| Title: | J&J Innovative Medicine ADaM Test Data |
|---|---|
| Description: | A set of Analysis Data Model (ADaM) datasets constructed by modifying the ADaM datasets in the 'pharmaverseadam' package to meet J&J Innovative Medicine's standard data structure for Clinical and Statistical Programming. |
| Authors: | David Munoz Tord [aut, cre], Nicholas Masel [aut], Joe Kovach [aut], Mahesh Divakaran [ctb], J&J Innovative Medicine [cph, fnd] |
| Maintainer: | David Munoz Tord <[email protected]> |
| License: | Apache License (>= 2) |
| Version: | 0.0.5 |
| Built: | 2026-06-07 06:14:37 UTC |
| Source: | https://github.com/cran/pharmaverseadamjnj |
adae modified from pharmaverseadam
adaeadae
A data frame with 1191 rows and 81 variables:
Unique Subject Identifier
Domain Abbreviation
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 at Record Start
Treatment Dose Units
Standard Toxicity Grade
Standard Toxicity Grade (N)
Action Taken with Study Treatment
Day of Study Drug
Concomitant or Additional Trtmnt Given
Customized Query 01 Name
Customized Query 02 Name
Customized Query 03 Name
Other Medically Important Serious Event
Serious Event
Causality
Outcome of Adverse Event
Analysis Category 1
1st Occurrence within Subject Flag
1st Occurrence within Preferred Term Flag
1st Occurrence of SOC Flag
Actual Treatment for Period 01
Safety Population Flag
Age
Sex
Race
Race
Study Identifier
Pooled Age Group 1
Treatment Relative End Day
Planned Treatment for Period 01
Treatment Discontinued Flag
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adae"))head(data("adae"))
adae modified from pharmaverseadam to include Office of New Drugs (OND) Custom Medical Queries
adaeocmqadaeocmq
A data frame with 1972 rows and 86 variables:
Unique Subject Identifier
Domain Abbreviation
Sequence Number
Reported Term for the Adverse Event
AEDECOD
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 at Record Start
Treatment Dose Units
Standard Toxicity Grade
Standard Toxicity Grade (N)
Action Taken with Study Treatment
Day of Study Drug
Concomitant or Additional Trtmnt Given
Customized Query 01 Name
Customized Query 02 Name
Customized Query 03 Name
Other Medically Important Serious Event
Serious Event
Causality
Outcome of Adverse Event
Analysis Category 1
1st Occurrence within Subject Flag
1st Occurrence within Preferred Term Flag
1st Occurrence of SOC Flag
Actual Treatment for Period 01
Safety Population Flag
Age
Sex
Race
Race
Study Identifier
Pooled Age Group 1
Treatment Relative End Day
Planned Treatment for Period 01
Treatment Discontinued Flag
Custom Medical Query Name
Custom Medical Query System Organ Class
Custom Medical Query Scope
Gender Specific OCMQ Male Flag
Gender Specific OCMQ Female Flag
data from adae from pharmaverseadam and, FDA_OCMQ_Consolidated_List.rds and FDA_OCMQ_References.rds
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adaeocmq"))head(data("adaeocmq"))
adagocmq modified from pharmaverseadam
adagocmqadagocmq
A data frame with 1301 rows and 27 variables:
Study Identifier
Unique Subject Identifier
Analysis Start Date
Analysis Start Relative Day
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Analysis Category 1
Analysis Category 1 (N)
Analysis Term (N)
Analysis Term
Hypersensitivity Category
Source Value
Source Variable
Source Data
Source Sequence Number
Analysis Flag 01
Age
Age Units
Sex
Race
Country
Randomized Flag
Safety Population Flag
Study Site Identifier
Subject Identifier for the Study
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adagocmq"))head(data("adagocmq"))
adcm modified from pharmaverseadam
adcmadcm
A data frame with 7276 rows and 63 variables:
Unique Subject Identifier
Domain Abbreviation
Planned Treatment
Actual Treatment
Phase
Description of Phase N
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
Preferred ATC Text for ATC Level 1
Preferred ATC Text for ATC Level 2
Preferred ATC Text for ATC Level 3
Preferred ATC Text for ATC Level 4
Base Preferred Term
CM Pre-specified
CM Occurrence
Indication Specification
Dose Description
End Relative to Reference Period
Customized Query 01 Name
Customized Query 02 Name
Customized Query 03 Name
Customized Query 04 Name
Customized Query 05 Name
Customized Query 06 Name
Customized Query 07 Name
Actual Treatment for Period 01
Safety Population Flag
Date of First Exposure to Treatment
Study Identifier
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adcm"))head(data("adcm"))
addili modified from pharmaverseadam
addiliaddili
A data frame with 10476 rows and 71 variables:
Study Identifier
Unique Subject Identifier
Parameter Code
Parameter
