| Title: | ADaM Test Data for the 'Pharmaverse' Family of Packages |
|---|---|
| Description: | A set of Analysis Data Model (ADaM) datasets constructed using the Study Data Tabulation Model (SDTM) datasets contained in the 'pharmaversesdtm' package and the template scripts from the 'admiral' family of packages. ADaM dataset specifications are described in the CDISC ADaM implementation guide, accessible by creating a free account on <https://www.cdisc.org/>. |
| Authors: | Fanny Gautier [aut, cre] (ORCID: <https://orcid.org/0009-0004-3581-0131>), Stefan Bundfuss [aut] (ORCID: <https://orcid.org/0009-0005-0027-1198>), Edoardo Mancini [aut] (ORCID: <https://orcid.org/0009-0006-4899-8641>), Lina Patil [aut], Gerardo Jose Rodriguez [aut] (ORCID: <https://orcid.org/0000-0003-1413-0060>), Vladyslav Shuliar [aut] (ORCID: <https://orcid.org/0009-0008-2354-8999>), Cytel Inc. [cph, fnd], F. Hoffmann-La Roche AG [cph, fnd], GlaxoSmithKline LLC [cph, fnd] |
| Maintainer: | Fanny Gautier <[email protected]> |
| License: | Apache License (>= 2) |
| Version: | 1.3.0 |
| Built: | 2026-05-21 08:45:47 UTC |
| Source: | https://github.com/pharmaverse/pharmaverseadam |
Anti-Drug Antibody Analysis Dataset
adabadab
A data frame with 72 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Analysis Sequence Number
Geographic Region 1
Country
Ethnicity
Age
Age Units
Sex
Race
Safety Population Flag
Description of Planned Arm
Description of Actual Arm
Datetime of First Exposure to Treatment
Date of First Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of Last Exposure to Treatment
Sequence Number
Immunogenicity Test/Exam Short Name
Immunogenicity Test or Examination Name
Category for Immunogenicity Test
Binding Agent
Character Result/Finding in Std Format
Numeric Results/Findings in Std. Units
Standard Units
Completion Status
Reason Not Done
Specimen Type
Drug Tolerance Level
Minimum Reportable Titer
Visit Number
Visit Name
Planned Study Day of Visit
Epoch
Date/Time of Collection
Study Day of Visit/Collection/Exam
Planned Time Point Name
Planned Time Point Number
Parameter
Parameter Code
Parameter Category 1
Analysis Value
Analysis Value (C)
Analysis Value Unit
Baseline Type
Baseline Value
Change from Baseline
Derivation Type
Analysis Datetime
Analysis Date
Analysis Relative Day
Analysis Time Imputation Flag
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Phase
Phase (N)
Period
Period (C)
First Datetime of Dose for Analyte
First Date of Dose for Analyte
First Time of Dose for Analyte
First Time of Dose for Analyte ImputeFL
Nom. Rel. Time from Analyte First Dose
Act. Rel. Time from Analyte First Dose
Rel. Time from First Dose Unit
Baseline Record Flag
Baseline ADA Eval. Param-Level Flag
Post-Baseline ADA Eval. Param-Level Flag
ADA Population Flag
Contains a set of 22 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| ADADUR1 | ADA Duration (Weeks), Anti-XANOMELINE Antibody (1) |
| ADASTAT1 | ADA Status of a patient, Anti-XANOMELINE Antibody (1) |
| ADASTTV1 | ADA Status of a patient by Visit, Anti-XANOMELINE Antibody (1) |
| BABXANOM | Anti-XANOMELINE Antibody, Titer Units (1) |
| BFLAG1 | Baseline Pos/Neg, Anti-XANOMELINE Antibody (1) |
| EMERNEG1 | Treatment Emergent - Negative, Anti-XANOMELINE Antibody (1) |
| EMERPOS1 | Treatment Emergent - Positive, Anti-XANOMELINE Antibody (1) |
| ENHANC1 | Treatment enhanced ADA, Anti-XANOMELINE Antibody (1) |
| FPPDTM1 | First Post Dose Positive Datetime, Anti-XANOMELINE Antibody (1) |
| INDUCD1 | Treatment induced ADA, Anti-XANOMELINE Antibody (1) |
| LPPDTM1 | Last Post Dose Positive Datetime, Anti-XANOMELINE Antibody (1) |
| NABSTAT1 | Nab Status, Anti-XANOMELINE Neutralizing Antibody (1) |
| NABXANOM | Anti-XANOMELINE Neutralizing Antibody (1) |
| NOTRREL1 | No treatment related ADA, Anti-XANOMELINE Antibody (1) |
| PBFLAGV1 | Post Baseline Pos/Neg by Visit, Anti-XANOMELINE Antibody (1) |
| PERSADA1 | Persistent ADA, Anti-XANOMELINE Antibody (1) |
| RESULT1 | ADA interpreted per sample result, Anti-XANOMELINE Antibody (1) |
| RESULT2 | Nab interpreted per sample result, Anti-XANOMELINE Neutralizing Antibody (2) |
| TFLAGV1 | Treatment related ADA by Visit, Anti-XANOMELINE Antibody (1) |
| TIMADA1 | Time to onset of ADA (Weeks), Anti-XANOMELINE Antibody (1) |
| TRANADA1 | Transient ADA, Anti-XANOMELINE Antibody (1) |
| TRUNAFF1 | Treatment unaffected, Anti-XANOMELINE Antibody (1) |
Generated from admiral package (template ad_adab.R).
None
data("adab")data("adab")
Adverse Events Analysis
adaeadae
A data frame with 107 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Sequence Number
Reported Term for the Adverse Event
Dictionary-Derived Term
Body System or Organ Class
Body System or Organ Class Code
Lowest Level Term
Lowest Level Term Code
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Primary System Organ Class
Primary System Organ Class Code
Start Date/Time of Adverse Event
Analysis Start Date
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
End Date/Time of Adverse Event
Analysis End Date
Analysis End Date/Time
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Relative Day
Study Day of Start of Adverse Event
Analysis End Relative Day
Study Day of End of Adverse Event
Analysis Duration (N)
Analysis Duration Units
Treatment Emergent Analysis Flag
1st Max Sev./Int. Occurrence Flag
Serious Event
Results in Death
Is Life Threatening
Requires or Prolongs Hospitalization
Persist or Signif Disability/Incapacity
Congenital Anomaly or Birth Defect
Severity/Intensity
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Causality
Analysis Causality
Action Taken with Study Treatment
Sponsor-Defined Identifier
Outcome of Adverse Event
Involves Cancer
Occurred with Overdose
Date/Time of Collection
End Date/Time of Last Dose
Treatment Dose
Treatment Dose Unit
Generated from admiral package (template ad_adae.R).
