ADAE data created from subsetting the CDISC ADAE dataset
cdisc_adaeA data frame with 84 rows and 55 variables:
Study Identifier
Study Site Identifier
Unique Subject Identifier
Subject Identifier for the Study
Actual Treatment
Actual Treatment (N)
Age
Pooled Age Group 1
Pooled Age Group 1 (N)
Race
Race (N)
Sex
Safety Population Flag
Date of First Exposure to Treatment
Date of Last Exposure to Treatment
Analysis Start Date
Analysis Start Date Imputation Flag
Analysis Start Relative Day
Analysis End Date
Analysis End Relative Day
AE Duration (N)
AE Duration Units
Reported Term for the Adverse Event
Lowest Level Term
Lowest Level Term Code
Dictionary-Derived Term
Preferred Term Code
High Level Term
High Level Term Code
High Level Group Term
High Level Group Term Code
Body System or Organ Class
Primary System Organ Class
Primary System Organ Class Code
Severity/Intensity
Serious Event
Involves Cancer
Congenital Anomaly or Birth Defect
Persist or Signif Disability/Incapacity
Results in Death
Requires or Prolongs Hospitalization
Is Life Threatening
Occurred with Overdose
Causality
Action Taken with Study Treatment
Outcome of Adverse Event
Sequence Number
Treatment Emergent Analysis Flag
1st Occurrence of Any AE Flag
1st Occurrence of SOC Flag
1st Occurrence of Preferred Term Flag
1st Occurrence 02 Flag for Serious
1st Occurrence 03 Flag for Serious SOC
1st Occurrence 04 Flag for Serious PT
Customized Query 01 Name
1st Occurrence 01 Flag for CQ01
CDISC SDTM/ADAM Pilot Project.