Adverse Events Analysis
adaeA 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
None