None
data("adae")data("adae")
Amyloid PET Scan Analysis Dataset
adapet_neuroadapet_neuro
A data frame with 49 columns:
Study Identifier
Unique Subject Identifier
Domain Abbreviation
Analysis Sequence Number
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Analysis Value
Analysis Value (C)
Analysis Value Unit
Baseline Value
Baseline Value (C)
Baseline Type
Change from Baseline
Percent Change from Baseline
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
On Treatment Record Flag
Sequence Number
Link ID
Short Name of Nervous System Test
Name of Nervous System Test
Category for Nervous System Test
Location Used for the Measurement
Vendor Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Method of Test or Examination
Last Observation Before Exposure Flag
Reference Region
Reported Agent Name
Category for Agent
Visit Number
Visit Name
Date/Time of Collection
Study Day of Visit/Collection/Exam
Contains a set of 7 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| CENTLD | Centiloid value derived from SUVR pipeline |
| SUVRAFBB | AVID FBB Standard Uptake Ratio Neocortical Composite Whole Cerebellum |
| SUVRAFBP | AVID FBP Standard Uptake Ratio Neocortical Composite Whole Cerebellum |
| SUVRBFBB | BERKELEY FBB Standard Uptake Ratio Neocortical Composite Whole Cerebellum |
| SUVRBFBP | BERKELEY FBP Standard Uptake Ratio Neocortical Composite Whole Cerebellum |
| VRFBB | FBB Qualitative Visual Classification |
| VRFBP | FBP Qualitative Visual Classification |
Generated from admiralneuro package (template ad_adapet.R).
None
data("adapet_neuro")data("adapet_neuro")
Best Corrected Visual Acuity Analysis
adbcva_ophthaadbcva_ophtha
A data frame with 71 columns:
Study Identifier
Unique Subject Identifier
Domain Abbreviation
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Parameter
Parameter Code
Analysis Value
Analysis Value (C)
Analysis Value Unit
Analysis Value Category 1
Analysis Value Category 1 (N)
Baseline Value
Baseline Value (C)
Baseline Type
Change from Baseline
Percent Change from Baseline
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Analysis Criterion 2
Criterion 2 Evaluation Result Flag
Analysis Criterion 3
Criterion 3 Evaluation Result Flag
Analysis Criterion 4
Criterion 4 Evaluation Result Flag
Analysis Criterion 5
Criterion 5 Evaluation Result Flag
Analysis Criterion 6
Criterion 6 Evaluation Result Flag
Analysis Criterion 7
Criterion 7 Evaluation Result Flag
Analysis Criterion 8
Criterion 8 Evaluation Result Flag
Derivation Type
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
On Treatment Record Flag
Sequence Number
Category for Ophthalmic Test or Exam
Subcategory for Ophthalmic Test or Exam
Date/Time of Collection
Visit Name
Visit Number
Planned Study Day of Visit
Numeric Result/Finding in Standard Units
Character Result/Finding in Std Format
Result or Finding in Original Units
Name of Ophthalmic Test or Exam
Short Name of Ophthalmic Test or Exam
Ophthalmic Test or Exam Detail
Laterality
Location Used for the Measurement
Study Day of Visit/Collection/Exam
Method of Test or Examination
Original Units
Standard Units
Completion Status
Planned Time Point Name
Planned Time Point Number
Study Eye Location
Affected Eye
Worst Post Baseline Obs
Contains a set of 4 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| FBCVA | Fellow Eye Visual Acuity Score (letters) |
| FBCVALOG | Fellow Eye Visual Acuity LogMAR Score |
| SBCVA | Study Eye Visual Acuity Score (letters) |
| SBCVALOG | Study Eye Visual Acuity LogMAR Score |
Generated from admiralophtha package (template ad_adbcva.R).
None
data("adbcva_ophtha")data("adbcva_ophtha")
Clinical Events Analysis for Vaccine
adce_vaccineadce_vaccine
A data frame with 56 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Analysis Sequence Number
Age
Age Units
Sex
Race
Ethnicity
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Period Start Date
Period End Date
Analysis Sub-period Start Relative Day
Sequence Number
Reported Term for the Clinical Event
Dictionary-Derived Term
Category for the Clinical Event
Subcategory for the Clinical Event
Start Date/Time of Clinical Event
Analysis Start Date
End Date/Time of Clinical Event
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Analysis Duration (N)
Analysis Duration Units
Duration of Clinical Event
Period
Clinical Event Occurrence
Clinical Event Pre-specified
Event Occurrence Flag
Analysis Severity/Intensity
Analysis Severity/Intensity (N)
Analysis Causality
Link ID
Link Group ID
Laterality
Location of Event
Severity/Intensity
Causality
Outcome of Event
Epoch
Date/Time of Event Collection
Planned Time Point Name
Planned Time Point Number
Time Point Reference
Date/Time of Reference Time Point
Evaluation Interval Text
Completion Status
Reason Clinical Event Not Collected
Generated from admiralvaccine package (template ad_adce.R).
None
data("adce_vaccine")data("adce_vaccine")
Concomitant Medications Analysis
adcmadcm
A data frame with 95 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Treatment End Datetime Imput Flag
Phase
Description of Phase N
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Sequence Number
Standardized Medication Name
Reported Name of Drug, Med, or Therapy
Medication Class
Start Date/Time of Medication
Analysis Start Date
Analysis Start Date/Time
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
End Date/Time of Medication
Analysis End Date
Analysis End Date/Time
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Relative Day
Study Day of Start of Medication
Analysis End Relative Day
Study Day of End of Medication
Analysis Duration (N)
Analysis Duration Units
Analysis Flag 01
On Treatment Record Flag
Pre-treatment Flag
Follow-up Flag
1st Occurrence of Preferred Term Flag
Indication
Dose per Administration
Dose Units
Dosing Frequency per Interval
Route of Administration
Sponsor-Defined Identifier
End Relative to Reference Time Point
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Collection
Generated from admiral package (template ad_adcm.R).
