADTM":"2021-10-05 19:13:12","ADY":552,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.0705,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":391,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.0705,"AVALU":"YEARS","ADTM":"2021-02-13 06:47:57","ADY":391,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07094,"AVALU":"YEARS","ADTM":"2020-02-14 06:47:57","ADY":26,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.19052,"AVALU":"YEARS","ADTM":"2020-03-29 06:47:57","ADY":70,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":95.42857,"AVALU":"WEEKS","ADTM":"2021-11-16 15:58:57","ADY":668,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-1-id-384","SUBJID":"id-384","SITEID":"GBR-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-1","INVNAM":"Dr. GBR-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":2.644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-16","TRTSDTM":"2020-01-19 06:47:57","TRTEDTM":"2021-02-12 23:39:33","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":391,"DCSREAS":"DEATH","DTHDT":"2021-02-12","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":0,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":11.85714,"AVALU":"WEEKS","ADTM":"2020-04-10 03:01:43","ADY":83,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.75017,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":274,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11514,"AVALU":"YEARS","ADTM":"2020-06-29 10:14:56","ADY":43,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.00855,"AVALU":"YEARS","ADTM":"2020-05-21 10:14:56","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.34188,"AVALU":"YEARS","ADTM":"2020-09-19 10:14:56","ADY":125,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.85714,"AVALU":"WEEKS","ADTM":"2020-05-22 08:02:19","ADY":6,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-340","SUBJID":"id-340","SITEID":"GBR-11","AGE":26,"SEX":"F","RACE":"WHITE","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.11634,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-05-13","TRTSDTM":"2020-05-17 10:14:56","TRTEDTM":"2021-02-14 00:17:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":273,"DCSREAS":"DEATH","DTHDT":"2021-03-24","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":38,"LDDTHGR1":">30","LSTALVDT":"2021-03-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":44.42857,"AVALU":"WEEKS","ADTM":"2021-03-23 18:45:03","ADY":311,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-30 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.15131,"AVALU":"YEARS","ADTM":"2020-02-25 19:18:54","ADY":56,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.11127,"AVALU":"YEARS","ADTM":"2020-02-10 19:18:54","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24626,"AVALU":"YEARS","ADTM":"2020-03-30 19:18:54","ADY":90,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":79,"AVALU":"WEEKS","ADTM":"2021-07-05 02:51:55","ADY":553,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-11-id-390","SUBJID":"id-390","SITEID":"GBR-11","AGE":69,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-11","INVNAM":"Dr. GBR-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":2.05012,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-27","TRTSDTM":"2019-12-31 19:18:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":61.57143,"AVALU":"WEEKS","ADTM":"2021-03-05 06:09:54","ADY":431,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-25 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.73922,"AVALU":"YEARS","ADTM":"2021-07-22 19:28:14","ADY":271,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.27867,"AVALU":"YEARS","ADTM":"2021-02-03 19:28:14","ADY":102,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00399,"AVALU":"YEARS","ADTM":"2020-10-26 19:28:14","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-10-24 19:28:14","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-13-id-80","SUBJID":"id-80","SITEID":"GBR-13","AGE":28,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-13","INVNAM":"Dr. GBR-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"C","STRATA2":"S1","BMRKR1":7.74987,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-21","TRTSDTM":"2020-10-24 19:28:14","TRTEDTM":"2022-10-25 07:06:38","EOSSTT":"COMPLETED","EOSDT":"2022-10-25","EOSDY":731,"LSTALVDT":"2022-11-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":1.71429,"AVALU":"WEEKS","ADTM":"2020-11-04 05:35:15","ADY":12,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.75017,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":274,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.56644,"AVALU":"YEARS","ADTM":"2020-12-14 08:44:17","ADY":207,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.75017,"AVALU":"YEARS","ADTM":"2021-02-19 08:44:17","ADY":274,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.48252,"AVALU":"YEARS","ADTM":"2020-11-14 08:44:17","ADY":177,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":95,"AVALU":"WEEKS","ADTM":"2022-03-16 07:06:57","ADY":665,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-15-id-293","SUBJID":"id-293","SITEID":"GBR-15","AGE":27,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-15","INVNAM":"Dr. GBR-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Europe","STRATA1":"B","STRATA2":"S1","BMRKR1":1.56299,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-18","TRTSDTM":"2020-05-21 08:44:17","TRTEDTM":"2021-02-18 09:36:09","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":274,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72.28571,"AVALU":"WEEKS","ADTM":"2021-10-08 12:16:31","ADY":506,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.15332,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":56,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08475,"AVALU":"YEARS","ADTM":"2021-01-23 02:52:30","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08487,"AVALU":"YEARS","ADTM":"2021-01-23 02:52:30","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12819,"AVALU":"YEARS","ADTM":"2021-02-08 02:52:30","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":69,"AVALU":"WEEKS","ADTM":"2022-04-19 03:47:28","ADY":483,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-17-id-211","SUBJID":"id-211","SITEID":"GBR-17","AGE":62,"SEX":"M","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"Y","INVID":"INV ID GBR-17","INVNAM":"Dr. GBR-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"A","STRATA2":"S1","BMRKR1":3.72545,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-20","TRTSDTM":"2020-12-23 02:52:30","TRTEDTM":"2021-02-16 15:57:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":56,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":27,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":21.71429,"AVALU":"WEEKS","ADTM":"2021-05-23 15:00:48","ADY":152,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-28 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01879,"AVALU":"YEARS","ADTM":"2019-08-05 00:24:38","ADY":7,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.91184,"AVALU":"YEARS","ADTM":"2020-06-27 00:24:38","ADY":334,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05939,"AVALU":"YEARS","ADTM":"2019-08-20 00:24:38","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":5.57143,"AVALU":"WEEKS","ADTM":"2019-09-05 04:45:42","ADY":39,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-GBR-6-id-111","SUBJID":"id-111","SITEID":"GBR-6","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"GBR","DTHFL":"N","INVID":"INV ID GBR-6","INVNAM":"Dr. GBR-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Europe","STRATA1":"B","STRATA2":"S2","BMRKR1":4.67011,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 00:24:38","TRTEDTM":"2021-07-28 12:03:02","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-13","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":73.57143,"AVALU":"WEEKS","ADTM":"2020-12-24 19:32:58","ADY":515,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-18 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.52993,"AVALU":"YEARS","ADTM":"2021-05-30 23:08:35","ADY":194,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.2723,"AVALU":"YEARS","ADTM":"2022-02-25 23:08:35","ADY":465,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06693,"AVALU":"YEARS","ADTM":"2020-12-12 23:08:35","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":91.14286,"AVALU":"WEEKS","ADTM":"2022-08-16 22:22:43","ADY":638,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-21","SUBJID":"id-21","SITEID":"JPN-1","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":13.29869,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-11-15","TRTSDTM":"2020-11-17 23:08:35","TRTEDTM":"2022-11-18 10:46:59","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":50.85714,"AVALU":"WEEKS","ADTM":"2021-11-07 16:01:34","ADY":356,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":497,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1686,"AVALU":"YEARS","ADTM":"2019-12-10 16:18:36","ADY":62,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-17 16:18:36","ADY":497,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.44108,"AVALU":"YEARS","ADTM":"2020-03-19 16:18:36","ADY":162,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":19.14286,"AVALU":"WEEKS","ADTM":"2020-02-19 00:31:57","ADY":134,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-218","SUBJID":"id-218","SITEID":"JPN-1","AGE":35,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.8133,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-05","TRTSDTM":"2019-10-09 16:18:36","TRTEDTM":"2021-02-16 20:03:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":497,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":96.28571,"AVALU":"WEEKS","ADTM":"2021-08-12 22:48:55","ADY":674,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-06 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-07 03:27:28","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01638,"AVALU":"YEARS","ADTM":"2019-12-13 03:27:28","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00288,"AVALU":"YEARS","ADTM":"2019-12-09 03:27:28","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.71429,"AVALU":"WEEKS","ADTM":"2020-04-08 12:27:11","ADY":124,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-225","SUBJID":"id-225","SITEID":"JPN-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":1.86373,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-07 03:27:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60,"AVALU":"WEEKS","ADTM":"2021-01-29 06:57:43","ADY":420,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-07 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.3571,"AVALU":"YEARS","ADTM":"2020-09-15 07:35:37","ADY":131,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.41554,"AVALU":"YEARS","ADTM":"2020-10-06 07:35:37","ADY":152,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.20981,"AVALU":"YEARS","ADTM":"2020-07-23 07:35:37","ADY":77,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":79.71429,"AVALU":"WEEKS","ADTM":"2021-11-15 10:17:07","ADY":558,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-300","SUBJID":"id-300","SITEID":"JPN-1","AGE":35,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":6.97287,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-05-04","TRTSDTM":"2020-05-07 07:35:37","TRTEDTM":"2022-05-07 19:14:01","EOSSTT":"COMPLETED","EOSDT":"2022-05-07","EOSDY":731,"LSTALVDT":"2022-06-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":19.85714,"AVALU":"WEEKS","ADTM":"2020-09-22 15:42:47","ADY":139,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-10 08:42:09","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-10 08:42:09","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07797,"AVALU":"YEARS","ADTM":"2019-11-08 08:42:09","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":100,"AVALU":"WEEKS","ADTM":"2021-09-08 01:15:42","ADY":700,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-1-id-7","SUBJID":"id-7","SITEID":"JPN-1","AGE":54,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-1","INVNAM":"Dr. JPN-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.08724,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-10 08:42:09","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":36.14286,"AVALU":"WEEKS","ADTM":"2020-06-18 14:36:49","ADY":253,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":497,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-20 13:22:14","ADY":497,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-20 13:22:14","ADY":497,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.36071,"AVALU":"YEARS","ADTM":"2021-02-20 13:22:14","ADY":497,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":36.28571,"AVALU":"WEEKS","ADTM":"2020-06-21 18:45:35","ADY":254,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-135","SUBJID":"id-135","SITEID":"JPN-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.12703,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-10-09","TRTSDTM":"2019-10-12 13:22:14","TRTEDTM":"2021-02-19 15:10:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":497,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":39.57143,"AVALU":"WEEKS","ADTM":"2020-07-14 13:08:11","ADY":277,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.47639,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":174,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.47639,"AVALU":"YEARS","ADTM":"2021-02-15 06:54:26","ADY":174,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08366,"AVALU":"YEARS","ADTM":"2020-09-25 06:54:26","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.47639,"AVALU":"YEARS","ADTM":"2021-02-15 06:54:26","ADY":174,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":81.57143,"AVALU":"WEEKS","ADTM":"2022-03-18 00:05:06","ADY":571,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-373","SUBJID":"id-373","SITEID":"JPN-11","AGE":45,"SEX":"M","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.03424,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-22","TRTSDTM":"2020-08-25 06:54:26","TRTEDTM":"2021-02-14 06:59:42","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":174,"DCSREAS":"DEATH","DTHDT":"2021-04-04","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":49,"LDDTHGR1":">30","LSTALVDT":"2021-04-04","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":73.14286,"AVALU":"WEEKS","ADTM":"2022-01-18 17:50:49","ADY":512,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-22 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.54135,"AVALU":"YEARS","ADTM":"2021-07-08 00:19:35","ADY":198,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02079,"AVALU":"YEARS","ADTM":"2020-12-30 00:19:35","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01938,"AVALU":"YEARS","ADTM":"2020-12-30 00:19:35","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":102.57143,"AVALU":"WEEKS","ADTM":"2022-12-09 15:30:56","ADY":718,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-11-id-61","SUBJID":"id-61","SITEID":"JPN-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-11","INVNAM":"Dr. JPN-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":14.00869,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-12-18","TRTSDTM":"2020-12-22 00:19:35","TRTEDTM":"2022-12-22 11:57:59","EOSSTT":"COMPLETED","EOSDT":"2022-12-22","EOSDY":731,"LSTALVDT":"2023-01-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":57.57143,"AVALU":"WEEKS","ADTM":"2022-01-28 20:48:25","ADY":403,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-03 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-05-04 04:49:57","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.36104,"AVALU":"YEARS","ADTM":"2020-09-12 04:49:57","ADY":132,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.09009,"AVALU":"YEARS","ADTM":"2020-06-05 04:49:57","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":22,"AVALU":"WEEKS","ADTM":"2020-10-03 02:36:17","ADY":154,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-12-id-219","SUBJID":"id-219","SITEID":"JPN-12","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-12","INVNAM":"Dr. JPN-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.39188,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-30","TRTSDTM":"2020-05-03 04:49:57","TRTEDTM":"2022-05-03 16:28:21","EOSSTT":"COMPLETED","EOSDT":"2022-05-03","EOSDY":731,"LSTALVDT":"2022-05-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":6.85714,"AVALU":"WEEKS","ADTM":"2020-06-19 23:12:50","ADY":48,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-31 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.15426,"AVALU":"YEARS","ADTM":"2019-12-28 00:06:53","ADY":57,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.37084,"AVALU":"YEARS","ADTM":"2020-03-16 00:06:53","ADY":136,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-01 00:06:53","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":81,"AVALU":"WEEKS","ADTM":"2021-05-20 02:17:43","ADY":567,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-14-id-194","SUBJID":"id-194","SITEID":"JPN-14","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-14","INVNAM":"Dr. JPN-14 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.44686,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-31","TRTSDTM":"2019-11-01 00:06:53","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-11-01 00:06:53","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-02-17 09:38:40","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08783,"AVALU":"YEARS","ADTM":"2020-03-21 09:38:40","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12648,"AVALU":"YEARS","ADTM":"2020-04-04 09:38:40","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":9.71429,"AVALU":"WEEKS","ADTM":"2020-04-24 04:49:43","ADY":68,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-250","SUBJID":"id-250","SITEID":"JPN-17","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":5.45958,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-17","TRTSDTM":"2020-02-17 09:38:40","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":29,"AVALU":"WEEKS","ADTM":"2020-09-06 