Analysis Date
Analysis Date/Time
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Timepoint
Planned Treatment
Actual Treatment
Analysis Value
Baseline Value
Analysis Reference Range Indicator
Baseline Reference Range Indicator
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Baseline Record Flag
Post-Baseline Record Flag
On Treatment Record Flag
Sequence Number
Visit Name
Visit Number
Laboratory Name
Derivation Type
Planned Treatment for Period 01
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01
Actual Treatment for Period 01 (N)
Date of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Age
Age Units
Pooled Age Group 1
Pooled Age Group 1 (N)
Sex
Race
Country
Safety Population Flag
Full Analysis Set Population Flag
Randomized Population Flag
Subject Death Flag
Study Site Identifier
Subject Identifier for the Study
Parameter Category 1
Ratio to ANR Upper Limit
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 04 Record Flag
Analysis 06 Record Flag
Analysis 05 Record Flag
Analysis 07 Record Flag
Analysis 02 Record Flag
Analysis 03 Record Flag
Analysis Value (C)
Analysis Value Category 1
Analysis Value Category 1 (N)
Analysis Value Category 2
Analysis Value Category 2 (N)
Analysis Sequence Number
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("addili"))head(data("addili"))
adeg modified from pharmaverseadam
adegadeg
A data frame with 13536 rows and 71 variables:
Unique Subject Identifier
Domain Abbreviation
Analysis Sequence Number
Planned Treatment
Actual Treatment
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 (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
Analysis Normal Range Lower Limit
Analysis Normal Range Upper Limit
Baseline Record Flag
Analysis Flag 01-Analysis Value
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
Treatment Emergent Analysis Flag
Analysis Flag 02-By Visit Value
Analysis Flag 03-Maximum Value
Post-Baseline Record Flag
Analysis Criterion 1
Criterion 1 Evaluation Result Flag
Analysis Criterion 2
Criterion 2 Evaluation Result Flag
Clinically Significant
Baseline Value
Baseline Reference Range Indicator
Baseline Category 1
Actual Treatment for Period 01
Safety Population Flag
Study Identifier
Age
Sex
Race
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adeg"))head(data("adeg"))
adex modified from pharmaverseadam
adexadex
A data frame with 591 rows and 128 variables:
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
Age Group
Sex
Race
Pooled Race Group 1
Ethnicity
Safety Population Flag
Treatment Group
Treatment Category Code
Actual Treatment Group
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
Adjusted 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
Analysis name of Treatment
Date of Exposure
Lot Number
Analysis Dose
Planned Treatment for Period 01 (N)
Visit Number
Visit Label
Actual Treatment for Period 01 (N)
Analysis Occurrence
Race
Analysis Category 1
Analysis Reason for Occur Value
Other Analysis Reason for Occur Value
Analysis Reason for Dose Adjustment
Other Anal Reason for Dose Adjust Prior
Analysis Reason for Dose Adjustment Prior
Analysis Action Taken During Study Trt
Act Takn Dur Infus-Full Dose Admined
Act Takn Dur Infus-Infusion Aborted
Act Takn Dur Infus-Infusion Interrupted
Act Takn Dur Infus-Infusion Rate Decrsed
Act Takn Dur Infus-Infusion Rate Incrsed
Other Anal Reason for Dose Adjustment
Analysis Category 2
Action Taken Prior to Infusion Start
Action Taken Prior to Infusion Start
Analysis Scheduled Dose
Analysis Scheduled Dose Units
Analysis Dose Form
Analysis Dose Units
Analysis Dosing Frequency per Interval
Analysis Route of Administration
Analysis Total Volume Infused
Analysis Total Volume Infused Units
Analysis Infusion Rate
Analysis Infusion Rate Unit
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adex"))head(data("adex"))
adex modified from pharmaverseadam
adexsumadexsum
A data frame with 2794 rows and 25 variables:
Unique Subject Identifier
Parameter Code
Parameter
Analysis Value
Analysis Value Category 1
Analysis Value Category 1 (N)
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 Visit
Analysis Visit (N)
Actual Treatment for Period 01
Safety Population Flag
Study Identifier
data from adex from pharmaverseadam
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adexsum"))head(data("adexsum"))
adlb modified from pharmaverseadam
adlbadlb
A data frame with 83640 rows and 156 variables:
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
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
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01 (N)
Analysis Value - Units
Analysis Record Flag 02-Analysis Value