None
data("adcm")data("adcm")
Questionnaires Analysis for Metabolic
adcoeq_metabolicadcoeq_metabolic
A data frame with 85 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value (C)
Baseline Value
Change from Baseline
Percent Change from Baseline
Baseline Record Flag
Visit Name
Visit Number
Planned Study Day of Visit
Baseline Flag
Date/Time of Finding
Study Day of Finding
Category for Questionnaire
Questionnaire Test Name
Questionnaire Test Short Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Sequence Number
Contains a set of 25 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| COEQ01 | How hungry have you felt? |
| COEQ02 | How full have you felt? |
| COEQ03 | How strong was your desire to eat sweet foods? |
| COEQ04 | How strong was your desire to eat savoury foods? |
| COEQ05 | How happy have you felt? |
| COEQ06 | How anxious have you felt? |
| COEQ07 | How alert have you felt? |
| COEQ08 | How contented have you felt? |
| COEQ09 | During the last 7 days how often have you had food cravings? |
| COEQ10 | How strong have any food cravings been? |
| COEQ11 | How difficult has it been to resist any food cravings? |
| COEQ12 | How often have you eaten in response to food cravings? |
| COEQ13 | Chocolate or chocolate flavoured foods |
| COEQ14 | Other sweet foods (cakes, pastries, biscuits, etc) |
| COEQ15 | Fruit or fruit juice |
| COEQ16 | Dairy foods (cheese, yoghurts, milk, etc) |
| COEQ17 | Starchy foods (bread, rice, pasta, etc) |
| COEQ18 | Savoury foods (french fries, crisps, burgers, pizza, etc) |
| COEQ19 | Generally, how difficult has it been to control your eating? |
| COEQ20 | Which one food makes it most difficult for you to control eating? |
| COEQ21 | How difficult has it been to resist eating this food during the last 7 days? |
| COEQCRCO | COEQ - Craving Control |
| COEQCRSA | COEQ - Craving for Savoury |
| COEQCRSW | COEQ - Craving for Sweet |
| COEQPOMO | COEQ - Positive Mood |
Generated from admiralmetabolic package (template ad_adcoeq.R).
None
data("adcoeq_metabolic")data("adcoeq_metabolic")
Electrocardiogram Tests Analysis
adegadeg
A data frame with 108 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Datetime
Analysis Relative Day
Analysis Time Imputation Flag
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Parameter
Parameter Code
Parameter (N)
Analysis Value
Analysis Value (C)
Analysis Value Category 1
Analysis Value Category 1 (N)
Baseline Value
Baseline Value (C)
Baseline Type
Change from Baseline
Change from Baseline Category 1
Change from Baseline Category 1 (N)
Percent Change from Baseline
Derivation Type
Analysis Reference Range Indicator
Baseline Reference Range Indicator
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Baseline Record Flag
Analysis Flag 01
On Treatment Record Flag
Sequence Number
ECG Test or Examination Short Name
ECG Test or Examination Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Lead Location Used for Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of ECG
Study Day of ECG
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Contains a set of 8 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| EGINTP | ECG Interpretation |
| HR | Heart Rate (beats/min) |
| QT | QT Duration (ms) |
| QTCBR | QTcB - Bazett's Correction Formula Rederived (ms) |
| QTCFR | QTcF - Fridericia's Correction Formula Rederived (ms) |
| QTLCR | QTlc - Sagie's Correction Formula Rederived (ms) |
| RR | RR Duration (ms) |
| RRR | RR Duration Rederived (ms) |
Generated from admiral package (template ad_adeg.R).
None
data("adeg")data("adeg")
Exposure Analysis
adexadex
A data frame with 92 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Name of Treatment
Dose
Dose Form
Dosing Frequency per Interval
Route of Administration
Reason for Dose Adjustment
Start Date/Time of Treatment
End Date/Time of Treatment
Study Day of Start of Treatment
Study Day of End of Treatment
Sequence Number
Analysis Start Date
Analysis End Date
Duration of Treatment (Days)
Dose Units
Visit Number
Visit Name
Planned Study Day of Visit
Planned Dose
Analysis Start Datetime
Analysis Start Date Imputation Flag
Analysis Start Time Imputation Flag
Analysis End Datetime
Analysis End Date Imputation Flag
Analysis End Time Imputation Flag
Analysis Start Relative Day
Analysis End Relative Day
Dose O
PDose O
Parameter Code
Analysis Value
Analysis Value (C)
Parameter Category 1
Parameter
Parameter (N)
Analysis Value Category 1
Contains a set of 19 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| ADJ | Dose adjusted during constant dosing interval |
| ADJAE | Dose adjusted due to AE during constant dosing interval |
| AVDDSE | Average daily dose administered (mg/mg) |
| DOSE | Dose administered during constant dosing interval (mg) |
| DURD | Study drug duration during constant dosing interval (days) |
| PADJ | Dose adjusted during W2-W24 |
| PADJAE | Dose adjusted in W2-W24 due to AE |
| PAVDDSE | Average daily dose administered in W2-W24 (mg) |
| PDOSE | Total dose administered in W2-W2 (mg)4 |
| PDOSINT | W2-24 dose intensity (%) |
| PDURD | Overall duration in W2-W24 (days) |
| PLDOSE | Planned dose during constant dosing interval (mg) |
| PPDOSE | Total planned dose in W2-W24 (mg) |
| TADJ | Dose adjusted during study |
| TADJAE | Dose adjusted during study due to AE |
| TDOSE | Total dose administered (mg) |
| TDOSINT | Overall dose intensity (%) |
| TDURD | Overall duration (days) |
| TPDOSE | Total planned dose (mg) |
Generated from admiral package (template ad_adex.R).
