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Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study Identifiertext
ReqAE.STUDYID
USUBJIDUnique Subject Identifiertext
ReqAE.USUBJID
ASTDTAnalysis Start Dateinteger
Cond

Created from converting AE.AESTDTC from character ISO8601 format to numeric date format

ASTDTMAnalysis Start Date/Timeinteger
CondCreated from converting AE.AESTDTC from character ISO8601 format to numeric datetime format
AENDTAnalysis End Dateinteger
Cond

Created from converting AE.AEENDTC from character ISO8601 format to numeric date format

AENDTMAnalysis End Date/Timeinteger
CondCreated from converting AE.AEENDTC from character ISO8601 format to numeric datetime format
ASTDYAnalysis Start Relative Dayinteger
CondASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT
AENDYAnalysis End Relative Dayinteger
CondAENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT
PREFLPre-treatment FlagtextYCondIf ASTDT < ADSL.TRTSDT then PREFL=’Y’
TRTEMFLTreatment Emergent Analysis FlagtextYCondIf ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’
FUPFLFollow-up FlagtextYCondIf ASTDT > ADSL.TRTEDT then FUPFL=’Y’

AETRTEMTreatment Emergent Flagtext(NY)PermSUPPAE.QVAL where QNAM=’AETRTEM’.
AOCCFL1st Occurrence within Subject FlagtextYPermSort the data in the required order and flag the first treatment emergent record for each subject.
AOCCPFL1st Occurrence of Preferred Term FlagtextYPermSort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject.
AOCCSFL1st Occurrence of SOC FlagtextYPerm Sort the data in the required order and flag the first treatment emergent record for each body system for each subject.
AESERSerious Eventtext(NY)ReqAE.AESER
AERELCausalitytext
PermAE.AEREL
RELGR1Pooled Causality Group ytext
Permset to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT)
AEACNAction Taken with Study Treatmenttext(ACN)PermAE.AEACN
TRTPPlanned Treatmenttext
CondADSL.TRT01P
TRTAActual Treatmenttext
CondADSL.TRT01A
SAFFLSafety Population Flagtext
CondADSL.SAFFL
TRTSDTDate of First Exposure to Treatmentinteger
PermADSL.TRTSDT
TRTEDTDate of Last Exposure to Treatmentinteger
PermADSL.TRTEDT
AETERMReported Term for the Adverse Eventtext
ReqAE.AETERM
AEBODSYSBody System or Organ Classtext
ReqAE.AEBODSYS
AEDECODDictionary-Derived Termtext
ReqAE.AEDECOD
AEOUTOutcome of Adverse Eventtext
PermAE.AEOUT
AESEQSequence Numberinteger
PermAE.AESEQ
AESTDTCStart Date/Time of
Adverse Event

text


PermAE.AESTDTC
AEENDTCEnd Date/Time of
Adverse Event		text
PermAE.AEENDTC
AESTDYStudy Day of Start of
Adverse Event		text
PermAE.AESTDY
AEENDYStudy Day of End of
Adverse Event		text
PermAE.AEENDY
AEENRFEnd Relative to
Reference Period		text
PermAE.AEENRF

STUDYID

USUBJIDASTDTASTDTMAENDTAENDTMASTDYAENDYPREFLTRTEMFLFUPFLAETRTEMAOCCFLAOCCPFLAOCCSFLAESERAERELRELGR1AESEVAEACNTRTASAFFLTRTSDTTRTEDTAETERMAEBODSYSAEDECODAEOUTAESEQAESTDTCAEENDTCAESTDYAEENDYAEENRF
ABC12312310112OCT2005
12OCT2005
-1-1Y





NDEFINITELY NOT RELATEDNOT RELATEDSEVERENOT APPLICABLEProduct AY13OCT200520OCT2005POUNDING HEADACHENervous system disordersHeadacheRECOVERED/RESOLVED12005-10-122005-10-12-1-1
ABC12312310113OCT200513OCT2005:13:0513OCT200513OCT2005:19:0011
Y
YYYYNProduct ARELATEDMODERATEDOSE REDUCEDProduct AY13OCT200520OCT2005BACK PAIN FOR 6 HOURSMusculoskeletal and connective tissue disordersBack painRECOVERED/RESOLVED22005-10-13T13:052005-10-13T19:0011
ABC12312310121OCT2005


9

YYY
YYYPROBABLY NOT RELATEDNOT RELATEDMODERATEDOSE REDUCEDProduct AY13OCT200520OCT2005PULMONARY EMBOLISMVascular disordersPulmonary embolismRECOVERING/RESOLVING32005-10-21
9
AFTER
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