Adverse Event Analysis Dataset (ADAE)

ADAE Data Set

The ADAE dataset contains 1191 rows and 55 columns.

ADAE Data Definition File

Variable Label Type
Controlled Term
Role Comment
USUBJID Unique Subject Identifier text - Identifier -
AESEQ Sequence Number float - Selection -
STUDYID Study Identifier text - Identifier -
DOMAIN Domain Abbreviation text - Identifier -
SITEID Study Site Identifier text - Identifier -
SUBJID Subject Identifier for Study text - Identifier -
AETERM Reported Term for AE text - Support -
AEDECOD Dictionary-Derived Term text - Selection -
AEBODSYS Body System or Organ Class text - Selection -
AESEV Severity/Intensity text SEV Selection -
AESER Serious Event text YNONLY Selection -
AESERN Serious Event, Numeric float YN_N Analysis -
AEREL Causality text AECAUS Selection -
DSREASAE Discontinued Due to AE? text Y_BLANK Selection -
ONTRTFL On or Off Study Treatment Flag text YNONLY Support -
TRTEMFL Treatment Emergent Flag text YNONLY Selection -
AEFN 1st AE Occurrence (1= Yes) float PRES Selection -
BODFN 1st Occurrence of SOC (1 = Yes) float PRES Selection -
DECODFN 1st Occurrence of PT (1 = Yes) float PRES Selection -
SAEFN 1st Serious AE Occurrence (1 = Yes) float PRES Selection -
SDECODFN 1st Serious PT Occurrence (1 = Yes) float PRES Selection -
SBODFN 1st Serious SOC Occurrence (1 = Yes) float PRES Selection -
AEDERMFN Special Dermatologic-Related Event (1 = Yes) float PRES Selection -
AESTDT Start Date/Time of AE date - Support -
AESTDTF Imputed Date Flag text DATEIMP Support -
AESTDY Study Day of Start of AE float - Selection -
ANLSTDY Analysis Start Day float - Timing -
AEENDT End Date/Time of AE date - Support -
AEENDY Study Day of End of AE float - Support -
TRTP !ADaM Description of Planned Arm text ARM Analysis -
TRTPCD !ADaM Planned Arm Code text ARMCD Analysis -
TRTPN ADam Planned Arm Code, Numeric float ARMCDN Analysis -
AGE Age in AGEU at RFSTDTC float - Covariate AGEU in Years
AGEGRP Age Group text AGEGRP Covariate -
AGEGRPN Age Group, Numeric float AGEGRPN Covariate -
RACE Race text ADRACE Covariate -
RACEN Race, Numeric float ADRACEN Covariate -
SEX Sex text SEX Covariate -
SAFETY Safety Population Flag text YNONLY Selection -
ITT Intent to Treat Population Flag text YNONLY Selection -
EFFICACY Efficacy Population Flag text YNONLY Selection -
COMPLT24 Completer of Week 24 Population Flag text YNONLY Selection -
AEDICT Coding Dictionary Information text - Support -
AESCAN Involves Cancer text YNONLY Support -
AESCONG Congenital Anomaly or Birth Defect text YNONLY Support -
AESDISAB Persist or Significant Disability/Incapacity text YNONLY Support -
AESDTH Results in Death text YNONLY Support -
AESHOSP Requires or Prolongs Hospitalization text YNONLY Support -
AESLIFE Is Life Threatening text YNONLY Support -
HLGTERM High Level Group Term text - Support -
HLTERM High Level Term text - Support -
LLTERM Lower Level Term text - Support -
LSTDOSDT Date of Last Dose date - Support -
TRTDUR Duration of Treatment float - Support In days
TRTSTDT Start Date of Treatment date - Support -

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