None
data("adex")data("adex")
Findings About Clinical Events Analysis
adface_vaccineadface_vaccine
A data frame with 61 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Age
Age Units
Sex
Race
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 02
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Period Start Date
Period End Date
Analysis Date
Analysis Datetime
Analysis Relative Day
Analysis Timepoint
Analysis Timepoint (N)
Analysis Timepoint Reference
Period
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Parameter Category 2
Analysis Value
Analysis Value (C)
Analysis Flag 01
Analysis Flag 02
Analysis Flag 03
Findings About Test Name
Link ID
Link Group ID
Findings About Test Short Name
Object of the Observation
Completion Status
Reason Not Performed
Evaluator
Epoch
Evaluation Interval Text
Dose
Name of Treatment
Start Date/Time of Treatment
End Date/Time of Treatment
Result or Finding in Original Units
Vaccination Date 01
Vaccination Date 02
Event Value Flag
Day Event Value Flag
Contains a set of 30 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| DIARE | Redness diameter deltoid muscle left |
| DIASWEL | Swelling diameter deltoid muscle left |
| MAXREDN | Redness maximum severity deltoid muscle left |
| MAXSFAT | Fatigue maximum severity |
| MAXSHEA | Headache maximum severity |
| MAXSPIS | Pain at injection site maximum severity deltoid muscle left |
| MAXSWEL | Swelling maximum severity deltoid muscle left |
| MAXTEMP | Fever maximum temperature |
| MDIRE | Redness maximum diameter deltoid muscle left |
| MDISW | Swelling maximum diameter deltoid muscle left |
| MSEVNWJP | New or worsened joint pain maximum severity |
| MSEVNWMP | New or worsened muscle pain maximum severity |
| OCCHILLS | Chills occurrence indicator |
| OCCNWJP | New or worsened joint pain occurrence indicator |
| OCCNWMP | New or worsened muscle pain occurrence indicator |
| OCCVOM | Vomiting occurrence indicator |
| OCDIAR | Diarrhea occurrence indicator |
| OCFATIG | Fatigue occurrence indicator |
| OCFEVER | Fever occurrence indicator |
| OCHEAD | Headache occurrence indicator |
| OCINS | Swelling occurrence indicator deltoid muscle left |
| OCISR | Redness occurrence indicator deltoid muscle left |
| OCPIS | Pain at injection site occurrence indicator deltoid muscle left |
| SEVFAT | Fatigue severity/intensity |
| SEVHEAD | Headache severity/intensity |
| SEVNWJP | New or worsened joint pain severity/intensity |
| SEVNWMP | New or worsened muscle pain severity/intensity |
| SEVPIS | Pain at injection site severity/intensity deltoid muscle left |
| SEVREDN | Redness severity/intensity deltoid muscle left |
| SEVSWEL | Swelling severity/intensity deltoid muscle left |
Generated from admiralvaccine package (template ad_adface.R).
None
data("adface_vaccine")data("adface_vaccine")
Immunogenicity Specimen Assessments
adis_vaccineadis_vaccine
A data frame with 103 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Geographic Region 1
Date/Time of Birth
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Per-Protocol Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 02
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Period 01 Start Date
Period 01 End Date
Period 02 Start Date
Period 02 End Date
Period Start Date
Period End Date
Date/Time of Informed Consent
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Analysis Timepoint Reference
Period
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value Unit
Baseline Value
Baseline Category 1
Baseline Type
Change from Baseline
Ratio to Baseline
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Criterion 1 Evaluation Result Flag (N)
Derivation Type
Baseline Record Flag
Sequence Number
Immunogenicity Test/Exam Short Name
Immunogenicity Test or Examination Name
Category for Immunogenicity Test
Results or Findings in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Results/Findings in Std. Units
Standard Units
Completion Status
Reason Not Done
Vendor Name
Specimen Type
Method of Test or Examination
Baseline Flag
Lower Limit of Quantitation
Visit Number
Epoch
Date/Time of Collection
Study Day of Visit/Collection/Exam
Upper Limit of Quantitation
Limit of Detection
Derivation Method
First Cutoff Value
Second Cutoff Value
Pre-vaccination seropositivity status
Pre-vaccination sero status (n)
Per-Protocol Record-Level Flag
Investigator Identifier
Investigator Name
Vaccination Date 01
Vaccination Date 02
Contains a set of 16 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| I0019NLF | LOG10 4FOLD (I0019NT Antibody) |
| I0019NT | I0019NT Antibody |
| I0019NTF | 4FOLD (I0019NT Antibody) |
| I0019NTL | LOG10 (I0019NT Antibody) |
| J0033VLF | LOG10 4FOLD (J0033VN Antibody) |
| J0033VN | J0033VN Antibody |
| J0033VNF | 4FOLD (J0033VN Antibody) |
| J0033VNL | LOG10 (J0033VN Antibody) |
| M0019LLF | LOG10 4FOLD (M0019LN Antibody) |
| M0019LN | M0019LN Antibody |
| M0019LNF | 4FOLD (M0019LN Antibody) |
| M0019LNL | LOG10 (M0019LN Antibody) |
| R0003MA | R0003MA Antibody |
| R0003MAF | 4FOLD (R0003MA Antibody) |
| R0003MAL | LOG10 (R0003MA Antibody) |
| R0003MLF | LOG10 4FOLD (R0003MA Antibody) |
Generated from admiralvaccine package (template ad_adis.R).
None
data("adis_vaccine")data("adis_vaccine")
Laboratory Analysis
adlbadlb
A data frame with 115 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value (C)
Baseline Value
Baseline Value (C)
Baseline Type
Change from Baseline
Percent Change from Baseline
Ratio to Baseline
Ratio of Analysis Val compared to ANRLO
Ratio of Analysis Val compared to ANRHI
Shift from Baseline to Analysis Value
Shift from Baseline to Overall Grade
Derivation Type
Analysis Toxicity Grade
Baseline Toxicity Grade
Analysis Reference Range Indicator
Baseline Reference Range Indicator
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Analysis Toxicity Grade Low
Analysis Toxicity Grade High
Baseline Toxicity Grade Low
Baseline Toxicity Grade High
Analysis Toxicity Description Low
Analysis Toxicity Description High
Baseline Record Flag
Analysis Flag 01
On Treatment Record Flag
Last Value On Treatment Record Flag
Sequence Number
Lab Test or Examination Short Name
Lab Test or Examination Name
Category for Lab Test
Result or Finding in Original Units
Original Units
Reference Range Lower Limit in Orig Unit
Reference Range Upper Limit in Orig Unit
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Reference Range Lower Limit-Std Units
Reference Range Upper Limit-Std Units
Reference Range Indicator
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Specimen Collection
Study Day of Specimen Collection
Contains a set of 47 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| ALB | Albumin (g/L) |
| ALKPH | Alkaline Phosphatase (U/L) |
| ALT | Alanine Aminotransferase (U/L) |
| ANISO | Anisocytes |
| AST | Aspartate Aminotransferase (U/L) |
| BASO | Basophils Abs (10^9/L) |
| BASOLE | Basophils/Leukocytes (FRACTION) |
| BILI | Bilirubin (umol/L) |
| BUN | Blood Urea Nitrogen (mmol/L) |
| CA | Calcium (mmol/L) |
| CHOLES | Cholesterol (mmol/L) |
| CK | Creatinine Kinase (U/L) |
| CL | Chloride (mmol/L) |
| COLOR | Color |
| CREAT | Creatinine (umol/L) |
| EOS | Eosinophils (10^9/L) |
| EOSLE | Eosinophils/Leukocytes (FRACTION) |
| GGT | Gamma Glutamyl Transferase (U/L) |
| GLUC | Glucose (mmol/L) |
| HBA1C | Hemoglobin A1C (1) |
| HCT | Hematocrit (1) |
| HGB | Hemoglobin (mmol/L) |
| KETON | Ketones |
| LYMPH | Lymphocytes Abs (10^9/L) |
| LYMPHLE | Lymphocytes/Leukocytes (FRACTION) |
| MACROC | Macrocytes |
| MCH | Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) |
| MCHC | Ery. Mean Corpuscular HGB Concentration (mmol/L) |
| MCV | Ery. Mean Corpuscular Volume (f/L) |
| MICROC | Microcytes |
| MONO | Monocytes (10^9/L) |
| MONOLE | Monocytes/Leukocytes (FRACTION) |
| PH | pH |
| PHOS | Phosphate (mmol/L) |
| PLAT | Platelet (10^9/L) |
| POIKIL | Poikilocytes |
| POLYCH | Polychromasia |
| POTAS | Potassium (mmol/L) |
| PROT | Protein (g/L) |
| RBC | Erythrocytes (TI/L) |
| SODIUM | Sodium (mmol/L) |
| SPGRAV | Specific Gravity |
| TSH | Thyrotropin (mU/L) |
| URATE | Urate (umol/L) |
| UROBIL | Urobilinogen |
| VITB12 | Vitamin B12 (pmol/L) |
| WBC | Leukocytes (10^9/L) |
Generated from admiral package (template ad_adlb.R).