17:16:43","ADY":203,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.68446,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":250,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.25428,"AVALU":"YEARS","ADTM":"2020-09-09 23:30:44","ADY":93,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.68446,"AVALU":"YEARS","ADTM":"2021-02-13 23:30:44","ADY":250,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.68446,"AVALU":"YEARS","ADTM":"2021-02-13 23:30:44","ADY":250,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":52.71429,"AVALU":"WEEKS","ADTM":"2021-06-11 18:22:35","ADY":369,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-17-id-393","SUBJID":"id-393","SITEID":"JPN-17","AGE":26,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-17","INVNAM":"Dr. JPN-17 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65965,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-06-07","TRTSDTM":"2020-06-08 23:30:44","TRTEDTM":"2021-02-12 15:33:50","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":249,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-06-08 23:30:44","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-10 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17842,"AVALU":"YEARS","ADTM":"2020-11-14 19:38:06","ADY":66,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-11 19:38:06","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01563,"AVALU":"YEARS","ADTM":"2020-09-15 19:38:06","ADY":6,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":11.71429,"AVALU":"WEEKS","ADTM":"2020-11-29 18:26:36","ADY":82,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-18-id-189","SUBJID":"id-189","SITEID":"JPN-18","AGE":48,"SEX":"M","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-18","INVNAM":"Dr. JPN-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.84644,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-09 19:38:06","TRTEDTM":"2022-09-10 07:16:30","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-10-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":59.28571,"AVALU":"WEEKS","ADTM":"2021-10-28 22:28:22","ADY":415,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.89528,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":327,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.89528,"AVALU":"YEARS","ADTM":"2021-02-18 08:20:34","ADY":327,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.89528,"AVALU":"YEARS","ADTM":"2021-02-18 08:20:34","ADY":327,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.21878,"AVALU":"YEARS","ADTM":"2020-06-16 08:20:34","ADY":80,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":78.42857,"AVALU":"WEEKS","ADTM":"2021-09-27 19:20:45","ADY":549,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-2-id-214","SUBJID":"id-214","SITEID":"JPN-2","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-2","INVNAM":"Dr. JPN-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.13205,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-03-26","TRTSDTM":"2020-03-28 08:20:34","TRTEDTM":"2021-02-17 15:45:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":327,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-13","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":27.14286,"AVALU":"WEEKS","ADTM":"2020-10-03 03:44:15","ADY":190,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.38498,"AVALU":"YEARS","ADTM":"2020-03-06 05:23:15","ADY":141,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23844,"AVALU":"YEARS","ADTM":"2020-01-13 05:23:15","ADY":88,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18558,"AVALU":"YEARS","ADTM":"2019-12-24 05:23:15","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68.57143,"AVALU":"WEEKS","ADTM":"2021-02-07 06:25:36","ADY":480,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-3-id-109","SUBJID":"id-109","SITEID":"JPN-3","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-3","INVNAM":"Dr. JPN-3 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":9.20387,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-10-16","TRTSDTM":"2019-10-17 05:23:15","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":45.71429,"AVALU":"WEEKS","ADTM":"2020-08-31 15:54:44","ADY":320,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.33676,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":123,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06508,"AVALU":"YEARS","ADTM":"2020-11-09 04:46:43","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.16783,"AVALU":"YEARS","ADTM":"2020-12-17 04:46:43","ADY":62,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1371,"AVALU":"YEARS","ADTM":"2020-12-06 04:46:43","ADY":51,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":10.14286,"AVALU":"WEEKS","ADTM":"2020-12-25 03:15:11","ADY":71,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-252","SUBJID":"id-252","SITEID":"JPN-5","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54319,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-16","TRTSDTM":"2020-10-16 04:46:43","TRTEDTM":"2021-02-15 16:52:04","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":123,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":42.85714,"AVALU":"WEEKS","ADTM":"2021-08-11 15:19:11","ADY":300,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.24645,"AVALU":"YEARS","ADTM":"2020-02-02 13:02:50","ADY":91,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08935,"AVALU":"YEARS","ADTM":"2019-12-06 13:02:50","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.34403,"AVALU":"YEARS","ADTM":"2020-03-08 13:02:50","ADY":126,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":82,"AVALU":"WEEKS","ADTM":"2021-05-29 20:10:51","ADY":574,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-5-id-326","SUBJID":"id-326","SITEID":"JPN-5","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"JPN","DTHFL":"N","INVID":"INV ID JPN-5","INVNAM":"Dr. JPN-5 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":8.09449,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-11-03","TRTSDTM":"2019-11-03 13:02:50","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":72.85714,"AVALU":"WEEKS","ADTM":"2021-03-26 14:32:44","ADY":510,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.10951,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":40,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10951,"AVALU":"YEARS","ADTM":"2021-02-15 23:00:18","ADY":40,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03683,"AVALU":"YEARS","ADTM":"2021-01-20 23:00:18","ADY":14,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05194,"AVALU":"YEARS","ADTM":"2021-01-25 23:00:18","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":23,"AVALU":"WEEKS","ADTM":"2021-06-15 05:36:05","ADY":161,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-JPN-6-id-260","SUBJID":"id-260","SITEID":"JPN-6","AGE":29,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"JPN","DTHFL":"Y","INVID":"INV ID JPN-6","INVNAM":"Dr. JPN-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":2.71335,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2021-01-03","TRTSDTM":"2021-01-06 23:00:18","TRTEDTM":"2021-02-14 16:40:29","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":39,"DCSREAS":"DEATH","DTHDT":"2021-02-28","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":14,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":78.57143,"AVALU":"WEEKS","ADTM":"2022-07-09 06:39:50","ADY":550,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-06 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.27493,"AVALU":"YEARS","ADTM":"2020-06-15 08:18:42","ADY":101,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.55922,"AVALU":"YEARS","ADTM":"2020-09-27 08:18:42","ADY":205,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-07 08:18:42","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":16.85714,"AVALU":"WEEKS","ADTM":"2020-07-01 06:47:47","ADY":118,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-172","SUBJID":"id-172","SITEID":"NGA-1","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.61988,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-02","TRTSDTM":"2020-03-06 08:18:42","TRTEDTM":"2022-03-06 19:57:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-06","EOSDY":731,"LSTALVDT":"2022-03-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":77.85714,"AVALU":"WEEKS","ADTM":"2021-09-01 15:25:53","ADY":545,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-25 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17371,"AVALU":"YEARS","ADTM":"2020-02-28 17:25:12","ADY":64,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-26 17:25:12","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14359,"AVALU":"YEARS","ADTM":"2020-02-17 17:25:12","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.57143,"AVALU":"WEEKS","ADTM":"2020-11-15 01:26:25","ADY":326,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-198","SUBJID":"id-198","SITEID":"NGA-1","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":8.96,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-26 17:25:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":77.14286,"AVALU":"WEEKS","ADTM":"2021-06-17 05:33:02","ADY":540,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-08-31 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-01 00:33:10","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.49878,"AVALU":"YEARS","ADTM":"2020-03-02 00:33:10","ADY":183,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14415,"AVALU":"YEARS","ADTM":"2019-10-24 00:33:10","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68,"AVALU":"WEEKS","ADTM":"2020-12-19 12:00:41","ADY":476,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-200","SUBJID":"id-200","SITEID":"NGA-1","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.92477,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-30","TRTSDTM":"2019-09-01 00:33:10","TRTEDTM":"2021-08-31 12:11:34","EOSSTT":"COMPLETED","EOSDT":"2021-08-31","EOSDY":731,"LSTALVDT":"2021-09-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60.57143,"AVALU":"WEEKS","ADTM":"2020-10-28 05:08:27","ADY":424,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.44832,"AVALU":"YEARS","ADTM":"2021-02-17 00:00:00","ADY":529,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.44832,"AVALU":"YEARS","ADTM":"2021-02-18 13:17:05","ADY":529,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0761,"AVALU":"YEARS","ADTM":"2019-10-06 13:17:05","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.44832,"AVALU":"YEARS","ADTM":"2021-02-18 13:17:05","ADY":529,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.71429,"AVALU":"WEEKS","ADTM":"2019-10-03 19:08:55","ADY":26,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-325","SUBJID":"id-325","SITEID":"NGA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":7.97282,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-07","TRTSDTM":"2019-09-08 13:17:05","TRTEDTM":"2021-02-17 04:46:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-17","EOSDY":528,"DCSREAS":"DEATH","DTHDT":"2021-03-15","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":26,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":20.85714,"AVALU":"WEEKS","ADTM":"2020-01-31 12:20:30","ADY":146,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.11978,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":409,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.39816,"AVALU":"YEARS","ADTM":"2020-05-26 08:14:02","ADY":146,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.75848,"AVALU":"YEARS","ADTM":"2020-10-05 08:14:02","ADY":278,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05516,"AVALU":"YEARS","ADTM":"2020-01-22 08:14:02","ADY":21,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":38.42857,"AVALU":"WEEKS","ADTM":"2020-09-25 08:33:31","ADY":269,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-327","SUBJID":"id-327","SITEID":"NGA-1","AGE":36,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.09908,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-01","TRTSDTM":"2020-01-01 08:14:02","TRTEDTM":"2021-02-12 10:26:15","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":409,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":68.42857,"AVALU":"WEEKS","ADTM":"2021-04-23 18:00:58","ADY":479,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1776,"AVALU":"YEARS","ADTM":"2020-03-26 02:54:36","ADY":65,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10779,"AVALU":"YEARS","ADTM":"2020-03-01 02:54:36","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-21 02:54:36","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":47,"AVALU":"WEEKS","ADTM":"2020-12-14 22:35:30","ADY":329,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-357","SUBJID":"id-357","SITEID":"NGA-1","AGE":41,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.82877,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-17","TRTSDTM":"2020-01-21 02:54:36","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":77.85714,"AVALU":"WEEKS","ADTM":"2021-07-18 17:30:39","ADY":545,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-17 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-18 15:00:47","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-18 15:00:47","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04751,"AVALU":"YEARS","ADTM":"2019-06-04 15:00:47","ADY":18,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-05-17 15:00:47","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-388","SUBJID":"id-388","SITEID":"NGA-1","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-17","TRTSDTM":"2019-05-17 15:00:47","TRTEDTM":"2021-05-17 02:39:11","EOSSTT":"COMPLETED","EOSDT":"2021-05-17","EOSDY":731,"LSTALVDT":"2021-06-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":64.42857,"AVALU":"WEEKS","ADTM":"2020-08-09 06:41:55","ADY":451,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-10 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-11 03:03:45","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03128,"AVALU":"YEARS","ADTM":"2020-09-22 03:03:45","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.2343,"AVALU":"YEARS","ADTM":"2020-12-05 03:03:45","ADY":86,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-09-10 03:03:45","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-43","SUBJID":"id-43","SITEID":"NGA-1","AGE":37,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":5.08774,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-09-08","TRTSDTM":"2020-09-10 03:03:45","TRTEDTM":"2022-09-10 14:42:09","EOSSTT":"COMPLETED","EOSDT":"2022-09-10","EOSDY":731,"LSTALVDT":"2022-09-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":87,"AVALU":"WEEKS","ADTM":"2022-05-11 08:58:11","ADY":609,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-02 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-03 19:53:09","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.07233,"AVALU":"YEARS","ADTM":"2021-04-28 19:53:09","ADY":392,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.49883,"AVALU":"YEARS","ADTM":"2020-10-01 19:53:09","ADY":183,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":14.42857,"AVALU":"WEEKS","ADTM":"2020-07-10 19:11:00","ADY":101,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-46","SUBJID":"id-46","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":3.84648,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-29","TRTSDTM":"2020-04-01 19:53:09","TRTEDTM":"2022-04-02 07:31:33","EOSSTT":"COMPLETED","EOSDT":"2022-04-02","EOSDY":731,"LSTALVDT":"2022-04-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-04-01 19:53:09","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-21 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-22 22:16:30","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-07-22 22:16:30","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.21069,"AVALU":"YEARS","ADTM":"2019-10-06 22:16:30","ADY":77,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":92,"AVALU":"WEEKS","ADTM":"2021-04-24 21:18:04","ADY":644,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-1-id-96","SUBJID":"id-96","SITEID":"NGA-1","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-1","INVNAM":"Dr. NGA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":12.92348,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-17","TRTSDTM":"2019-07-21 22:16:30","TRTEDTM":"2021-07-21 09:54:54","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-07-21 22:16:30","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1119,"AVALU":"YEARS","ADTM":"2019-04-20 09:34:58","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0942,"AVALU":"YEARS","ADTM":"2019-04-14 09:34:58","ADY":35,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.38214,"AVALU":"YEARS","ADTM":"2019-07-28 09:34:58","ADY":140,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":55.14286,"AVALU":"WEEKS","ADTM":"2020-03-29 20:22:28","ADY":386,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-173","SUBJID":"id-173","SITEID":"NGA-11","AGE":24,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.99723,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-03-08","TRTSDTM":"2019-03-10 09:34:58","TRTEDTM":"2021-03-09 21:13:22","EOSSTT":"COMPLETED","EOSDT":"2021-03-09","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":28.71429,"AVALU":"WEEKS","ADTM":"2019-09-26 19:51:39","ADY":201,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.77139,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":647,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.38325,"AVALU":"YEARS","ADTM":"2019-09-29 18:41:44","ADY":140,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.40243,"AVALU":"YEARS","ADTM":"2019-10-06 18:41:44","ADY":147,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.4184,"AVALU":"YEARS","ADTM":"2019-10-12 18:41:44","ADY":153,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":39,"AVALU":"WEEKS","ADTM":"2020-02-08 12:56:19","ADY":273,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-313","SUBJID":"id-313","SITEID":"NGA-11","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":2.91108,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 18:41:44","TRTEDTM":"2021-02-16 06:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":646,"DCSREAS":"DEATH","DTHDT":"2021-03-17","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":29,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-05-12 