Treatment Emergent Analysis Flag
Country
Race Description
Ethnicity Description
Parameter Category 2
Parameter Category 3
Parameter Category 4
Parameter Category 5
Parameter Category 6
Multi-Response Criterion 2 Evaluation
Multi-Response Criterion 1 Evaluation
Multi-Response Criterion 1 Eval (N)
Multi-Response Criterion 2 Eval (N)
Analysis Multi-Response Criterion 1
Analysis Multi-Response Criterion 2
Post-Baseline Record Flag
Reference Limit Higher
Reference Limit Lower
Analysis Toxicity Grade (Numeric)
Analysis Date/Time
Analysis Timepoint
Clinically Significant
Start Date of Treatment for Period 01
End Date of Treatment for Period 01
Specimen Type
Fasting Status
Laboratory Name
Analysis Record Flag 03 - Protocol Visit
Analysis Flag 04
Analysis Flag 05
Analysis Flag 06
Analysis Flag 07
Analysis Flag 08
Analysis Flag 09
Analysis Flag 10
Analysis Flag 14
Analysis Flag 15
Analysis Flag 16
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adlb"))head(data("adlb"))
adpc modified from pharmaverseadam
adpcadpc
A data frame with 4479 rows and 130 variables:
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)
Concentrations Below the Lowest Quantification Level Criterion
Concentrations Below the Lowest Quantification Level Flag
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adpc"))head(data("adpc"))
adsl modified from pharmaverseadam
adsladsl
A data frame with 306 rows and 110 variables:
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
Planned Treatment for Period 01 (N)
Actual Treatment for Period 01 (N)
Pooled Age Group 1 (N)
Sex
Weight (kg)
Weight Group 1 (N)
Weight Group 1
Height (cm)
Body surface area (m2)
Body mass index (kg/m2)
BMI at Baseline Group 1 (N)
BMI at Baseline Group 1
Country
Race
Date of Informed Consent
Ethnicity
Strat Factor 1 Value Used for Rand
Strat Factor 2 Value Used for Rand
Randomization Number
Datetime of Randomization
End of Treatment Status
Reason for Discontinuation of Treatment
Last Treatment Visit
Reason Specify for Discont of Treatment
End of Study Date
Reason for Discontinuation from Study
Reason Spec for Discont from Study
Last Study Visit
Treatment Relative End Day
Screened Population Flag
Screen Failure Flag
Reason for Discont During Screening
Enrolled Population Flag
Randomized Flag
Intent-To-Treat Population Flag
Full Analysis Set Population Flag
Per-Protocol Population Flag
Last Subject Visit (SV) Date
Study Day of Study Termination
Subject Blind Broken
Re-screened Flag
Death on Treatment Flag
Cause Spec for Death
Death After 30 Days of Last Treatment
Death Within 60 Days of First Treatment
Study Day of Unblinding
Reason For Unblinding
Last Dose
Last Dose Unit
Reported Cause of Death
Days from Last Dose to Death
Study Day of Death
Pharmacokinetic Population Flag
History of Diabetes
Study Day of Treatment Discontinuation
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adsl"))head(data("adsl"))
adtte_onc modified from pharmaverseadam
adttesafadttesaf
A data frame with 2032 rows and 9 variables:
Unique Subject Identifier
Parameter Code
Parameter
Analysis Value
Censor
Start Date
Analysis Date
Actual Treatment for Period 01
Safety Population Flag
data from adtte_onc from pharmaverseadam
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("adttesaf"))head(data("adttesaf"))
advs modified from pharmaverseadam
advsadvs
A data frame with 40702 rows and 78 variables:
Unique Subject Identifier
Domain Abbreviation
Analysis Sequence Number
Planned Treatment
Actual Treatment
Analysis Date
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Analysis Time Point
Analysis Timepoint (N)
Parameter
Parameter Code
Parameter (N)
Analysis Value
Analysis Value Category 1
Analysis Value Category 1 (N)
Baseline Type
Change from Baseline
Percent Change from Baseline
Derivation Type
Analysis 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
Analysis Value (C)
Analysis Flag 02-By Visit Value
Post-Baseline Record Flag
Baseline Value
Baseline Reference Range Indicator
Analysis Date/Time
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 Toxicity Description Low
Analysis Toxicity Description High
Analysis Toxicity Grade Low
Analysis Toxicity Grade High
Analysis Toxicity Grade
Analysis Flag 06-Minimum Value
Analysis Flag 05-Worst Tox Grade High
Analysis Flag 04-Worst Value
Analysis Flag 03-Maximum Value
Treatment Emergent Analysis Flag
Actual Treatment for Period 01
Safety Population Flag
Study Identifier
Age
Sex
Race
data from pharmaverseadam.
adae adaeocmq adagocmq adcm addili adeg adex adexsum adlb adpc adsl adttesaf advs# nolint
head(data("advs"))head(data("advs"))