None
data("adlb")data("adlb")
Laboratory Analysis for Metabolic
adlb_metabolicadlb_metabolic
A data frame with 43 columns:
Study Identifier
Unique Subject Identifier
Domain Abbreviation
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Parameter Category 2
Analysis Value
Analysis Value (C)
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Sequence Number
Lab Test or Examination Short Name
Lab Test or Examination Name
Category for Lab Test
Result or Finding in Original Units
Original Units
Reference Range Lower Limit in Orig Unit
Reference Range Upper Limit in Orig Unit
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Reference Range Lower Limit-Std Units
Reference Range Upper Limit-Std Units
Reference Range Indicator
Baseline Flag
Fasting Status
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Specimen Collection
Study Day of Specimen Collection
Body Mass Index (kg/m2)
Waist Circumference (cm)
Contains a set of 11 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| ALB | Albumin (g/L) |
| ALKPH | Alkaline Phosphatase (U/L) |
| AST | Aspartate Aminotransferase (U/L) |
| CHOLES | Cholesterol (mmol/L) |
| FLI | Fatty Liver Index |
| GGT | Gamma Glutamyl Transferase (U/L) |
| GLUC | Glucose (mmol/L) |
| HBA1CHGB | Hemoglobin A1C/Hemoglobin (mmol/mol) |
| HOMAIR | Homeostasis Model Assessment - Insulin Resistance |
| INSULIN | Insulin (mIU/L) |
| TRIG | Triglycerides (mg/dL) |
Generated from admiralmetabolic package (template ad_adlb.R).
None
data("adlb_metabolic")data("adlb_metabolic")
Analysis of Lab Hy's Law
adlbhyadlbhy
A data frame with 14 columns:
Study Identifier
Unique Subject Identifier
Actual Treatment for Period 01
Analysis Date
Analysis Relative Day
Analysis Visit
Parameter
Parameter Code
Analysis Value
Analysis Value (C)
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Analysis Normal Range Upper Limit
Sequence Number
Contains a set of 4 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| ALT | Alanine Aminotransferase (U/L) |
| AST | Aspartate Aminotransferase (U/L) |
| BILI | Bilirubin (umol/L) |
| HYSLAW | ALT/AST >= 3xULN and BILI >= 2xULN |
Generated from admiral package (template ad_adlbhy.R).
None
data("adlbhy")data("adlbhy")
Medical History Analysis
admhadmh
A data frame with 114 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Treatment End Datetime Imput Flag
Phase
Description of Phase N
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Sequence Number
Reported Term for the Medical History
Medical History Term (N)
Dictionary-Derived Term
Body System or Organ Class
Lowest Level Term
High Level Term
High Level Group Term
Category for Medical History
Start Date/Time of Medical History Event
Analysis Start Date
End Date/Time of Medical History Event
Analysis End Date
Analysis Start Relative Day
Analysis End Relative Day
Medical History Occurrence
Medical History Event Pre-Specified
Analysis Flag 01
1st Occurrence within Subject Flag
1st Occurrence of Preferred Term Flag
1st Occurrence of SOC Flag
Sponsor-Defined Identifier
Severity/Intensity
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of History Collection
Study Day of History Collection
Start Relative to Reference Time Point
End Relative to Reference Time Point
Start Reference Time Point
End Reference Time Point
End Relative to Reference Period
Completion Status
Analysis Date
Analysis Relative Day
SMQ 02 Name
SMQ 02 Code
SMQ 02 Scope
SMQ 02 Scope (N)
SMQ 03 Name
SMQ 03 Code
SMQ 03 Scope
SMQ 03 Scope (N)
SMQ 05 Name
SMQ 05 Code
SMQ 05 Scope
SMQ 05 Scope (N)
Customized Query 01 Name
Customized Query 04 Name
Customized Query 04 Code
Response of Med Hx (past or current)
1st Occur w/in Trt Prd FL
1st Occur of SOC w/in Trt Prd FL
1st Occur of PT w/in Trt Prd FL
Generated from admiral package (template ad_admh.R).
None
data("admh")data("admh")
Nervous System Analysis Dataset
adnv_neuroadnv_neuro
A data frame with 43 columns:
Study Identifier
Unique Subject Identifier
Domain Abbreviation
Analysis Sequence Number
Age
Sex
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter (N)
Parameter
Parameter Code
Analysis Value
Baseline Value
Baseline Type
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
Sequence Number
Link ID
Short Name of Nervous System Test
Name of Nervous System Test
Category for Nervous System Test
Location Used for the Measurement
Vendor Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Method of Test or Examination
Last Observation Before Exposure Flag
Visit Number
Visit Name
Date/Time of Collection
Study Day of Visit/Collection/Exam
Contains a set of 2 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| UPSITPC | Percentile derived from UPSIT total score |
| UPSITTS | UPSIT Combined Score from 40 Odorant |
Generated from admiralneuro package (template ad_adnv.R).