18:41:44","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06892,"AVALU":"YEARS","ADTM":"2021-02-11 08:40:36","ADY":26,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09039,"AVALU":"YEARS","ADTM":"2021-02-19 08:40:36","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2023-01-17 08:40:36","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":14.57143,"AVALU":"WEEKS","ADTM":"2021-04-27 04:06:06","ADY":102,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-334","SUBJID":"id-334","SITEID":"NGA-11","AGE":20,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":2.90932,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-16","TRTSDTM":"2021-01-16 08:40:36","TRTEDTM":"2023-01-16 20:19:00","EOSSTT":"COMPLETED","EOSDT":"2023-01-16","EOSDY":731,"LSTALVDT":"2023-02-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":55.85714,"AVALU":"WEEKS","ADTM":"2022-02-10 17:35:01","ADY":391,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.48118,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":541,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.39864,"AVALU":"YEARS","ADTM":"2020-01-19 05:04:59","ADY":146,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.59748,"AVALU":"YEARS","ADTM":"2020-04-01 05:04:59","ADY":219,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01023,"AVALU":"YEARS","ADTM":"2019-08-30 05:04:59","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":101.57143,"AVALU":"WEEKS","ADTM":"2021-08-05 15:35:40","ADY":711,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-35","SUBJID":"id-35","SITEID":"NGA-11","AGE":32,"SEX":"M","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":9.02841,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-24","TRTSDTM":"2019-08-26 05:04:59","TRTEDTM":"2021-02-16 16:24:23","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":541,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":34,"AVALU":"WEEKS","ADTM":"2020-04-19 10:53:04","ADY":238,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-06 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.34872,"AVALU":"YEARS","ADTM":"2021-02-10 21:03:35","ADY":128,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.26002,"AVALU":"YEARS","ADTM":"2021-01-08 21:03:35","ADY":95,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.41514,"AVALU":"YEARS","ADTM":"2021-03-06 21:03:35","ADY":152,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":44.57143,"AVALU":"WEEKS","ADTM":"2021-08-12 23:00:30","ADY":312,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-366","SUBJID":"id-366","SITEID":"NGA-11","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":3.31624,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-10-04","TRTSDTM":"2020-10-05 21:03:35","TRTEDTM":"2022-10-06 08:41:59","EOSSTT":"COMPLETED","EOSDT":"2022-10-06","EOSDY":731,"LSTALVDT":"2022-11-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":103.14286,"AVALU":"WEEKS","ADTM":"2022-09-26 11:40:46","ADY":722,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-01 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-02 00:36:36","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.85799,"AVALU":"YEARS","ADTM":"2021-06-11 00:36:36","ADY":314,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08514,"AVALU":"YEARS","ADTM":"2020-09-02 00:36:36","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":21,"AVALU":"WEEKS","ADTM":"2020-12-25 20:56:19","ADY":147,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-11-id-41","SUBJID":"id-41","SITEID":"NGA-11","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-11","INVNAM":"Dr. NGA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S2","BMRKR1":7.20651,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-28","TRTSDTM":"2020-08-01 00:36:36","TRTEDTM":"2022-08-01 12:15:00","EOSSTT":"COMPLETED","EOSDT":"2022-08-01","EOSDY":731,"LSTALVDT":"2022-08-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":23.71429,"AVALU":"WEEKS","ADTM":"2021-01-13 09:22:31","ADY":166,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-04-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.51591,"AVALU":"YEARS","ADTM":"2020-10-15 05:58:21","ADY":189,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.45172,"AVALU":"YEARS","ADTM":"2020-09-21 05:58:21","ADY":165,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.51053,"AVALU":"YEARS","ADTM":"2020-10-13 05:58:21","ADY":187,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-04-09 05:58:21","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-264","SUBJID":"id-264","SITEID":"NGA-12","AGE":24,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.82764,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-06","TRTSDTM":"2020-04-09 05:58:21","TRTEDTM":"2022-04-09 17:36:45","EOSSTT":"COMPLETED","EOSDT":"2022-04-09","EOSDY":731,"LSTALVDT":"2022-05-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":56.71429,"AVALU":"WEEKS","ADTM":"2021-05-10 09:06:47","ADY":397,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.10883,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":405,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.26745,"AVALU":"YEARS","ADTM":"2020-04-14 16:58:08","ADY":98,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06232,"AVALU":"YEARS","ADTM":"2020-01-30 16:58:08","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.22698,"AVALU":"YEARS","ADTM":"2020-03-30 16:58:08","ADY":83,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":18.28571,"AVALU":"WEEKS","ADTM":"2020-05-13 16:20:04","ADY":128,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-12-id-387","SUBJID":"id-387","SITEID":"NGA-12","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-12","INVNAM":"Dr. NGA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.36861,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-01-05","TRTSDTM":"2020-01-07 16:58:08","TRTEDTM":"2021-02-14 01:45:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":404,"DCSREAS":"DEATH","DTHDT":"2021-03-02","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":16,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":39.85714,"AVALU":"WEEKS","ADTM":"2020-10-11 22:22:18","ADY":279,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-06 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-07 15:48:30","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-07 15:48:30","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24443,"AVALU":"YEARS","ADTM":"2020-08-03 15:48:30","ADY":90,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":93.42857,"AVALU":"WEEKS","ADTM":"2022-02-17 08:44:59","ADY":654,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-230","SUBJID":"id-230","SITEID":"NGA-17","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":17.67234,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-05-05","TRTSDTM":"2020-05-05 15:48:30","TRTEDTM":"2022-05-06 03:26:54","EOSSTT":"COMPLETED","EOSDT":"2022-05-06","EOSDY":731,"LSTALVDT":"2022-05-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":69.42857,"AVALU":"WEEKS","ADTM":"2021-09-02 03:34:43","ADY":486,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.42368,"AVALU":"YEARS","ADTM":"2021-02-11 00:00:00","ADY":520,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.36942,"AVALU":"YEARS","ADTM":"2020-01-24 13:25:34","ADY":135,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.42368,"AVALU":"YEARS","ADTM":"2021-02-12 13:25:34","ADY":520,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.38631,"AVALU":"YEARS","ADTM":"2020-01-31 13:25:34","ADY":142,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":95.57143,"AVALU":"WEEKS","ADTM":"2021-07-10 07:32:54","ADY":669,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-17-id-72","SUBJID":"id-72","SITEID":"NGA-17","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-17","INVNAM":"Dr. NGA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":6.40254,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-09","TRTSDTM":"2019-09-11 13:25:34","TRTEDTM":"2021-02-11 23:12:41","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-11","EOSDY":520,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":79.14286,"AVALU":"WEEKS","ADTM":"2021-03-17 04:12:06","ADY":554,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.39083,"AVALU":"YEARS","ADTM":"2021-02-13 00:00:00","ADY":508,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.39083,"AVALU":"YEARS","ADTM":"2021-02-14 10:37:38","ADY":508,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.39083,"AVALU":"YEARS","ADTM":"2021-02-14 10:37:38","ADY":508,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.66823,"AVALU":"YEARS","ADTM":"2020-05-27 10:37:38","ADY":245,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-09-25 10:37:38","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-308","SUBJID":"id-308","SITEID":"NGA-2","AGE":26,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"Y","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":4.824,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-09-22","TRTSDTM":"2019-09-25 10:37:38","TRTEDTM":"2021-02-13 05:01:38","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-13","EOSDY":507,"DCSREAS":"DEATH","DTHDT":"2021-03-22","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":37,"LDDTHGR1":">30","LSTALVDT":"2021-03-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":15.85714,"AVALU":"WEEKS","ADTM":"2020-01-13 20:54:59","ADY":111,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-03 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17132,"AVALU":"YEARS","ADTM":"2020-05-04 21:15:39","ADY":63,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-04 21:15:39","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07128,"AVALU":"YEARS","ADTM":"2020-03-29 21:15:39","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68.71429,"AVALU":"WEEKS","ADTM":"2021-06-25 23:17:50","ADY":481,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-2-id-353","SUBJID":"id-353","SITEID":"NGA-2","AGE":28,"SEX":"M","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-2","INVNAM":"Dr. NGA-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"B","STRATA2":"S1","BMRKR1":3.94481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-02-28","TRTSDTM":"2020-03-02 21:15:39","TRTEDTM":"2022-03-03 08:54:03","EOSSTT":"COMPLETED","EOSDT":"2022-03-03","EOSDY":731,"LSTALVDT":"2022-03-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":16,"AVALU":"WEEKS","ADTM":"2020-06-21 01:28:32","ADY":112,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-19 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05732,"AVALU":"YEARS","ADTM":"2020-06-08 23:50:48","ADY":21,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-20 23:50:48","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-05-20 23:50:48","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.42857,"AVALU":"WEEKS","ADTM":"2020-06-10 02:11:17","ADY":24,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-215","SUBJID":"id-215","SITEID":"NGA-4","AGE":40,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S1","BMRKR1":10.49773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-05-14","TRTSDTM":"2020-05-18 23:50:48","TRTEDTM":"2022-05-19 11:29:12","EOSSTT":"COMPLETED","EOSDT":"2022-05-19","EOSDY":731,"LSTALVDT":"2022-05-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":91.85714,"AVALU":"WEEKS","ADTM":"2022-02-19 14:37:00","ADY":643,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-08-18 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.10864,"AVALU":"YEARS","ADTM":"2020-09-26 19:54:13","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.73044,"AVALU":"YEARS","ADTM":"2021-05-11 19:54:13","ADY":267,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.27259,"AVALU":"YEARS","ADTM":"2020-11-25 19:54:13","ADY":100,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":97.57143,"AVALU":"WEEKS","ADTM":"2022-06-30 18:44:50","ADY":683,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-4-id-37","SUBJID":"id-37","SITEID":"NGA-4","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-4","INVNAM":"Dr. NGA-4 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Africa","STRATA1":"C","STRATA2":"S1","BMRKR1":4.57225,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 19:54:13","TRTEDTM":"2022-08-18 07:32:37","EOSSTT":"COMPLETED","EOSDT":"2022-08-18","EOSDY":731,"LSTALVDT":"2022-08-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":46,"AVALU":"WEEKS","ADTM":"2021-07-04 07:39:59","ADY":322,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-04 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.01254,"AVALU":"YEARS","ADTM":"2020-12-09 03:00:22","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06271,"AVALU":"YEARS","ADTM":"2020-12-27 03:00:22","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-12-05 03:00:22","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":1.71429,"AVALU":"WEEKS","ADTM":"2020-12-15 16:40:33","ADY":12,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-5-id-99","SUBJID":"id-99","SITEID":"NGA-5","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-5","INVNAM":"Dr. NGA-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"A","STRATA2":"S2","BMRKR1":5.48616,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-11-30","TRTSDTM":"2020-12-04 03:00:22","TRTEDTM":"2022-12-04 14:38:46","EOSSTT":"COMPLETED","EOSDT":"2022-12-04","EOSDY":731,"LSTALVDT":"2022-12-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":19.14286,"AVALU":"WEEKS","ADTM":"2021-04-16 00:52:59","ADY":134,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.87064,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":318,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.87064,"AVALU":"YEARS","ADTM":"2021-02-20 16:43:46","ADY":318,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.87064,"AVALU":"YEARS","ADTM":"2021-02-20 16:43:46","ADY":318,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05912,"AVALU":"YEARS","ADTM":"2020-04-30 16:43:46","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":48,"AVALU":"WEEKS","ADTM":"2021-03-09 10:32:38","ADY":336,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-NGA-6-id-363","SUBJID":"id-363","SITEID":"NGA-6","AGE":50,"SEX":"F","RACE":"ASIAN","COUNTRY":"NGA","DTHFL":"N","INVID":"INV ID NGA-6","INVNAM":"Dr. NGA-6 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Africa","STRATA1":"C","STRATA2":"S2","BMRKR1":4.17937,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-04-07","TRTSDTM":"2020-04-08 16:43:46","TRTEDTM":"2021-02-19 00:46:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":317,"DCSREAS":"LACK OF EFFICACY","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":53.85714,"AVALU":"WEEKS","ADTM":"2021-04-19 11:18:01","ADY":377,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-25 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.19512,"AVALU":"YEARS","ADTM":"2020-03-07 06:13:17","ADY":72,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.48739,"AVALU":"YEARS","ADTM":"2020-06-22 06:13:17","ADY":179,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16244,"AVALU":"YEARS","ADTM":"2020-02-24 06:13:17","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-12-26 06:13:17","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-112","SUBJID":"id-112","SITEID":"PAK-1","AGE":44,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":14.23741,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-26 06:13:17","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.57143,"AVALU":"WEEKS","ADTM":"2020-12-20 12:59:01","ADY":361,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-11 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-11-12 10:21:43","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.1208,"AVALU":"YEARS","ADTM":"2020-12-26 10:21:43","ADY":45,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01936,"AVALU":"YEARS","ADTM":"2020-11-19 10:21:43","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":92.57143,"AVALU":"WEEKS","ADTM":"2022-08-20 10:49:42","ADY":648,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-125","SUBJID":"id-125","SITEID":"PAK-1","AGE":49,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":6.63963,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-09","TRTSDTM":"2020-11-11 10:21:43","TRTEDTM":"2022-11-11 22:00:07","EOSSTT":"COMPLETED","EOSDT":"2022-11-11","EOSDY":731,"LSTALVDT":"2022-12-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":4,"AVALU":"WEEKS","ADTM":"2020-12-08 06:20:53","ADY":28,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-17 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-18 13:35:56","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.4096,"AVALU":"YEARS","ADTM":"2019-11-14 13:35:56","ADY":150,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04271,"AVALU":"YEARS","ADTM":"2019-07-03 13:35:56","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":62.28571,"AVALU":"WEEKS","ADTM":"2020-08-25 00:42:03","ADY":436,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-148","SUBJID":"id-148","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.39563,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-06-16","TRTSDTM":"2019-06-17 13:35:56","TRTEDTM":"2021-06-17 01:14:20","EOSSTT":"COMPLETED","EOSDT":"2021-06-17","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":74.71429,"AVALU":"WEEKS","ADTM":"2020-11-20 09:35:42","ADY":523,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-14 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.29395,"AVALU":"YEARS","ADTM":"2020-03-02 13:32:02","ADY":108,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20624,"AVALU":"YEARS","ADTM":"2020-01-30 13:32:02","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04562,"AVALU":"YEARS","ADTM":"2019-12-02 13:32:02","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.14286,"AVALU":"WEEKS","ADTM":"2020-10-02 19:01:12","ADY":323,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-169","SUBJID":"id-169","SITEID":"PAK-1","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.87444,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-12","TRTSDTM":"2019-11-15 13:32:02","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":2.85714,"AVALU":"WEEKS","ADTM":"2019-12-04 