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Adverse Event Analysis Dataset (ADAE)

ADAE Data Set

The ADAE dataset contains 1191 rows and 55 columns.

ADAE Data Definition File

Variable LabelType
Controlled Term
RoleComment
USUBJIDUnique 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 -
AEDECODDictionary-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 -
DSREASAEDiscontinued 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 -
LSTDOSDTDate of Last Dose
date-
Support-
TRTDUR Duration of Treatment
float - Support In days
TRTSTDTStart Date of Treatment
date
-
Support
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Topic revision: r7 - 03 Apr 2012 - 14:07:06 - MaryBanach
 

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