None
data("adnv_neuro")data("adnv_neuro")
Exam Analysis for Ophthalmology
adoe_ophthaadoe_ophtha
A data frame with 103 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Parameter
Parameter Code
Parameter (N)
Analysis Value
Analysis Value (C)
Analysis Value Unit
Baseline Value
Baseline Value (C)
Baseline Type
Change from Baseline
Percent Change from Baseline
Derivation Type
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
On Treatment Record Flag
Sequence Number
Category for Ophthalmic Test or Exam
Subcategory for Ophthalmic Test or Exam
Date/Time of Collection
Visit Name
Visit Number
Planned Study Day of Visit
Numeric Result/Finding in Standard Units
Character Result/Finding in Std Format
Result or Finding in Original Units
Name of Ophthalmic Test or Exam
Short Name of Ophthalmic Test or Exam
Ophthalmic Test or Exam Detail
Laterality
Location Used for the Measurement
Study Day of Visit/Collection/Exam
Method of Test or Examination
Original Units
Standard Units
Completion Status
Planned Time Point Name
Planned Time Point Number
Study Eye Location
Affected Eye
Worst Post Baseline Obs
Contains a set of 8 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| FCSUBTH | Fellow Eye Center Subfield Thickness (um) |
| FDRSSR | Fellow Eye Diabetic Retinopathy Severity |
| FIOP | Fellow Eye IOP (mmHg) |
| FIOPCHG | Fellow Eye IOP Pre to Post Dose Diff (mmHg) |
| SCSUBTH | Study Eye Center Subfield Thickness (um) |
| SDRSSR | Study Eye Diabetic Retinopathy Severity |
| SIOP | Study Eye IOP (mmHg) |
| SIOPCHG | Study Eye IOP Pre to Post Dose Diff (mmHg) |
Generated from admiralophtha package (template ad_adoe.R).
None
data("adoe_ophtha")data("adoe_ophtha")
Pharmacokinetic Concentrations
adpcadpc
A data frame with 128 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Under 30 Group
Over 30 Group
Domain for Date of Death Collection
Over 30 plus 30 days Group
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Planned Treatment Dose
Actual Treatment Dose
Treatment Dose Units
Analysis Date
Analysis Time
Analysis Datetime
Analysis Relative Day
Analysis Time Imputation Flag
Analysis Start Date
Analysis Start Time
Analysis Start Datetime
Analysis End Date
Analysis End Time
Analysis End Datetime
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Analysis Timepoint Reference
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Analysis Value
Analysis Value Unit
Analysis Value Category 1
Baseline Value
Baseline Type
Change from Baseline
Derivation Type
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
Source Data
Source Variable
Source Sequence Number
Nom. Rel. Time from Analyte First Dose
Pharmacokinetic Test Short Name
Pharmacokinetic Test Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Vendor Name
Specimen Material Type
Lower Limit of Quantitation
Visit Name
Visit Number
Planned Study Day of Visit
Date/Time of Specimen Collection
Actual Study Day of Specimen Collection
Planned Time Point Name
Planned Time Point Number
First Datetime of Dose for Analyte
Act. Rel. Time from Analyte First Dose
Actual Rel. Time from Ref. Dose
Reference Datetime of Dose for Analyte
First Date of Dose for Analyte
First Time of Dose for Analyte
Reference Date of Dose for Analyte
Reference Time of Dose for Analyte
Nominal Rel. Time from Ref. Dose
Rel. Time from First Dose Unit
Rel. Time from Ref. Dose Unit
Analysis Lower Limit of Quantitation
Modified Rel. Time from Ref. Dose
Numeric Result/Finding in Standard Units
Standard Units
Numeric Result/Finding in Standard Units
Standard Units
Baseline Body Mass Index (kg/m2)
BMI at Baseline (Unit)
Contains a set of 2 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| DOSE | Xanomeline Patch Dose |
| XAN | Pharmacokinetic concentration of Xanomeline |
Generated from admiral package (template ad_adpc.R).
None
data("adpc")data("adpc")
Pharmacokinetic Parameters
adppadpp
A data frame with 79 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter Code
Numeric Result/Finding in Standard Units
Analysis Value Category 1
Analysis Value Category 1 (N)
Domain Abbreviation
Source Variable
Sequence Number
Parameter Short Name
Parameter Name
Parameter Category
Result or Finding in Original Units
Original Units
Standard Units
Specimen Material Type
Date/Time of Reference Point
Visit Name
Visit Number
Parameter Category
Standard Units
Generated from admiral package (template ad_adpp.R).
None
data("adpp")data("adpp")
Population Pharmacokinetic
adppkadppk
A data frame with 61 columns:
Project Identifier
Project Identifier (N)
Study Identifier
Study Identifier (N)
Unique Subject Identifier
Unique Subject Identifier (N)
Subject Identifier for the Study
Subject Identifier for the Study (N)
Study Site Identifier
Study Site Identifier (N)
Record Sequence
Act. Rel. Time from Analyte First Dose
Actual Rel Time from Previous Dose
Nom. Rel. Time from Analyte First Dose
Nominal Rel Time from Previous Dose
Event ID
Compartment
Dependent Variable Result
Parameter Code
Parameter
Parameter (N)
Analysis Sequence Number
Analysis Value
Analysis Value Unit
Missing Dependent Variable Result
Analysis Lower Limit of Quantitation
Below Lower Limit of Quant Flag
Below Lower Limit of Quant Flag (N)
Actual Amount of Dose Received (unit)
Actual Treatment Dose
Dosing Interval (unit)
Steady State
Drug Formulation
Drug Formulation (N)
Route of Administration
Route of Administration (N)
Cohort Subject Enrolled Into
Description of Planned Arm
Date/Time
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Baseline Body Mass Index (kg/m2)
Numeric Result/Finding in Standard Units
Age
Sex
Sex (N)
Race
Race (N)
Ethnicity
Ethnicity (N)
Country
Country Name
Country (N)
Numeric Result/Finding in Standard Units
Baseline Creatinine Clearance
Age
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Numeric Result/Finding in Standard Units
Planned Treatment Dose
Log DV
Contains a set of 2 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| DOSE | Xanomeline Patch Dose |
| XAN | Pharmacokinetic concentration of Xanomeline |
Generated from admiral package (template ad_adppk.R).