04:16:28","ADY":20,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-11 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.13229,"AVALU":"YEARS","ADTM":"2019-08-30 00:59:13","ADY":49,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.54527,"AVALU":"YEARS","ADTM":"2020-01-28 00:59:13","ADY":200,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.04366,"AVALU":"YEARS","ADTM":"2019-07-28 00:59:13","ADY":16,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":36.14286,"AVALU":"WEEKS","ADTM":"2020-03-20 04:29:50","ADY":253,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-17","SUBJID":"id-17","SITEID":"PAK-1","AGE":33,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":9.27195,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-07-08","TRTSDTM":"2019-07-12 00:59:13","TRTEDTM":"2021-07-11 12:37:37","EOSSTT":"COMPLETED","EOSDT":"2021-07-11","EOSDY":731,"LSTALVDT":"2021-07-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":100.71429,"AVALU":"WEEKS","ADTM":"2021-06-15 06:51:54","ADY":705,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-06-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.13178,"AVALU":"YEARS","ADTM":"2019-07-25 02:44:01","ADY":49,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-06-06 02:44:01","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16066,"AVALU":"YEARS","ADTM":"2019-08-04 02:44:01","ADY":59,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":74.71429,"AVALU":"WEEKS","ADTM":"2020-11-09 19:25:30","ADY":523,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-178","SUBJID":"id-178","SITEID":"PAK-1","AGE":46,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":5.32131,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-06 02:44:01","TRTEDTM":"2021-06-05 14:22:25","EOSSTT":"COMPLETED","EOSDT":"2021-06-05","EOSDY":731,"LSTALVDT":"2021-06-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":6,"AVALU":"WEEKS","ADTM":"2019-07-17 09:02:24","ADY":42,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-28 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-29 21:27:15","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.19088,"AVALU":"YEARS","ADTM":"2019-08-06 21:27:15","ADY":70,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1871,"AVALU":"YEARS","ADTM":"2019-08-05 21:27:15","ADY":69,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":64.42857,"AVALU":"WEEKS","ADTM":"2020-08-20 19:43:03","ADY":451,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-280","SUBJID":"id-280","SITEID":"PAK-1","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.96261,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-05-26","TRTSDTM":"2019-05-28 21:27:15","TRTEDTM":"2021-05-28 09:05:39","EOSSTT":"COMPLETED","EOSDT":"2021-05-28","EOSDY":731,"LSTALVDT":"2021-06-14","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":60,"AVALU":"WEEKS","ADTM":"2020-07-20 08:38:25","ADY":420,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-06 06:39:59","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23429,"AVALU":"YEARS","ADTM":"2020-10-30 06:39:59","ADY":86,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.13795,"AVALU":"YEARS","ADTM":"2020-09-25 06:39:59","ADY":51,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":55.42857,"AVALU":"WEEKS","ADTM":"2021-08-27 06:15:35","ADY":388,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-39","SUBJID":"id-39","SITEID":"PAK-1","AGE":36,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":4.56183,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-01","TRTSDTM":"2020-08-05 06:39:59","TRTEDTM":"2022-08-05 18:18:23","EOSSTT":"COMPLETED","EOSDT":"2022-08-05","EOSDY":731,"LSTALVDT":"2022-08-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":40.57143,"AVALU":"WEEKS","ADTM":"2021-05-15 23:32:35","ADY":284,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-21 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.2474,"AVALU":"YEARS","ADTM":"2020-02-21 02:57:26","ADY":91,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23222,"AVALU":"YEARS","ADTM":"2020-02-15 02:57:26","ADY":85,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08166,"AVALU":"YEARS","ADTM":"2019-12-22 02:57:26","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":47.14286,"AVALU":"WEEKS","ADTM":"2020-10-16 10:28:55","ADY":330,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-79","SUBJID":"id-79","SITEID":"PAK-1","AGE":37,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.7217,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-11-18","TRTSDTM":"2019-11-22 02:57:26","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":27.85714,"AVALU":"WEEKS","ADTM":"2020-06-03 21:20:48","ADY":195,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.80972,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":661,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.80972,"AVALU":"YEARS","ADTM":"2021-02-20 02:18:07","ADY":661,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.80972,"AVALU":"YEARS","ADTM":"2021-02-20 02:18:07","ADY":661,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18927,"AVALU":"YEARS","ADTM":"2019-07-10 02:18:07","ADY":70,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":83,"AVALU":"WEEKS","ADTM":"2020-12-01 03:40:09","ADY":581,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-1-id-95","SUBJID":"id-95","SITEID":"PAK-1","AGE":28,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-1","INVNAM":"Dr. PAK-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.88673,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-01 02:18:07","TRTEDTM":"2021-02-19 02:55:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":661,"DCSREAS":"DEATH","DTHDT":"2021-03-06","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":15,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":9.42857,"AVALU":"WEEKS","ADTM":"2019-07-05 08:56:43","ADY":66,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.16728,"AVALU":"YEARS","ADTM":"2020-03-19 15:05:28","ADY":62,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-17 15:05:28","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-17 15:05:28","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":100.57143,"AVALU":"WEEKS","ADTM":"2021-12-20 18:48:46","ADY":704,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-145","SUBJID":"id-145","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":8.20279,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-17","TRTSDTM":"2020-01-17 15:05:28","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":61.57143,"AVALU":"WEEKS","ADTM":"2021-03-22 03:28:20","ADY":431,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.14168,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":417,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.14168,"AVALU":"YEARS","ADTM":"2021-02-13 02:06:20","ADY":417,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.43343,"AVALU":"YEARS","ADTM":"2020-05-31 02:06:20","ADY":159,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.10692,"AVALU":"YEARS","ADTM":"2020-02-02 02:06:20","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":45.85714,"AVALU":"WEEKS","ADTM":"2020-11-08 06:07:19","ADY":321,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-187","SUBJID":"id-187","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.3773,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-21","TRTSDTM":"2019-12-24 02:06:20","TRTEDTM":"2021-02-12 13:29:27","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":417,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-02-24","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":45.28571,"AVALU":"WEEKS","ADTM":"2020-11-04 17:42:08","ADY":317,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17875,"AVALU":"YEARS","ADTM":"2019-11-30 15:46:57","ADY":66,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.36259,"AVALU":"YEARS","ADTM":"2020-02-05 15:46:57","ADY":133,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-25 15:46:57","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":103.71429,"AVALU":"WEEKS","ADTM":"2021-09-19 04:11:08","ADY":726,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-210","SUBJID":"id-210","SITEID":"PAK-11","AGE":23,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.6416,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-09-25","TRTSDTM":"2019-09-25 15:46:57","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":1.14286,"AVALU":"WEEKS","ADTM":"2019-10-02 03:16:43","ADY":8,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.92197,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":702,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.92197,"AVALU":"YEARS","ADTM":"2021-02-20 23:53:00","ADY":702,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.92197,"AVALU":"YEARS","ADTM":"2021-02-20 23:53:00","ADY":702,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.2518,"AVALU":"YEARS","ADTM":"2019-06-21 23:53:00","ADY":92,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":62.71429,"AVALU":"WEEKS","ADTM":"2020-06-01 11:02:01","ADY":439,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-268","SUBJID":"id-268","SITEID":"PAK-11","AGE":28,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":2.82014,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-21","TRTSDTM":"2019-03-21 23:53:00","TRTEDTM":"2021-02-19 08:04:31","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":701,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":17,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-03-21 23:53:00","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.08693,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":397,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.1262,"AVALU":"YEARS","ADTM":"2020-03-02 08:55:07","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23206,"AVALU":"YEARS","ADTM":"2020-04-09 08:55:07","ADY":85,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.17706,"AVALU":"YEARS","ADTM":"2020-03-20 08:55:07","ADY":65,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":59.14286,"AVALU":"WEEKS","ADTM":"2021-03-03 09:03:45","ADY":414,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-330","SUBJID":"id-330","SITEID":"PAK-11","AGE":32,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":6.69531,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-13","TRTSDTM":"2020-01-15 08:55:07","TRTEDTM":"2021-02-14 19:39:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":397,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":63.28571,"AVALU":"WEEKS","ADTM":"2021-04-01 07:50:29","ADY":443,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-24 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-25 09:51:12","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.33397,"AVALU":"YEARS","ADTM":"2020-04-25 09:51:12","ADY":122,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.12839,"AVALU":"YEARS","ADTM":"2020-02-10 09:51:12","ADY":47,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":49.85714,"AVALU":"WEEKS","ADTM":"2020-12-07 03:26:46","ADY":349,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-49","SUBJID":"id-49","SITEID":"PAK-11","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.14573,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-24","TRTSDTM":"2019-12-25 09:51:12","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":37.42857,"AVALU":"WEEKS","ADTM":"2020-09-11 03:21:14","ADY":262,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.71937,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":628,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.71937,"AVALU":"YEARS","ADTM":"2021-02-20 16:29:57","ADY":628,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.39768,"AVALU":"YEARS","ADTM":"2019-10-27 16:29:57","ADY":146,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.49622,"AVALU":"YEARS","ADTM":"2019-12-02 16:29:57","ADY":182,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":11.14286,"AVALU":"WEEKS","ADTM":"2019-08-19 13:10:48","ADY":78,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-68","SUBJID":"id-68","SITEID":"PAK-11","AGE":37,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S1","BMRKR1":5.24086,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-02","TRTSDTM":"2019-06-03 16:29:57","TRTEDTM":"2021-02-19 10:32:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":627,"DCSREAS":"DEATH","DTHDT":"2021-03-23","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":32,"LDDTHGR1":">30","LSTALVDT":"2021-03-23","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-06-03 16:29:57","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-10-19 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.23471,"AVALU":"YEARS","ADTM":"2021-01-12 15:37:19","ADY":86,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07464,"AVALU":"YEARS","ADTM":"2020-11-15 15:37:19","ADY":28,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05918,"AVALU":"YEARS","ADTM":"2020-11-09 15:37:19","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":81.28571,"AVALU":"WEEKS","ADTM":"2022-05-09 09:55:13","ADY":569,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-82","SUBJID":"id-82","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.98363,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-16","TRTSDTM":"2020-10-18 15:37:19","TRTEDTM":"2022-10-19 03:15:43","EOSSTT":"COMPLETED","EOSDT":"2022-10-19","EOSDY":731,"LSTALVDT":"2022-11-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":97,"AVALU":"WEEKS","ADTM":"2022-08-27 04:59:00","ADY":679,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.28998,"AVALU":"YEARS","ADTM":"2019-11-04 00:15:49","ADY":106,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03769,"AVALU":"YEARS","ADTM":"2019-08-04 00:15:49","ADY":14,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.4229,"AVALU":"YEARS","ADTM":"2019-12-23 00:15:49","ADY":155,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":70.57143,"AVALU":"WEEKS","ADTM":"2020-11-25 01:56:15","ADY":494,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-11-id-87","SUBJID":"id-87","SITEID":"PAK-11","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-11","INVNAM":"Dr. PAK-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":13.47621,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-19","TRTSDTM":"2019-07-21 00:15:49","TRTEDTM":"2021-07-20 11:54:13","EOSSTT":"COMPLETED","EOSDT":"2021-07-20","EOSDY":731,"LSTALVDT":"2021-08-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":91.71429,"AVALU":"WEEKS","ADTM":"2021-04-22 10:30:57","ADY":642,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":11} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11115,"AVALU":"YEARS","ADTM":"2019-10-21 10:42:42","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.29727,"AVALU":"YEARS","ADTM":"2019-12-28 10:42:42","ADY":109,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05085,"AVALU":"YEARS","ADTM":"2019-09-29 10:42:42","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":12.71429,"AVALU":"WEEKS","ADTM":"2019-12-07 04:02:24","ADY":89,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-328","SUBJID":"id-328","SITEID":"PAK-12","AGE":21,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":9.04077,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-09-10","TRTSDTM":"2019-09-10 10:42:42","TRTEDTM":"2021-09-09 22:21:06","EOSSTT":"COMPLETED","EOSDT":"2021-09-09","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":23.57143,"AVALU":"WEEKS","ADTM":"2020-02-21 11:41:51","ADY":165,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.44901,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":164,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.44901,"AVALU":"YEARS","ADTM":"2021-02-20 03:50:09","ADY":164,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0541,"AVALU":"YEARS","ADTM":"2020-09-29 03:50:09","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.30789,"AVALU":"YEARS","ADTM":"2020-12-31 03:50:09","ADY":113,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":78.85714,"AVALU":"WEEKS","ADTM":"2022-03-14 18:07:18","ADY":552,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-12-id-85","SUBJID":"id-85","SITEID":"PAK-12","AGE":31,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-12","INVNAM":"Dr. PAK-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.6978,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-06","TRTSDTM":"2020-09-09 03:50:09","TRTEDTM":"2021-02-19 22:17:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":164,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":35.28571,"AVALU":"WEEKS","ADTM":"2021-05-13 14:32:18","ADY":247,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-19 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-20 10:40:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-20 10:40:58","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.15146,"AVALU":"YEARS","ADTM":"2020-05-14 10:40:58","ADY":56,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":74,"AVALU":"WEEKS","ADTM":"2021-08-18 02:03:02","ADY":518,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-251","SUBJID":"id-251","SITEID":"PAK-13","AGE":32,"SEX":"M","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.6604,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-18","TRTSDTM":"2020-03-19 10:40:58","TRTEDTM":"2022-03-19 22:19:22","EOSSTT":"COMPLETED","EOSDT":"2022-03-19","EOSDY":731,"LSTALVDT":"2022-04-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":58.71429,"AVALU":"WEEKS","ADTM":"2021-05-03 00:16:28","ADY":411,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.24093,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":88,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.09202,"AVALU":"YEARS","ADTM":"2020-12-28 06:47:07","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18709,"AVALU":"YEARS","ADTM":"2021-02-01 06:47:07","ADY":69,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24093,"AVALU":"YEARS","ADTM":"2021-02-20 06:47:07","ADY":88,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-11-24 06:47:07","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-13-id-350","SUBJID":"id-350","SITEID":"PAK-13","AGE":39,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-13","INVNAM":"Dr. PAK-13 