ADAE data created from subsetting the CDISC ADAE dataset

ADAE data created from subsetting the CDISC ADAE dataset

Usage

cdisc_adae

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: First Occurrence of Any AE Flag
AOCCSFL: First Occurrence of SOC Flag
AOCCPFL: First Occurrence of Preferred Term Flag
AOCC02FL: First Occurrence 02 Flag for Serious
AOCC03FL: First Occurrence 03 Flag for Serious SOC
AOCC04FL: First Occurrence 04 Flag for Serious PT
CQ01NAM: Customized Query 01 Name
AOCC01FL: First Occurrence 01 Flag for CQ01

Source

CDISC SDTM/ADAM Pilot Project.