None
data("adppk")data("adppk")
Tumor Response Analysis
adrs_oncoadrs_onco
A data frame with 79 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Date Imputation Flag
Analysis Visit
Parameter
Parameter Code
Parameter Category 1
Parameter Category 2
Parameter Category 3
Analysis Value
Analysis Value (C)
Analysis Flag 01
Analysis Flag 02
Visit Number
Visit Name
Assessment Short Name
Assessment Name
Result or Finding in Original Units
Character Result/Finding in Std Format
Evaluator
Evaluator Identifier
Accepted Record Flag
Date/Time of Assessment
Sequence Number
Date of Death Imputation Flag
Contains a set of 13 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| BCP | Best Overall Response of CR/PR by Investigator (confirmation not required) |
| BOR | Best Overall Response by Investigator (confirmation not required) |
| CB | Clinical Benefit by Investigator (confirmation for response not required) |
| CBCP | Best Confirmed Overall Response of CR/PR by Investigator |
| CBOR | Best Confirmed Overall Response by Investigator |
| CCB | Confirmed Clinical Benefit by Investigator |
| CRSP | Confirmed Response by Investigator |
| DEATH | Death |
| LSTA | Last Disease Assessment by Investigator |
| MDIS | Measurable Disease at Baseline by Investigator |
| OVR | Overall Response by Investigator |
| PD | Disease Progression by Investigator |
| RSP | Response by Investigator (confirmation not required) |
Generated from admiralonco package (template ad_adrs.R).
None
data("adrs_onco")data("adrs_onco")
Subject Level Analysis
adsladsl
A data frame with 55 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Date/Time of Birth
Generated from admiral package (template ad_adsl.R).
None
data("adsl")data("adsl")
Subject Level Analysis for Vaccine
adsl_vaccineadsl_vaccine
A data frame with 46 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country/Region
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Geographic Region 1
Date/Time of Birth
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Per-Protocol Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Planned Treatment for Period 02
Actual Treatment for Period 02
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Period 01 Start Date
Period 01 End Date
Period 02 Start Date
Period 02 End Date
Date/Time of Informed Consent
Investigator Identifier
Investigator Name
Vaccination Date 01
Vaccination Date 02
Generated from admiralvaccine package (template ad_adsl.R).
None
data("adsl_vaccine")data("adsl_vaccine")
Tau PET Scan Analysis Dataset
adtpet_neuroadtpet_neuro
A data frame with 46 columns:
Study Identifier
Unique Subject Identifier
Domain Abbreviation
Analysis Sequence Number
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Analysis Value
Analysis Value (C)
Baseline Value
Baseline Value (C)
Baseline Type
Change from Baseline
Percent Change from Baseline
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
On Treatment Record Flag
Sequence Number
Link ID
Short Name of Nervous System Test
Name of Nervous System Test
Category for Nervous System Test
Location Used for the Measurement
Vendor Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Method of Test or Examination
Last Observation Before Exposure Flag
Reference Region
Reported Agent Name
Category for Agent
Visit Number
Visit Name
Date/Time of Collection
Study Day of Visit/Collection/Exam
Contains a set of 2 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| SUVRAFTP | AVID FTP Standard Uptake Ratio Neocortical Composite Inferior Cerebellar Gray Matter |
| SUVRBFTP | BERKELEY FTP Standard Uptake Ratio Neocortical Composite Inferior Cerebellar Gray Matter |
Generated from admiralneuro package (template ad_adtpet.R).
None
data("adtpet_neuro")data("adtpet_neuro")
Tumor Results Analysis for Oncology
adtr_oncoadtr_onco
A data frame with 99 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Pharmacodynamic Analysis Set Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Date Imputation Flag
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Parameter Category 1
Parameter Category 2
Parameter Category 3
Analysis Value
Baseline Value
Change from Baseline
Percent Change from Baseline
NADIR
Change from NADIR
Percent Change from NADIR
Baseline Record Flag
Analysis Flag 01
Analysis Flag 02
Analysis Flag 03
Analysis Flag 04
Sequence Number
Group ID
Link ID
Tumor/Lesion Assessment Short Name
Tumor/Lesion Assessment Test Name
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Evaluator
Evaluator Identifier
Accepted Record Flag
Visit Number
Visit Name
Date/Time of Tumor/Lesion Measurement
Location of the Tumor/Lesion
Tumor Site Group 1
Lesion IDs Expected
Lesion IDs Assessed
Date of Death Imputation Flag
Contains a set of 11 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| LDIAM1 | Target Lesion 1 Analysis Diameter |
| LDIAM2 | Target Lesion 2 Analysis Diameter |
| LDIAM3 | Target Lesion 3 Analysis Diameter |
| LDIAM4 | Target Lesion 4 Analysis Diameter |
| LDIAM5 | Target Lesion 5 Analysis Diameter |
| NLDIAM1 | Target Lesion 1 Analysis Perpendicular |
| NLDIAM2 | Target Lesion 2 Analysis Perpendicular |
| NLDIAM3 | Target Lesion 3 Analysis Perpendicular |
| NLDIAM4 | Target Lesion 4 Analysis Perpendicular |
| NLDIAM5 | Target Lesion 5 Analysis Perpendicular |
| SDIAM | Target Lesions Sum of Diameters by Investigator |
Generated from admiralonco package (template ad_adtr.R).
None
data("adtr_onco")data("adtr_onco")
Time to Event Analysis for Oncology
adtte_oncoadtte_onco
A data frame with 20 columns:
Study Identifier
Unique Subject Identifier
Analysis Sequence Number
Age
Sex
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Analysis Date
Parameter
Parameter Code
Analysis Value
Time-to-Event Origin Date for Subject
Censor
Event or Censoring Description
Censor Date Description
Source Data
Source Variable
Source Sequence Number
Contains a set of 3 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| OS | Overall Survival |
| PFS | Progression Free Survival |
| RSD | Duration of Response |
Generated from admiralonco package (template ad_adtte.R).