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.71377,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-21","TRTSDTM":"2020-11-24 06:47:07","TRTEDTM":"2021-02-19 08:54:16","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":88,"DCSREAS":"WITHDRAWAL BY PARENT/GUARDIAN","LSTALVDT":"2021-03-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":30.14286,"AVALU":"WEEKS","ADTM":"2021-06-22 18:06:44","ADY":211,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-14 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-15 04:19:32","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02219,"AVALU":"YEARS","ADTM":"2019-07-24 04:19:32","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.28585,"AVALU":"YEARS","ADTM":"2019-10-28 04:19:32","ADY":105,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":61.71429,"AVALU":"WEEKS","ADTM":"2020-09-18 17:05:34","ADY":432,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-14-id-117","SUBJID":"id-117","SITEID":"PAK-14","AGE":25,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-14","INVNAM":"Dr. PAK-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":6.26523,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-07-11","TRTSDTM":"2019-07-15 04:19:32","TRTEDTM":"2021-07-14 15:57:56","EOSSTT":"COMPLETED","EOSDT":"2021-07-14","EOSDY":731,"LSTALVDT":"2021-08-02","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":99.57143,"AVALU":"WEEKS","ADTM":"2021-06-10 22:29:00","ADY":697,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-17 23:02:04","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.25558,"AVALU":"YEARS","ADTM":"2019-12-20 23:02:04","ADY":94,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0452,"AVALU":"YEARS","ADTM":"2019-10-04 23:02:04","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":54.14286,"AVALU":"WEEKS","ADTM":"2020-09-29 10:30:44","ADY":379,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-15-id-314","SUBJID":"id-314","SITEID":"PAK-15","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-15","INVNAM":"Dr. PAK-15 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"A","STRATA2":"S1","BMRKR1":3.51131,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-13","TRTSDTM":"2019-09-17 23:02:04","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":70.57143,"AVALU":"WEEKS","ADTM":"2021-01-22 03:48:55","ADY":494,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-12 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.13477,"AVALU":"YEARS","ADTM":"2020-05-01 10:32:42","ADY":50,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.01352,"AVALU":"YEARS","ADTM":"2020-03-17 10:32:42","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11914,"AVALU":"YEARS","ADTM":"2020-04-25 10:32:42","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":34.85714,"AVALU":"WEEKS","ADTM":"2020-11-10 23:57:47","ADY":244,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-188","SUBJID":"id-188","SITEID":"PAK-2","AGE":23,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":16.48767,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-11","TRTSDTM":"2020-03-12 10:32:42","TRTEDTM":"2022-03-12 22:11:06","EOSSTT":"COMPLETED","EOSDT":"2022-03-12","EOSDY":731,"LSTALVDT":"2022-04-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":64.71429,"AVALU":"WEEKS","ADTM":"2021-06-07 16:55:25","ADY":453,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.87543,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":685,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.87543,"AVALU":"YEARS","ADTM":"2021-02-20 17:14:33","ADY":685,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09807,"AVALU":"YEARS","ADTM":"2019-05-13 17:14:33","ADY":36,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.03546,"AVALU":"YEARS","ADTM":"2019-04-20 17:14:33","ADY":13,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":43.42857,"AVALU":"WEEKS","ADTM":"2020-02-04 09:25:56","ADY":304,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-191","SUBJID":"id-191","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.14369,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-04-03","TRTSDTM":"2019-04-07 17:14:33","TRTEDTM":"2021-02-19 05:02:59","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":684,"DCSREAS":"PHYSICIAN DECISION","LSTALVDT":"2021-03-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":80.14286,"AVALU":"WEEKS","ADTM":"2020-10-18 12:15:48","ADY":561,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-15 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.39494,"AVALU":"YEARS","ADTM":"2020-06-09 13:25:18","ADY":145,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08526,"AVALU":"YEARS","ADTM":"2020-02-17 13:25:18","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16559,"AVALU":"YEARS","ADTM":"2020-03-17 13:25:18","ADY":61,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":66.28571,"AVALU":"WEEKS","ADTM":"2021-04-23 04:46:02","ADY":464,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-2-id-213","SUBJID":"id-213","SITEID":"PAK-2","AGE":38,"SEX":"F","RACE":"WHITE","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-2","INVNAM":"Dr. PAK-2 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.81794,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-13","TRTSDTM":"2020-01-16 13:25:18","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":22.71429,"AVALU":"WEEKS","ADTM":"2020-06-22 05:30:06","ADY":159,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.14168,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":417,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.30103,"AVALU":"YEARS","ADTM":"2020-04-15 05:34:07","ADY":110,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.14168,"AVALU":"YEARS","ADTM":"2021-02-16 05:34:07","ADY":417,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.19232,"AVALU":"YEARS","ADTM":"2020-03-07 05:34:07","ADY":71,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":29,"AVALU":"WEEKS","ADTM":"2020-07-16 06:24:31","ADY":203,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-15","SUBJID":"id-15","SITEID":"PAK-4","AGE":30,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":8.81159,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-12-25","TRTSDTM":"2019-12-27 05:34:07","TRTEDTM":"2021-02-15 18:46:22","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":417,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":10,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":53.42857,"AVALU":"WEEKS","ADTM":"2021-01-03 12:15:17","ADY":374,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-11-29 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.60234,"AVALU":"YEARS","ADTM":"2020-07-08 22:18:59","ADY":221,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.62415,"AVALU":"YEARS","ADTM":"2020-07-15 22:18:59","ADY":228,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05568,"AVALU":"YEARS","ADTM":"2019-12-21 22:18:59","ADY":21,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":100.14286,"AVALU":"WEEKS","ADTM":"2021-10-30 03:21:32","ADY":701,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-4-id-164","SUBJID":"id-164","SITEID":"PAK-4","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"N","INVID":"INV ID PAK-4","INVNAM":"Dr. PAK-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Asia","STRATA1":"B","STRATA2":"S1","BMRKR1":1.8305,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-11-27","TRTSDTM":"2019-11-30 22:18:59","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-11-30 22:18:59","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.40794,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":149,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.40794,"AVALU":"YEARS","ADTM":"2021-02-17 06:20:20","ADY":149,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.12585,"AVALU":"YEARS","ADTM":"2020-11-06 06:20:20","ADY":46,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.22725,"AVALU":"YEARS","ADTM":"2020-12-14 06:20:20","ADY":84,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":28,"AVALU":"WEEKS","ADTM":"2021-04-04 04:53:45","ADY":196,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-PAK-5-id-20","SUBJID":"id-20","SITEID":"PAK-5","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"PAK","DTHFL":"Y","INVID":"INV ID PAK-5","INVNAM":"Dr. PAK-5 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Asia","STRATA1":"A","STRATA2":"S2","BMRKR1":5.84789,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-09-20","TRTSDTM":"2020-09-21 06:20:20","TRTEDTM":"2021-02-16 00:00:02","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":148,"DCSREAS":"DEATH","DTHDT":"2021-03-19","DTHCAUS":"LOST TO FOLLOW UP","DTHCAT":"OTHER","LDDTHELD":31,"LDDTHGR1":">30","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":1.42857,"AVALU":"WEEKS","ADTM":"2020-09-30 10:24:17","ADY":10,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-18 09:38:09","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.00483,"AVALU":"YEARS","ADTM":"2019-03-20 09:38:09","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05763,"AVALU":"YEARS","ADTM":"2019-04-09 09:38:09","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":82.71429,"AVALU":"WEEKS","ADTM":"2020-10-16 09:55:05","ADY":579,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-1-id-52","SUBJID":"id-52","SITEID":"RUS-1","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-1","INVNAM":"Dr. RUS-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":7.20635,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-17","TRTSDTM":"2019-03-18 09:38:09","TRTEDTM":"2021-03-17 21:16:33","EOSSTT":"COMPLETED","EOSDT":"2021-03-17","EOSDY":731,"LSTALVDT":"2021-04-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":35.14286,"AVALU":"WEEKS","ADTM":"2019-11-18 03:47:59","ADY":246,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.88433,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":323,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06836,"AVALU":"YEARS","ADTM":"2020-04-24 21:07:56","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.52667,"AVALU":"YEARS","ADTM":"2020-10-09 21:07:56","ADY":193,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.53107,"AVALU":"YEARS","ADTM":"2020-10-10 21:07:56","ADY":194,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":22.57143,"AVALU":"WEEKS","ADTM":"2020-09-03 19:19:01","ADY":158,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-162","SUBJID":"id-162","SITEID":"RUS-11","AGE":37,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":8.34705,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-30","TRTSDTM":"2020-03-30 21:07:56","TRTEDTM":"2021-02-15 18:54:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":322,"DCSREAS":"DEATH","DTHDT":"2021-02-27","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":12,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":44.14286,"AVALU":"WEEKS","ADTM":"2021-02-01 06:39:03","ADY":309,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.57221,"AVALU":"YEARS","ADTM":"2021-02-16 00:00:00","ADY":209,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.11954,"AVALU":"YEARS","ADTM":"2020-09-05 11:33:53","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.19556,"AVALU":"YEARS","ADTM":"2020-10-03 11:33:53","ADY":72,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0607,"AVALU":"YEARS","ADTM":"2020-08-15 11:33:53","ADY":23,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-07-23 11:33:53","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-283","SUBJID":"id-283","SITEID":"RUS-11","AGE":37,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.78881,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-07-19","TRTSDTM":"2020-07-23 11:33:53","TRTEDTM":"2021-02-16 17:24:37","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-16","EOSDY":209,"DCSREAS":"DEATH","DTHDT":"2021-03-01","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":13,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":84.28571,"AVALU":"WEEKS","ADTM":"2022-03-04 21:23:52","ADY":590,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-11 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-12 14:34:22","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-12 14:34:22","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24056,"AVALU":"YEARS","ADTM":"2019-11-07 14:34:22","ADY":88,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":63.71429,"AVALU":"WEEKS","ADTM":"2020-10-29 21:28:13","ADY":446,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-76","SUBJID":"id-76","SITEID":"RUS-11","AGE":25,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.74484,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-11 14:34:22","TRTEDTM":"2021-08-11 02:12:46","EOSSTT":"COMPLETED","EOSDT":"2021-08-11","EOSDY":731,"LSTALVDT":"2021-08-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-08-11 14:34:22","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-23 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-24 21:12:31","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0881,"AVALU":"YEARS","ADTM":"2019-09-25 21:12:31","ADY":33,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.32048,"AVALU":"YEARS","ADTM":"2019-12-19 21:12:31","ADY":118,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":61.42857,"AVALU":"WEEKS","ADTM":"2020-10-25 02:26:39","ADY":430,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-11-id-94","SUBJID":"id-94","SITEID":"RUS-11","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-11","INVNAM":"Dr. RUS-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":9.31688,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-19","TRTSDTM":"2019-08-23 21:12:31","TRTEDTM":"2021-08-23 08:50:55","EOSSTT":"COMPLETED","EOSDT":"2021-08-23","EOSDY":731,"LSTALVDT":"2021-09-04","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":97.85714,"AVALU":"WEEKS","ADTM":"2021-07-07 19:03:45","ADY":685,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-07 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-08 11:10:29","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.06867,"AVALU":"YEARS","ADTM":"2020-01-03 11:10:29","ADY":26,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14678,"AVALU":"YEARS","ADTM":"2020-01-31 11:10:29","ADY":54,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":54.28571,"AVALU":"WEEKS","ADTM":"2020-12-21 06:34:38","ADY":380,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-12-id-185","SUBJID":"id-185","SITEID":"RUS-12","AGE":31,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-12","INVNAM":"Dr. RUS-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":7.67625,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-12-04","TRTSDTM":"2019-12-08 11:10:29","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":62.42857,"AVALU":"WEEKS","ADTM":"2021-02-16 13:21:37","ADY":437,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.85352,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":677,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.79011,"AVALU":"YEARS","ADTM":"2020-01-29 01:37:57","ADY":289,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.85352,"AVALU":"YEARS","ADTM":"2021-02-20 01:37:57","ADY":677,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02422,"AVALU":"YEARS","ADTM":"2019-04-24 01:37:57","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":7.71429,"AVALU":"WEEKS","ADTM":"2019-06-07 16:21:58","ADY":54,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-13-id-70","SUBJID":"id-70","SITEID":"RUS-13","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-13","INVNAM":"Dr. RUS-13 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.48732,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-15","TRTSDTM":"2019-04-15 01:37:57","TRTEDTM":"2021-02-19 03:05:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":677,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-03","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.85714,"AVALU":"WEEKS","ADTM":"2019-04-20 16:04:32","ADY":6,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-27 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":12} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00136,"AVALU":"YEARS","ADTM":"2019-08-28 22:58:57","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.53617,"AVALU":"YEARS","ADTM":"2020-03-10 22:58:57","ADY":196,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06399,"AVALU":"YEARS","ADTM":"2019-09-20 22:58:57","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":56,"AVALU":"WEEKS","ADTM":"2020-09-21 02:37:10","ADY":392,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-14-id-183","SUBJID":"id-183","SITEID":"RUS-14","AGE":28,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-14","INVNAM":"Dr. RUS-14 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":4.19605,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-08-23","TRTSDTM":"2019-08-27 22:58:57","TRTEDTM":"2021-08-27 10:37:21","EOSSTT":"COMPLETED","EOSDT":"2021-08-27","EOSDY":731,"LSTALVDT":"2021-09-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":101.71429,"AVALU":"WEEKS","ADTM":"2021-08-07 07:35:00","ADY":712,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-07 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.70774,"AVALU":"YEARS","ADTM":"2021-03-22 15:36:55","ADY":259,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.1484,"AVALU":"YEARS","ADTM":"2020-08-30 15:36:55","ADY":55,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-08 15:36:55","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":95.57143,"AVALU":"WEEKS","ADTM":"2022-05-05 08:55:06","ADY":669,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-165","SUBJID":"id-165","SITEID":"RUS-16","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S2","BMRKR1":3.49284,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-07-04","TRTSDTM":"2020-07-06 15:36:55","TRTEDTM":"2022-07-07 03:15:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-07","EOSDY":731,"LSTALVDT":"2022-08-05","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":37.42857,"AVALU":"WEEKS","ADTM":"2021-03-24 03:28:13","ADY":262,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.90075,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":329,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.27204,"AVALU":"YEARS","ADTM":"2020-07-06 