ADAE data created from subsetting the CDISC ADAE dataset
Format
A data frame with 84 rows and 55 variables:
- STUDYID
Study Identifier
- SITEID
Study Site Identifier
- USUBJID
Unique Subject Identifier
- SUBJID
Subject Identifier for the Study
- TRTA
Actual Treatment
- TRTAN
Actual Treatment (N)
- AGE
Age
- AGEGR1
Pooled Age Group 1
- AGEGR1N
Pooled Age Group 1 (N)
- RACE
Race
- RACEN
Race (N)
- SEX
Sex
- SAFFL
Safety Population Flag
- TRTSDT
Date of First Exposure to Treatment
- TRTEDT
Date of Last Exposure to Treatment
- ASTDT
Analysis Start Date
- ASTDTF
Analysis Start Date Imputation Flag
- ASTDY
Analysis Start Relative Day
- AENDT
Analysis End Date
- AENDY
Analysis End Relative Day
- ADURN
AE Duration (N)
- ADURU
AE Duration Units
- AETERM
Reported Term for the Adverse Event
- AELLT
Lowest Level Term
- AELLTCD
Lowest Level Term Code
- AEDECOD
Dictionary-Derived Term
- AEPTCD
Preferred Term Code
- AEHLT
High Level Term
- AEHLTCD
High Level Term Code
- AEHLGT
High Level Group Term
- AEHLGTCD
High Level Group Term Code
- AEBODSYS
Body System or Organ Class
- AESOC
Primary System Organ Class
- AESOCCD
Primary System Organ Class Code
- AESEV
Severity/Intensity
- AESER
Serious Event
- AESCAN
Involves Cancer
- AESCONG
Congenital Anomaly or Birth Defect
- AESDISAB
Persist or Signif Disability/Incapacity
- AESDTH
Results in Death
- AESHOSP
Requires or Prolongs Hospitalization
- AESLIFE
Is Life Threatening
- AESOD
Occurred with Overdose
- AEREL
Causality
- AEACN
Action Taken with Study Treatment
- AEOUT
Outcome of Adverse Event
- AESEQ
Sequence Number
- TRTEMFL
Treatment Emergent Analysis Flag
- AOCCFL
1st Occurrence of Any AE Flag
- AOCCSFL
1st Occurrence of SOC Flag
- AOCCPFL
1st Occurrence of Preferred Term Flag
- AOCC02FL
1st Occurrence 02 Flag for Serious
- AOCC03FL
1st Occurrence 03 Flag for Serious SOC
- AOCC04FL
1st Occurrence 04 Flag for Serious PT
- CQ01NAM
Customized Query 01 Name
- AOCC01FL
1st Occurrence 01 Flag for CQ01