None
data("adtte_onco")data("adtte_onco")
Visual Function Questionnaire Analysis
advfq_ophthaadvfq_ophtha
A data frame with 89 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Parameter
Parameter Code
Parameter Category 1
Parameter Category 2
Analysis Value
Analysis Value (C)
Baseline Value
Change from Baseline
Percent Change from Baseline
Baseline Record Flag
Analysis Flag 01
On Treatment Record Flag
Sequence Number
Question Short Name
Question Name
Category of Question
Subcategory for Question
Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Finding in Standard Units
Standard Units
Baseline Flag
Derived Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Finding
Study Day of Finding
Contains a set of 11 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| QBCSCORE | Composite Score |
| QR01 | Recoded Item - 01 |
| QR02 | Recoded Item - 02 |
| QR03 | Recoded Item - 03 |
| QR04 | Recoded Item - 04 |
| QSG01 | General Score 01 |
| QSG02 | General Score 02 |
| VFQ1 | Overall Health |
| VFQ2 | Eyesight in Both Eyes |
| VFQ3 | Worry About Eyesight |
| VFQ4 | Pain in and Around Eyes |
Generated from admiralophtha package (template ad_advfq.R).
None
data("advfq_ophtha")data("advfq_ophtha")
Vital Signs Analysis
advsadvs
A data frame with 105 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment
Actual Treatment
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Parameter
Parameter Code
Parameter (N)
Analysis Value
Analysis Value Category 1
Analysis Value Category 1 (N)
Baseline Value
Baseline Type
Change from Baseline
Percent Change from Baseline
Derivation Type
Analysis Reference Range Indicator
Baseline Reference Range Indicator
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Analysis Range 1 Lower Limit
Analysis Range 1 Upper Limit
Baseline Record Flag
Analysis Flag 01
On Treatment Record Flag
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Contains a set of 9 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| BMI | Body Mass Index(kg/m^2) |
| BSA | Body Surface Area(m^2) |
| DIABP | Diastolic Blood Pressure (mmHg) |
| HEIGHT | Height (cm) |
| MAP | Mean Arterial Pressure (mmHg) |
| PULSE | Pulse Rate (beats/min) |
| SYSBP | Systolic Blood Pressure (mmHg) |
| TEMP | Temperature (C) |
| WEIGHT | Weight (kg) |
Generated from admiral package (template ad_advs.R).
None
data("advs")data("advs")
Vital Signs Analysis for Metabolic
advs_metabolicadvs_metabolic
A data frame with 101 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Screen Failure Date
Final Retrieval Visit Date
Date/Time of Death
Relative Day of Death
Subject Death Flag
Elapsed Days from Last Dose to Death
Last Dose to Death - Days Elapsed Grp 1
Death Within 30 Days of Last Trt Flag
Death After 30 Days from Last Trt Flag
Domain for Date of Death Collection
Death Within 30 Days of First Trt Flag
Analysis Sequence Number
Geographic Region 1
Date/Time of Collection
Study Day of Collection
Age
Age Units
Pooled Age Group 1
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
End of Study Status
End of Study Date
Date/Time of Informed Consent
Date of Randomization
Date Last Known Alive
Total Treatment Duration (Days)
Date of Death
Date of Death Imputation Flag
Cause of Death
Cause of Death Reason 1
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Parameter Category 1 (N)
Analysis Value
Analysis Value Category 1
Analysis Value Category 1 (N)
Baseline Value
Baseline Category 1
Baseline Category 1 (N)
Change from Baseline
Percent Change from Baseline
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Analysis Criterion 2
Criterion 2 Evaluation Result Flag
Baseline Record Flag
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Contains a set of 10 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| BMI | Body Mass Index (kg/m2) |
| DIABP | Diastolic Blood Pressure (mmHg) |
| HEIGHT | Height (cm) |
| HIPCIR | Hip Circumference (cm) |
| PULSE | Pulse Rate (beats/min) |
| SYSBP | Systolic Blood Pressure (mmHg) |
| TEMP | Temperature (C) |
| WAISTHIP | Waist to Hip Ratio |
| WEIGHT | Weight (kg) |
| WSTCIR | Waist Circumference (cm) |
Generated from admiralmetabolic package (template ad_advs.R).
None
data("advs_metabolic")data("advs_metabolic")
Vital Signs Analysis for Pediatrics
advs_pedsadvs_peds
A data frame with 80 columns:
Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Study Site Identifier
Country
Domain Abbreviation
Subject Reference Start Date/Time
Subject Reference End Date/Time
Date/Time of First Study Treatment
Date/Time of Last Study Treatment
Date/Time of End of Participation
Date/Time of Death
Subject Death Flag
Analysis Sequence Number
Date/Time of Birth (Character)
Date/Time of Birth
Date/Time of Collection
Study Day of Collection
Age
Age Units
Sex
Race
Ethnicity
Description of Planned Arm
Planned Arm Code
Description of Actual Arm
Actual Arm Code
Planned Treatment for Period 01
Actual Treatment for Period 01
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Time of First Exposure Imput. Flag
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Time of Last Exposure Imput. Flag
Date/Time of Informed Consent
Total Treatment Duration (Days)
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Analysis Timepoint (N)
Parameter
Parameter Code
Parameter (N)
Analysis Value
Baseline Value
Change from Baseline
Percent Change from Baseline
Baseline Record Flag
Analysis Flag 01
On Treatment Record Flag
Epoch
Evaluator
Sequence Number
Vital Signs Test Short Name
Vital Signs Test Name
Vital Signs Position of Subject
Result or Finding in Original Units
Original Units
Character Result/Finding in Std Format
Numeric Result/Finding in Standard Units
Standard Units
Completion Status
Location of Vital Signs Measurement
Baseline Flag
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Measurements
Study Day of Vital Signs
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Current Analysis Age (Days)
Current Analysis Age Units
Temporary Height at Timepoint
Temporary Height at Timepoint Units
Contains a set of 14 unique Parameter Codes and Parameters:
| PARAMCD | PARAM |
| BMI | Body Mass Index(kg/m^2) |
| BMIPCTL | BMI-for-age percentile |
| BMISDS | BMI-for-age z-score |
| HDCIRC | Head Circumference (cm) |
| HDCPCTL | Head Circumference-for-age percentile |
| HDCSDS | Head Circumference-for-age z-score |
| HEIGHT | Height (cm) |
| HGTPCTL | Height-for-age percentile |
| HGTSDS | Height-for-age z-score |
| WEIGHT | Weight (kg) |
| WGTAPCTL | Weight-for-age percentile |
| WGTASDS | Weight-for-age z-score |
| WGTHPCTL | Weight-for-length/height Percentile |
| WGTHSDS | Weight-for-length/height Z-Score |
Generated from admiralpeds package (template ad_advs.R).
None
data("advs_peds")data("advs_peds")