03:49:22","ADY":100,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.21247,"AVALU":"YEARS","ADTM":"2020-06-14 03:49:22","ADY":78,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.57904,"AVALU":"YEARS","ADTM":"2020-10-26 03:49:22","ADY":212,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":74.57143,"AVALU":"WEEKS","ADTM":"2021-08-31 03:30:57","ADY":522,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-16-id-4","SUBJID":"id-4","SITEID":"RUS-16","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-16","INVNAM":"Dr. RUS-16 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":12.7694,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-25","TRTSDTM":"2020-03-28 03:49:22","TRTEDTM":"2021-02-19 13:01:40","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":329,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-03-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":74.28571,"AVALU":"WEEKS","ADTM":"2021-08-29 17:34:55","ADY":520,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-08 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05086,"AVALU":"YEARS","ADTM":"2019-06-27 15:01:32","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.011,"AVALU":"YEARS","ADTM":"2019-06-13 15:01:32","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.31284,"AVALU":"YEARS","ADTM":"2019-10-01 15:01:32","ADY":115,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":16.42857,"AVALU":"WEEKS","ADTM":"2019-09-30 20:23:15","ADY":115,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-18-id-359","SUBJID":"id-359","SITEID":"RUS-18","AGE":47,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-18","INVNAM":"Dr. RUS-18 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S1","BMRKR1":4.42016,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2019-06-06","TRTSDTM":"2019-06-08 15:01:32","TRTEDTM":"2021-06-08 02:39:56","EOSSTT":"COMPLETED","EOSDT":"2021-06-08","EOSDY":731,"LSTALVDT":"2021-06-27","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":10.85714,"AVALU":"WEEKS","ADTM":"2019-08-22 05:14:49","ADY":76,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-13 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.31234,"AVALU":"YEARS","ADTM":"2020-08-05 13:36:33","ADY":115,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.73033,"AVALU":"YEARS","ADTM":"2021-01-04 13:36:33","ADY":267,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-14 13:36:33","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":48.14286,"AVALU":"WEEKS","ADTM":"2021-03-14 20:24:16","ADY":337,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-2-id-176","SUBJID":"id-176","SITEID":"RUS-2","AGE":42,"SEX":"F","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-2","INVNAM":"Dr. RUS-2 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":5.65962,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-04-12","TRTSDTM":"2020-04-12 13:36:33","TRTEDTM":"2022-04-13 01:14:57","EOSSTT":"COMPLETED","EOSDT":"2022-04-13","EOSDY":731,"LSTALVDT":"2022-05-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":80.42857,"AVALU":"WEEKS","ADTM":"2021-10-26 16:16:23","ADY":563,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-02-28 03:19:08","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.1417,"AVALU":"YEARS","ADTM":"2019-04-21 03:19:08","ADY":52,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07886,"AVALU":"YEARS","ADTM":"2019-03-29 03:19:08","ADY":29,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":90.57143,"AVALU":"WEEKS","ADTM":"2020-11-22 09:46:59","ADY":634,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-3-id-378","SUBJID":"id-378","SITEID":"RUS-3","AGE":30,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-3","INVNAM":"Dr. RUS-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":2.80324,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-02-24","TRTSDTM":"2019-02-28 03:19:08","TRTEDTM":"2021-02-27 14:57:32","EOSSTT":"COMPLETED","EOSDT":"2021-02-27","EOSDY":731,"LSTALVDT":"2021-03-15","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-02-28 03:19:08","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-03-09 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.22715,"AVALU":"YEARS","ADTM":"2020-05-31 04:38:37","ADY":83,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.6446,"AVALU":"YEARS","ADTM":"2020-10-31 04:38:37","ADY":236,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.30212,"AVALU":"YEARS","ADTM":"2020-06-28 04:38:37","ADY":111,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":14.57143,"AVALU":"WEEKS","ADTM":"2020-06-18 15:11:18","ADY":102,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-150","SUBJID":"id-150","SITEID":"RUS-4","AGE":29,"SEX":"M","RACE":"WHITE","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S1","BMRKR1":3.31455,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-09 04:38:37","TRTEDTM":"2022-03-09 16:17:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-09","EOSDY":731,"LSTALVDT":"2022-03-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":62.14286,"AVALU":"WEEKS","ADTM":"2021-05-17 02:19:13","ADY":435,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-06-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-06-21 02:04:42","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03066,"AVALU":"YEARS","ADTM":"2019-07-03 02:04:42","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.34573,"AVALU":"YEARS","ADTM":"2019-10-26 02:04:42","ADY":127,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":10,"AVALU":"WEEKS","ADTM":"2019-08-29 18:11:19","ADY":70,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-180","SUBJID":"id-180","SITEID":"RUS-4","AGE":31,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"A","STRATA2":"S1","BMRKR1":1.62272,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-17","TRTSDTM":"2019-06-21 02:04:42","TRTEDTM":"2021-06-20 13:43:06","EOSSTT":"COMPLETED","EOSDT":"2021-06-20","EOSDY":731,"LSTALVDT":"2021-07-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":8.28571,"AVALU":"WEEKS","ADTM":"2019-08-17 18:37:31","ADY":58,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-03 01:00:32","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.25345,"AVALU":"YEARS","ADTM":"2019-07-05 01:00:32","ADY":93,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02333,"AVALU":"YEARS","ADTM":"2019-04-12 01:00:32","ADY":9,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":30.85714,"AVALU":"WEEKS","ADTM":"2019-11-04 00:31:45","ADY":216,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-4-id-6","SUBJID":"id-6","SITEID":"RUS-4","AGE":44,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-4","INVNAM":"Dr. RUS-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":4.9442,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-31","TRTSDTM":"2019-04-03 01:00:32","TRTEDTM":"2021-04-02 12:38:56","EOSSTT":"COMPLETED","EOSDT":"2021-04-02","EOSDY":731,"LSTALVDT":"2021-04-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":66.71429,"AVALU":"WEEKS","ADTM":"2020-07-12 04:02:19","ADY":467,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.19986,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":73,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.18777,"AVALU":"YEARS","ADTM":"2021-02-15 00:51:06","ADY":69,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18405,"AVALU":"YEARS","ADTM":"2021-02-14 00:51:06","ADY":68,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.01345,"AVALU":"YEARS","ADTM":"2020-12-13 00:51:06","ADY":5,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":44.57143,"AVALU":"WEEKS","ADTM":"2021-10-15 16:18:34","ADY":312,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-5-id-29","SUBJID":"id-29","SITEID":"RUS-5","AGE":58,"SEX":"M","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-5","INVNAM":"Dr. RUS-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":2.11508,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-12-05","TRTSDTM":"2020-12-08 00:51:06","TRTEDTM":"2021-02-18 07:21:56","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":73,"DCSREAS":"DEATH","DTHDT":"2021-03-12","DTHCAUS":"DISEASE PROGRESSION","DTHCAT":"PROGRESSIVE DISEASE","LDDTHELD":22,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":83.71429,"AVALU":"WEEKS","ADTM":"2022-07-16 15:35:47","ADY":586,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.23819,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":87,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.23819,"AVALU":"YEARS","ADTM":"2021-02-19 20:51:59","ADY":87,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23819,"AVALU":"YEARS","ADTM":"2021-02-19 20:51:59","ADY":87,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.23819,"AVALU":"YEARS","ADTM":"2021-02-19 20:51:59","ADY":87,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.57143,"AVALU":"WEEKS","ADTM":"2021-10-15 16:05:34","ADY":326,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-6-id-77","SUBJID":"id-77","SITEID":"RUS-6","AGE":26,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"RUS","DTHFL":"N","INVID":"INV ID RUS-6","INVNAM":"Dr. RUS-6 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"Eurasia","STRATA1":"B","STRATA2":"S2","BMRKR1":5.81259,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-11-23","TRTSDTM":"2020-11-24 20:51:59","TRTEDTM":"2021-02-18 16:03:35","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":86,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-04","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":55,"AVALU":"WEEKS","ADTM":"2021-12-13 22:22:51","ADY":385,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.06571,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":24,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06571,"AVALU":"YEARS","ADTM":"2021-02-16 07:44:03","ADY":24,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.0485,"AVALU":"YEARS","ADTM":"2021-02-10 07:44:03","ADY":18,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00396,"AVALU":"YEARS","ADTM":"2021-01-25 07:44:03","ADY":2,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":39.71429,"AVALU":"WEEKS","ADTM":"2021-10-27 03:16:49","ADY":278,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-RUS-7-id-243","SUBJID":"id-243","SITEID":"RUS-7","AGE":27,"SEX":"F","RACE":"ASIAN","COUNTRY":"RUS","DTHFL":"Y","INVID":"INV ID RUS-7","INVNAM":"Dr. RUS-7 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"Eurasia","STRATA1":"C","STRATA2":"S2","BMRKR1":3.0318,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2021-01-22","TRTSDTM":"2021-01-23 07:44:03","TRTEDTM":"2021-02-15 10:18:55","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":24,"DCSREAS":"DEATH","DTHDT":"2021-03-26","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":39,"LDDTHGR1":">30","LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":39.42857,"AVALU":"WEEKS","ADTM":"2021-10-25 17:40:20","ADY":276,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.79055,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":654,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06346,"AVALU":"YEARS","ADTM":"2019-05-27 19:16:34","ADY":24,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":1.79055,"AVALU":"YEARS","ADTM":"2021-02-15 19:16:34","ADY":654,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.79055,"AVALU":"YEARS","ADTM":"2021-02-15 19:16:34","ADY":654,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":14.42857,"AVALU":"WEEKS","ADTM":"2019-08-11 08:03:28","ADY":101,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-137","SUBJID":"id-137","SITEID":"USA-1","AGE":29,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":3.40697,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-01","TRTSDTM":"2019-05-03 19:16:34","TRTEDTM":"2021-02-14 01:42:00","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":653,"DCSREAS":"DEATH","DTHDT":"2021-03-20","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":34,"LDDTHGR1":">30","LSTALVDT":"2021-03-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":5.14286,"AVALU":"WEEKS","ADTM":"2019-06-07 22:21:39","ADY":36,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.5065,"AVALU":"YEARS","ADTM":"2021-02-15 00:00:00","ADY":185,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04537,"AVALU":"YEARS","ADTM":"2020-09-01 02:53:55","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.15344,"AVALU":"YEARS","ADTM":"2020-10-11 02:53:55","ADY":57,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.31015,"AVALU":"YEARS","ADTM":"2020-12-07 02:53:55","ADY":114,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":46.14286,"AVALU":"WEEKS","ADTM":"2021-07-03 10:02:35","ADY":323,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-138","SUBJID":"id-138","SITEID":"USA-1","AGE":36,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.96586,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-08-14","TRTSDTM":"2020-08-15 02:53:55","TRTEDTM":"2021-02-15 03:28:47","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-15","EOSDY":185,"DCSREAS":"DEATH","DTHDT":"2021-03-08","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":21,"LDDTHGR1":"<=30","LSTALVDT":"2021-03-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":2.14286,"AVALU":"WEEKS","ADTM":"2020-08-29 15:10:15","ADY":15,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-15 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-16 21:07:26","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03094,"AVALU":"YEARS","ADTM":"2021-01-26 21:07:26","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-01-16 21:07:26","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":72.28571,"AVALU":"WEEKS","ADTM":"2022-06-03 06:24:00","ADY":506,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-207","SUBJID":"id-207","SITEID":"USA-1","AGE":38,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":5.30656,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2021-01-13","TRTSDTM":"2021-01-14 21:07:26","TRTEDTM":"2023-01-15 08:45:50","EOSSTT":"COMPLETED","EOSDT":"2023-01-15","EOSDY":731,"LSTALVDT":"2023-02-04","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":32.42857,"AVALU":"WEEKS","ADTM":"2021-08-28 20:29:34","ADY":227,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-04-27 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05158,"AVALU":"YEARS","ADTM":"2019-05-16 19:53:34","ADY":19,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.18967,"AVALU":"YEARS","ADTM":"2019-07-06 19:53:34","ADY":70,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.35949,"AVALU":"YEARS","ADTM":"2019-09-06 19:53:34","ADY":132,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":43.28571,"AVALU":"WEEKS","ADTM":"2020-02-23 17:49:21","ADY":303,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-242","SUBJID":"id-242","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":13.87859,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-25","TRTSDTM":"2019-04-27 19:53:34","TRTEDTM":"2021-04-27 07:31:58","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-09","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":82.57143,"AVALU":"WEEKS","ADTM":"2020-11-24 00:12:31","ADY":578,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-16 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05893,"AVALU":"YEARS","ADTM":"2020-10-07 14:45:32","ADY":22,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-09-17 14:45:32","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.02172,"AVALU":"YEARS","ADTM":"2020-09-23 14:45:32","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":51,"AVALU":"WEEKS","ADTM":"2021-09-06 01:01:42","ADY":357,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-254","SUBJID":"id-254","SITEID":"USA-1","AGE":28,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":2.65998,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-13","TRTSDTM":"2020-09-15 14:45:32","TRTEDTM":"2022-09-16 02:23:56","EOSSTT":"COMPLETED","EOSDT":"2022-09-16","EOSDY":731,"LSTALVDT":"2022-09-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":33.57143,"AVALU":"WEEKS","ADTM":"2021-05-07 16:47:21","ADY":235,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-03-06 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.14248,"AVALU":"YEARS","ADTM":"2019-04-28 17:20:55","ADY":53,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.09596,"AVALU":"YEARS","ADTM":"2019-04-11 17:20:55","ADY":36,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.1153,"AVALU":"YEARS","ADTM":"2019-04-18 17:20:55","ADY":43,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":7.57143,"AVALU":"WEEKS","ADTM":"2019-04-27 02:54:03","ADY":53,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-261","SUBJID":"id-261","SITEID":"USA-1","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":2.85516,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-03-02","TRTSDTM":"2019-03-06 17:20:55","TRTEDTM":"2021-03-06 04:59:19","EOSSTT":"COMPLETED","EOSDT":"2021-03-06","EOSDY":731,"LSTALVDT":"2021-03-26","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-03-06 17:20:55","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-05-16 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.28427,"AVALU":"YEARS","ADTM":"2019-08-29 11:11:50","ADY":104,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.20604,"AVALU":"YEARS","ADTM":"2019-08-01 11:11:50","ADY":76,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05719,"AVALU":"YEARS","ADTM":"2019-06-07 11:11:50","ADY":21,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":7,"AVALU":"WEEKS","ADTM":"2019-07-04 08:53:27","ADY":49,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-269","SUBJID":"id-269","SITEID":"USA-1","AGE":35,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.54767,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-16","TRTSDTM":"2019-05-17 11:11:50","TRTEDTM":"2021-05-16 22:50:14","EOSSTT":"COMPLETED","EOSDT":"2021-05-16","EOSDY":731,"LSTALVDT":"2021-06-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":40,"AVALU":"WEEKS","ADTM":"2020-02-20 20:23:32","ADY":280,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-09 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-10 23:44:24","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-08-10 23:44:24","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.5745,"AVALU":"YEARS","ADTM":"2020-03-06 23:44:24","ADY":210,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":57.28571,"AVALU":"WEEKS","ADTM":"2020-09-12 18:52:48","ADY":401,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-295","SUBJID":"id-295","SITEID":"USA-1","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.68619,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-08-07","TRTSDTM":"2019-08-09 23:44:24","TRTEDTM":"2021-08-09 11:22:48","EOSSTT":"COMPLETED","EOSDT":"2021-08-09","EOSDY":731,"LSTALVDT":"2021-09-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-08-09 23:44:24","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-12-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.39933,"AVALU":"YEARS","ADTM":"2020-05-12 19:14:01","ADY":146,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.63411,"AVALU":"YEARS","ADTM":"2020-08-06 19:14:01","ADY":232,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.06807,"AVALU":"YEARS","ADTM":"2020-01-12 19:14:01","ADY":25,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":43.28571,"AVALU":"WEEKS","ADTM":"2020-10-15 19:39:44","ADY":303,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-394","SUBJID":"id-394","SITEID":"USA-1","AGE":46,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":6.14556,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-14","TRTSDTM":"2019-12-18 19:14:01","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":4,"AVALU":"WEEKS","ADTM":"2020-01-14 13:52:10","ADY":28,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-03-05 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.02107,"AVALU":"YEARS","ADTM":"2019-03-14 06:32:04","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08128,"AVALU":"YEARS","ADTM":"2019-04-05 06:32:04","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.14162,"AVALU":"YEARS","ADTM":"2019-04-27 06:32:04","ADY":52,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":61,"AVALU":"WEEKS","ADTM":"2020-05-05 11:23:55","ADY":427,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-1-id-45","SUBJID":"id-45","SITEID":"USA-1","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-1","INVNAM":"Dr. USA-1 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":0.46356,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-03-04","TRTSDTM":"2019-03-06 06:32:04","TRTEDTM":"2021-03-05 18:10:28","EOSSTT":"COMPLETED","EOSDT":"2021-03-05","EOSDY":731,"LSTALVDT":"2021-03-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.85714,"AVALU":"WEEKS","ADTM":"2020-03-02 01:23:38","ADY":363,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-11 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.13507,"AVALU":"YEARS","ADTM":"2020-04-29 17:51:34","ADY":50,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-12 17:51:34","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-12 17:51:34","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":21.85714,"AVALU":"WEEKS","ADTM":"2020-08-09 13:09:36","ADY":153,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-100","SUBJID":"id-100","SITEID":"USA-11","AGE":40,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":6.64371,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-08","TRTSDTM":"2020-03-10 17:51:34","TRTEDTM":"2022-03-11 05:29:58","EOSSTT":"COMPLETED","EOSDT":"2022-03-11","EOSDY":731,"LSTALVDT":"2022-03-31","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":104,"AVALU":"WEEKS","ADTM":"2022-03-07 18:46:08","ADY":728,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-01 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-02 04:58:16","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.17536,"AVALU":"YEARS","ADTM":"2019-12-06 04:58:16","ADY":65,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-10-02 04:58:16","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":41.57143,"AVALU":"WEEKS","ADTM":"2020-07-18 02:14:49","ADY":291,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-136","SUBJID":"id-136","SITEID":"USA-11","AGE":38,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.57955,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-28","TRTSDTM":"2019-10-02 04:58:16","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":21.42857,"AVALU":"WEEKS","ADTM":"2020-02-28 00:21:41","ADY":150,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.68446,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":250,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08507,"AVALU":"YEARS","ADTM":"2020-07-16 21:02:32","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.10018,"AVALU":"YEARS","ADTM":"2020-07-21 21:02:32","ADY":37,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.68446,"AVALU":"YEARS","ADTM":"2021-02-19 21:02:32","ADY":250,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":83.14286,"AVALU":"WEEKS","ADTM":"2022-01-16 09:22:34","ADY":582,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-157","SUBJID":"id-157","SITEID":"USA-11","AGE":50,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":6.18035,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-06-14","TRTSDTM":"2020-06-14 21:02:32","TRTEDTM":"2021-02-18 23:02:58","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":250,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":44.14286,"AVALU":"WEEKS","ADTM":"2021-04-18 11:43:25","ADY":309,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.14442,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":418,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.14442,"AVALU":"YEARS","ADTM":"2021-02-19 09:26:17","ADY":418,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.27352,"AVALU":"YEARS","ADTM":"2020-04-07 09:26:17","ADY":100,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.18092,"AVALU":"YEARS","ADTM":"2020-03-05 09:26:17","ADY":67,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":68.28571,"AVALU":"WEEKS","ADTM":"2021-04-19 07:24:24","ADY":478,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-203","SUBJID":"id-203","SITEID":"USA-11","AGE":41,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":5.60082,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-12-26","TRTSDTM":"2019-12-29 09:26:17","TRTEDTM":"2021-02-18 00:40:06","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":417,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-07","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":49.71429,"AVALU":"WEEKS","ADTM":"2020-12-10 10:29:27","ADY":348,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-18 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-19 21:09:06","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.29295,"AVALU":"YEARS","ADTM":"2021-03-05 21:09:06","ADY":108,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.31389,"AVALU":"YEARS","ADTM":"2021-03-12 21:09:06","ADY":115,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":38.85714,"AVALU":"WEEKS","ADTM":"2021-08-15 17:00:32","ADY":272,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-224","SUBJID":"id-224","SITEID":"USA-11","AGE":36,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":6.42717,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-11-13","TRTSDTM":"2020-11-17 21:09:06","TRTEDTM":"2022-11-18 08:47:30","EOSSTT":"COMPLETED","EOSDT":"2022-11-18","EOSDY":731,"LSTALVDT":"2022-12-16","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":67.85714,"AVALU":"WEEKS","ADTM":"2022-03-06 07:21:28","ADY":475,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.17728,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":430,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.39062,"AVALU":"YEARS","ADTM":"2020-05-08 16:08:38","ADY":143,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.4093,"AVALU":"YEARS","ADTM":"2020-05-15 16:08:38","ADY":150,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.00691,"AVALU":"YEARS","ADTM":"2019-12-20 16:08:38","ADY":3,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.57143,"AVALU":"WEEKS","ADTM":"2020-01-10 09:28:28","ADY":25,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-238","SUBJID":"id-238","SITEID":"USA-11","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.0392,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-12-15","TRTSDTM":"2019-12-17 16:08:38","TRTEDTM":"2021-02-18 01:47:25","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":429,"DCSREAS":"WITHDRAWAL BY SUBJECT","LSTALVDT":"2021-02-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":85.71429,"AVALU":"WEEKS","ADTM":"2021-08-07 18:18:39","ADY":600,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-03-14 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.17676,"AVALU":"YEARS","ADTM":"2020-05-17 22:26:37","ADY":65,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.03012,"AVALU":"YEARS","ADTM":"2020-03-25 22:26:37","ADY":12,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.09232,"AVALU":"YEARS","ADTM":"2020-04-16 22:26:37","ADY":34,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":62.14286,"AVALU":"WEEKS","ADTM":"2021-05-21 11:27:00","ADY":435,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-32","SUBJID":"id-32","SITEID":"USA-11","AGE":24,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":8.45456,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-03-09","TRTSDTM":"2020-03-13 22:26:37","TRTEDTM":"2022-03-14 10:05:01","EOSSTT":"COMPLETED","EOSDT":"2022-03-14","EOSDY":731,"LSTALVDT":"2022-04-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":85.57143,"AVALU":"WEEKS","ADTM":"2021-11-01 15:51:11","ADY":599,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.32786,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":485,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":1} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07958,"AVALU":"YEARS","ADTM":"2019-11-18 19:38:18","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08322,"AVALU":"YEARS","ADTM":"2019-11-19 19:38:18","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.32786,"AVALU":"YEARS","ADTM":"2021-02-15 19:38:18","ADY":485,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":1.14286,"AVALU":"WEEKS","ADTM":"2019-10-26 17:05:12","ADY":8,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-339","SUBJID":"id-339","SITEID":"USA-11","AGE":39,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":17.21213,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-17","TRTSDTM":"2019-10-19 19:38:18","TRTEDTM":"2021-02-14 05:39:26","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":484,"DCSREAS":"ADVERSE EVENT","LSTALVDT":"2021-03-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":101,"AVALU":"WEEKS","ADTM":"2021-09-24 03:46:54","ADY":707,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-09 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":9} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.04527,"AVALU":"YEARS","ADTM":"2019-06-26 18:20:19","ADY":17,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.22147,"AVALU":"YEARS","ADTM":"2019-08-29 18:20:19","ADY":81,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-06-10 18:20:19","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-06-09 18:20:19","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-11-id-365","SUBJID":"id-365","SITEID":"USA-11","AGE":34,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-11","INVNAM":"Dr. USA-11 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":1.90915,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-06-09","TRTSDTM":"2019-06-09 18:20:19","TRTEDTM":"2021-06-09 05:58:43","EOSSTT":"COMPLETED","EOSDT":"2021-06-09","EOSDY":731,"LSTALVDT":"2021-06-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2019-06-09 18:20:19","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2023-02-18 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07344,"AVALU":"YEARS","ADTM":"2021-03-16 14:42:27","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.31905,"AVALU":"YEARS","ADTM":"2021-06-14 14:42:27","ADY":117,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.16338,"AVALU":"YEARS","ADTM":"2021-04-18 14:42:27","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":17.71429,"AVALU":"WEEKS","ADTM":"2021-06-20 20:17:22","ADY":124,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-131","SUBJID":"id-131","SITEID":"USA-12","AGE":44,"SEX":"F","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.72694,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2021-02-14","TRTSDTM":"2021-02-17 14:42:27","TRTEDTM":"2023-02-18 02:20:51","EOSSTT":"COMPLETED","EOSDT":"2023-02-18","EOSDY":731,"LSTALVDT":"2023-03-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":40.57143,"AVALU":"WEEKS","ADTM":"2021-11-27 09:25:59","ADY":284,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-06 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-07 21:16:55","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.02025,"AVALU":"YEARS","ADTM":"2020-07-13 21:16:55","ADY":8,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.24514,"AVALU":"YEARS","ADTM":"2020-10-03 21:16:55","ADY":90,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":103.42857,"AVALU":"WEEKS","ADTM":"2022-06-28 01:13:21","ADY":724,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-140","SUBJID":"id-140","SITEID":"USA-12","AGE":32,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":14.22993,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-03","TRTSDTM":"2020-07-05 21:16:55","TRTEDTM":"2022-07-06 08:55:19","EOSSTT":"COMPLETED","EOSDT":"2022-07-06","EOSDY":731,"LSTALVDT":"2022-07-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.85714,"AVALU":"WEEKS","ADTM":"2021-01-08 23:20:42","ADY":188,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-17 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-08-18 08:19:38","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.47884,"AVALU":"YEARS","ADTM":"2021-02-08 08:19:38","ADY":175,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.27942,"AVALU":"YEARS","ADTM":"2020-11-28 08:19:38","ADY":103,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":30,"AVALU":"WEEKS","ADTM":"2021-03-14 11:29:59","ADY":210,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-152","SUBJID":"id-152","SITEID":"USA-12","AGE":29,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":6.7299,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-08-14","TRTSDTM":"2020-08-17 08:19:38","TRTEDTM":"2022-08-17 19:58:02","EOSSTT":"COMPLETED","EOSDT":"2022-08-17","EOSDY":731,"LSTALVDT":"2022-09-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":71.28571,"AVALU":"WEEKS","ADTM":"2021-12-28 17:52:06","ADY":499,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-28 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-29 18:11:54","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.16409,"AVALU":"YEARS","ADTM":"2020-03-29 18:11:54","ADY":60,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.22231,"AVALU":"YEARS","ADTM":"2020-04-20 18:11:54","ADY":82,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-01-29 18:11:54","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-226","SUBJID":"id-226","SITEID":"USA-12","AGE":30,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":4.21439,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-29 18:11:54","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":63.14286,"AVALU":"WEEKS","ADTM":"2021-04-14 05:41:00","ADY":442,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.92813,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":339,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.05471,"AVALU":"YEARS","ADTM":"2020-04-07 17:01:49","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.92813,"AVALU":"YEARS","ADTM":"2021-02-20 17:01:49","ADY":339,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.57063,"AVALU":"YEARS","ADTM":"2020-10-13 17:01:49","ADY":209,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":18,"AVALU":"WEEKS","ADTM":"2020-07-21 03:32:30","ADY":126,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-343","SUBJID":"id-343","SITEID":"USA-12","AGE":38,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.75539,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-03-15","TRTSDTM":"2020-03-18 17:01:49","TRTEDTM":"2021-02-19 20:35:32","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":339,"DCSREAS":"PROTOCOL VIOLATION","LSTALVDT":"2021-03-06","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":59.71429,"AVALU":"WEEKS","ADTM":"2021-05-09 13:21:21","ADY":418,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-27 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.45517,"AVALU":"YEARS","ADTM":"2019-10-12 00:33:08","ADY":167,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-04-28 00:33:08","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.40583,"AVALU":"YEARS","ADTM":"2019-09-24 00:33:08","ADY":149,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":45,"AVALU":"WEEKS","ADTM":"2020-03-07 15:44:32","ADY":315,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-12-id-44","SUBJID":"id-44","SITEID":"USA-12","AGE":34,"SEX":"F","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-12","INVNAM":"Dr. USA-12 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":8.53653,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-04-28","TRTSDTM":"2019-04-28 00:33:08","TRTEDTM":"2021-04-27 12:11:32","EOSSTT":"COMPLETED","EOSDT":"2021-04-27","EOSDY":731,"LSTALVDT":"2021-05-19","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":102,"AVALU":"WEEKS","ADTM":"2021-04-10 01:40:14","ADY":714,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.05407,"AVALU":"YEARS","ADTM":"2021-02-12 00:00:00","ADY":385,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.05407,"AVALU":"YEARS","ADTM":"2021-02-13 11:31:30","ADY":385,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.21587,"AVALU":"YEARS","ADTM":"2020-04-13 11:31:30","ADY":79,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":1.05407,"AVALU":"YEARS","ADTM":"2021-02-13 11:31:30","ADY":385,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":2,"AVALU":"WEEKS","ADTM":"2020-02-07 19:50:39","ADY":14,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-14-id-196","SUBJID":"id-196","SITEID":"USA-14","AGE":31,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-14","INVNAM":"Dr. USA-14 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":3.92637,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-01-22","TRTSDTM":"2020-01-25 11:31:30","TRTEDTM":"2021-02-12 02:32:19","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-12","EOSDY":384,"DCSREAS":"DEATH","DTHDT":"2021-03-30","DTHCAUS":"UNKNOWN","DTHCAT":"OTHER","LDDTHELD":46,"LDDTHGR1":">30","LSTALVDT":"2021-03-30","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":51.71429,"AVALU":"WEEKS","ADTM":"2021-01-20 20:38:09","ADY":362,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-05-11 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.09772,"AVALU":"YEARS","ADTM":"2019-06-17 00:30:23","ADY":36,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.376,"AVALU":"YEARS","ADTM":"2019-09-27 00:30:23","ADY":138,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.26362,"AVALU":"YEARS","ADTM":"2019-08-17 00:30:23","ADY":97,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":22.14286,"AVALU":"WEEKS","ADTM":"2019-10-13 17:54:23","ADY":155,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-127","SUBJID":"id-127","SITEID":"USA-15","AGE":57,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.37225,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-05-09","TRTSDTM":"2019-05-12 00:30:23","TRTEDTM":"2021-05-11 12:08:47","EOSSTT":"COMPLETED","EOSDT":"2021-05-11","EOSDY":731,"LSTALVDT":"2021-05-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":3.71429,"AVALU":"WEEKS","ADTM":"2019-06-06 11:16:58","ADY":26,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-21 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-01-22 12:15:31","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.15841,"AVALU":"YEARS","ADTM":"2020-03-20 12:15:31","ADY":58,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.61454,"AVALU":"YEARS","ADTM":"2020-09-03 12:15:31","ADY":225,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3,"AVALU":"WEEKS","ADTM":"2020-02-11 08:54:14","ADY":21,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-15-id-372","SUBJID":"id-372","SITEID":"USA-15","AGE":27,"SEX":"M","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-15","INVNAM":"Dr. USA-15 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":3.4481,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-20","TRTSDTM":"2020-01-22 12:15:31","EOSSTT":"ONGOING","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":97.57143,"AVALU":"WEEKS","ADTM":"2021-12-04 00:43:54","ADY":683,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-14 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-15 12:53:42","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2021-05-15 12:53:42","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.05411,"AVALU":"YEARS","ADTM":"2019-06-03 12:53:42","ADY":20,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":12.57143,"AVALU":"WEEKS","ADTM":"2019-08-09 00:01:21","ADY":88,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-142","SUBJID":"id-142","SITEID":"USA-17","AGE":31,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":8.8187,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2019-05-13","TRTSDTM":"2019-05-14 12:53:42","TRTEDTM":"2021-05-14 00:32:06","EOSSTT":"COMPLETED","EOSDT":"2021-05-14","EOSDY":731,"LSTALVDT":"2021-06-12","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":79.42857,"AVALU":"WEEKS","ADTM":"2020-11-19 04:33:54","ADY":556,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.06776,"AVALU":"YEARS","ADTM":"2021-02-18 00:00:00","ADY":390,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":1.06776,"AVALU":"YEARS","ADTM":"2021-02-19 15:20:56","ADY":390,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.65324,"AVALU":"YEARS","ADTM":"2020-09-21 15:20:56","ADY":239,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.10921,"AVALU":"YEARS","ADTM":"2020-03-06 15:20:56","ADY":40,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":91.14286,"AVALU":"WEEKS","ADTM":"2021-10-24 14:16:53","ADY":638,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-17-id-3","SUBJID":"id-3","SITEID":"USA-17","AGE":36,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-17","INVNAM":"Dr. USA-17 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":5.39748,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-01-25","TRTSDTM":"2020-01-26 15:20:56","TRTEDTM":"2021-02-18 12:11:46","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-18","EOSDY":389,"DCSREAS":"DEATH","DTHDT":"2021-04-01","DTHCAUS":"ADVERSE EVENT","DTHCAT":"ADVERSE EVENT","LDDTHELD":42,"LDDTHGR1":">30","LSTALVDT":"2021-04-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":67.42857,"AVALU":"WEEKS","ADTM":"2021-05-11 19:08:45","ADY":472,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-01 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-11-02 20:08:15","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.07287,"AVALU":"YEARS","ADTM":"2020-11-27 20:08:15","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.08385,"AVALU":"YEARS","ADTM":"2020-12-01 20:08:15","ADY":31,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":72.85714,"AVALU":"WEEKS","ADTM":"2022-03-24 18:01:20","ADY":510,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-19-id-58","SUBJID":"id-58","SITEID":"USA-19","AGE":47,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-19","INVNAM":"Dr. USA-19 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":2.54605,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2020-10-29","TRTSDTM":"2020-10-31 20:08:15","TRTEDTM":"2022-11-01 07:46:39","EOSSTT":"COMPLETED","EOSDT":"2022-11-01","EOSDY":731,"LSTALVDT":"2022-11-29","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":50.28571,"AVALU":"WEEKS","ADTM":"2021-10-17 18:48:10","ADY":352,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":0.56674,"AVALU":"YEARS","ADTM":"2021-02-14 00:00:00","ADY":207,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":10} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.06938,"AVALU":"YEARS","ADTM":"2020-08-18 14:10:53","ADY":26,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.23803,"AVALU":"YEARS","ADTM":"2020-10-18 14:10:53","ADY":87,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.13003,"AVALU":"YEARS","ADTM":"2020-09-09 14:10:53","ADY":48,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":99.28571,"AVALU":"WEEKS","ADTM":"2022-06-17 05:59:54","ADY":695,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-2-id-110","SUBJID":"id-110","SITEID":"USA-2","AGE":35,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-2","INVNAM":"Dr. USA-2 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"A","STRATA2":"S2","BMRKR1":9.67482,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-23","TRTSDTM":"2020-07-23 14:10:53","TRTEDTM":"2021-02-14 00:23:11","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-14","EOSDY":206,"DCSREAS":"DEATH","DTHDT":"2021-02-25","DTHCAUS":"MISSING","DTHCAT":"OTHER","LDDTHELD":11,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-25","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":26.42857,"AVALU":"WEEKS","ADTM":"2021-01-23 12:01:16","ADY":185,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-20 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-07-21 03:42:15","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.59792,"AVALU":"YEARS","ADTM":"2021-02-24 03:42:15","ADY":219,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.47535,"AVALU":"YEARS","ADTM":"2021-01-10 03:42:15","ADY":174,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":2.28571,"AVALU":"WEEKS","ADTM":"2020-08-04 07:59:49","ADY":16,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-282","SUBJID":"id-282","SITEID":"USA-3","AGE":38,"SEX":"M","RACE":"AMERICAN INDIAN OR ALASKA NATIVE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":3.35944,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"Y","RANDDT":"2020-07-19","TRTSDTM":"2020-07-20 03:42:15","TRTEDTM":"2022-07-20 15:20:39","EOSSTT":"COMPLETED","EOSDT":"2022-07-20","EOSDY":731,"LSTALVDT":"2022-08-11","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":36.28571,"AVALU":"WEEKS","ADTM":"2021-03-30 22:57:49","ADY":254,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-28 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-29 11:39:41","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.15228,"AVALU":"YEARS","ADTM":"2019-09-23 11:39:41","ADY":56,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-29 11:39:41","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":99.42857,"AVALU":"WEEKS","ADTM":"2021-06-23 06:41:47","ADY":696,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-3-id-320","SUBJID":"id-320","SITEID":"USA-3","AGE":42,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-3","INVNAM":"Dr. USA-3 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":4.73445,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-07-26","TRTSDTM":"2019-07-29 11:39:41","TRTEDTM":"2021-07-28 23:18:05","EOSSTT":"COMPLETED","EOSDT":"2021-07-28","EOSDY":731,"LSTALVDT":"2021-08-08","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":15.71429,"AVALU":"WEEKS","ADTM":"2019-11-15 00:39:37","ADY":110,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":1.31417,"AVALU":"YEARS","ADTM":"2021-02-19 00:00:00","ADY":480,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":5} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.08513,"AVALU":"YEARS","ADTM":"2019-11-30 14:46:44","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.1179,"AVALU":"YEARS","ADTM":"2019-12-12 14:46:44","ADY":44,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.4872,"AVALU":"YEARS","ADTM":"2020-04-24 14:46:44","ADY":178,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":3.57143,"AVALU":"WEEKS","ADTM":"2019-11-22 22:22:10","ADY":25,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-190","SUBJID":"id-190","SITEID":"USA-4","AGE":53,"SEX":"M","RACE":"MULTIPLE","COUNTRY":"USA","DTHFL":"Y","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"B","STRATA2":"S2","BMRKR1":1.14956,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-10-29","TRTSDTM":"2019-10-29 14:46:44","TRTEDTM":"2021-02-19 04:04:20","EOSSTT":"DISCONTINUED","EOSDT":"2021-02-19","EOSDY":479,"DCSREAS":"DEATH","DTHDT":"2021-02-20","DTHCAUS":"SUICIDE","DTHCAT":"OTHER","LDDTHELD":1,"LDDTHGR1":"<=30","LSTALVDT":"2021-02-20","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":96,"AVALU":"WEEKS","ADTM":"2021-08-30 23:26:47","ADY":672,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-02 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":6} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-09-03 10:42:05","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.32763,"AVALU":"YEARS","ADTM":"2020-01-01 10:42:05","ADY":120,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.07982,"AVALU":"YEARS","ADTM":"2019-10-03 10:42:05","ADY":30,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":80.57143,"AVALU":"WEEKS","ADTM":"2021-03-19 15:15:53","ADY":564,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-4-id-382","SUBJID":"id-382","SITEID":"USA-4","AGE":31,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-4","INVNAM":"Dr. USA-4 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":7.94871,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2019-09-01","TRTSDTM":"2019-09-03 10:42:05","TRTEDTM":"2021-09-02 22:20:29","EOSSTT":"COMPLETED","EOSDT":"2021-09-02","EOSDY":731,"LSTALVDT":"2021-09-18","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":86.14286,"AVALU":"WEEKS","ADTM":"2021-04-27 20:52:33","ADY":603,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-08 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2022-09-09 01:59:18","ADY":731,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"End of AE Reporting Period"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.46916,"AVALU":"YEARS","ADTM":"2021-02-27 01:59:18","ADY":172,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.15389,"AVALU":"YEARS","ADTM":"2020-11-04 01:59:18","ADY":57,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42.42857,"AVALU":"WEEKS","ADTM":"2021-07-01 15:21:58","ADY":297,"CNSR":0,"EVNTDESC":"First Post-Baseline Raised ALT or AST Elevation Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-5-id-179","SUBJID":"id-179","SITEID":"USA-5","AGE":30,"SEX":"M","RACE":"BLACK OR AFRICAN AMERICAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-5","INVNAM":"Dr. USA-5 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S1","BMRKR1":4.67743,"BMRKR2":"LOW","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-09-07","TRTSDTM":"2020-09-08 01:59:18","TRTEDTM":"2022-09-08 13:37:42","EOSSTT":"COMPLETED","EOSDT":"2022-09-08","EOSDY":731,"LSTALVDT":"2022-09-28","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":0.14286,"AVALU":"WEEKS","ADTM":"2020-09-08 01:59:18","ADY":1,"CNSR":1,"CNSDTDSC":"Treatment Start"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-12 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":0} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.00151,"AVALU":"YEARS","ADTM":"2020-04-12 20:53:10","ADY":1,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-04-13 20:53:10","ADY":732,"CNSR":1,"EVNTDESC":"","CNSDTDSC":"Clinical Cut Off"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.11099,"AVALU":"YEARS","ADTM":"2020-05-22 20:53:10","ADY":41,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":88.14286,"AVALU":"WEEKS","ADTM":"2021-12-18 15:29:20","ADY":617,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-6-id-151","SUBJID":"id-151","SITEID":"USA-6","AGE":30,"SEX":"F","RACE":"WHITE","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-6","INVNAM":"Dr. USA-6 Doe","ARM":"B: Placebo","ARMCD":"ARM B","ACTARM":"B: Placebo","ACTARMCD":"ARM B","REGION1":"North America","STRATA1":"C","STRATA2":"S2","BMRKR1":2.04531,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"N","RANDDT":"2020-04-07","TRTSDTM":"2020-04-11 20:53:10","TRTEDTM":"2022-04-12 08:31:34","EOSSTT":"COMPLETED","EOSDT":"2022-04-12","EOSDY":731,"LSTALVDT":"2022-04-22","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":7.85714,"AVALU":"WEEKS","ADTM":"2020-06-04 15:52:48","ADY":55,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00137,"AVALU":"YEARS","ADTM":"2021-07-21 00:00:00","ADY":731,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":3} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":7} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":8} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.07183,"AVALU":"YEARS","ADTM":"2019-08-18 10:19:01","ADY":27,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.08493,"AVALU":"YEARS","ADTM":"2019-08-23 10:19:01","ADY":32,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.0097,"AVALU":"YEARS","ADTM":"2019-07-26 10:19:01","ADY":4,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":42.71429,"AVALU":"WEEKS","ADTM":"2020-05-15 12:46:56","ADY":299,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-8-id-206","SUBJID":"id-206","SITEID":"USA-8","AGE":34,"SEX":"F","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-8","INVNAM":"Dr. USA-8 Doe","ARM":"C: Combination","ARMCD":"ARM C","ACTARM":"C: Combination","ACTARMCD":"ARM C","REGION1":"North America","STRATA1":"B","STRATA2":"S1","BMRKR1":14.47806,"BMRKR2":"HIGH","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"Y","BEP01FL":"Y","RANDDT":"2019-07-19","TRTSDTM":"2019-07-22 10:19:01","TRTEDTM":"2021-07-21 21:57:25","EOSSTT":"COMPLETED","EOSDT":"2021-07-21","EOSDY":731,"LSTALVDT":"2021-08-01","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":103.14286,"AVALU":"WEEKS","ADTM":"2021-07-12 15:54:48","ADY":722,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":6,"TTESEQ":6,"PARAM":"Time to end of AE reporting period","PARAMCD":"AEREPTTE","AVAL":2.00411,"AVALU":"YEARS","ADTM":"2022-07-19 00:00:00","ADY":732,"CNSR":0,"EVNTDESC":"Completion or Discontinuation"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":7,"TTESEQ":7,"PARAM":"Number of occurrences of any adverse event","PARAMCD":"AETOT1","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":8,"TTESEQ":8,"PARAM":"Number of occurrences of any serious adverse event","PARAMCD":"AETOT2","AVAL":2} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":9,"TTESEQ":9,"PARAM":"Number of occurrences of a grade 3-5 adverse event","PARAMCD":"AETOT3","AVAL":4} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":1,"TTESEQ":1,"PARAM":"Time to first occurrence of any adverse event","PARAMCD":"AETTE1","AVAL":0.21206,"AVALU":"YEARS","ADTM":"2020-10-04 19:28:19","ADY":78,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":3,"TTESEQ":3,"PARAM":"Time to first occurrence of any serious adverse event","PARAMCD":"AETTE2","AVAL":0.96065,"AVALU":"YEARS","ADTM":"2021-07-04 19:28:19","ADY":351,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":2,"TTESEQ":2,"PARAM":"Time to first occurrence of a grade 3-5 adverse event","PARAMCD":"AETTE3","AVAL":0.46738,"AVALU":"YEARS","ADTM":"2021-01-05 19:28:19","ADY":171,"CNSR":0,"EVNTDESC":"Preferred Term","CNSDTDSC":""} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":5,"TTESEQ":5,"PARAM":"Time to Hy's Law Elevation in relation to Baseline","PARAMCD":"HYSTTEBL","AVAL":94.42857,"AVALU":"WEEKS","ADTM":"2022-05-09 19:26:13","ADY":661,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"} {"STUDYID":"AB12345","USUBJID":"AB12345-USA-9-id-130","SUBJID":"id-130","SITEID":"USA-9","AGE":40,"SEX":"M","RACE":"ASIAN","COUNTRY":"USA","DTHFL":"N","INVID":"INV ID USA-9","INVNAM":"Dr. USA-9 Doe","ARM":"A: Drug X","ARMCD":"ARM A","ACTARM":"A: Drug X","ACTARMCD":"ARM A","REGION1":"North America","STRATA1":"A","STRATA2":"S1","BMRKR1":1.28053,"BMRKR2":"MEDIUM","ITTFL":"Y","SAFFL":"Y","BMEASIFL":"N","BEP01FL":"N","RANDDT":"2020-07-17","TRTSDTM":"2020-07-18 19:28:19","TRTEDTM":"2022-07-19 07:06:43","EOSSTT":"COMPLETED","EOSDT":"2022-07-19","EOSDY":731,"LSTALVDT":"2022-08-17","study_duration_secs":63113904,"ASEQ":4,"TTESEQ":4,"PARAM":"Time to Hy's Law Elevation in relation to ULN","PARAMCD":"HYSTTEUL","AVAL":84.71429,"AVALU":"WEEKS","ADTM":"2022-03-02 11:12:21","ADY":593,"CNSR":1,"CNSDTDSC":"Last Post-Baseline ALT or AST Result"}