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adae.xpt

Row

STUDYID

USUBJIDAETERMAEMODIFYAEDECODAEBODSYSASTDTAENDTASTDYAENDYPREFLTRTEMFLFUPFLAETRTEMAOCCFLAOCCPFLAOCCSFLAESERAERELAERLDEVRELGR1AESEVAEACNAEACNDEVAEOUTTRTASAFFLTRTSDTTRTEDTAESEQAESTDTCAEENDTCAESTDYAEENDYAEENRF
1A123A2001POUNDING HEADACHEHEADACHEHeadacheNervous system disorders21JAN202121JAN20211414
Y




NDEFINITELY NOT RELATED
NOT RELATEDSEVEREDOSE NOT CHANGED
RECOVERED/RESOLVEDPlaceboY08JAN202128JAN202112021-01-212021-01-211414
2A123A2008SKIN REDNESSSKIN REDNESSSkin Redness
16FEB202121FEB2021914
Y
YYYYNPROBABLY RELATEDRELATEDRELATEDMODERATEDOSE NOT CHANGEDDEVICE REPLACEDRECOVERED/RESOLVEDPlaceboY08FEB202101MAR202122021-02-162021-02-21914
3A123A3009INFLUENZAINFLUENZAInfluenzaInfections and infestations21JUN202126JUN20211318
YYY
YYYPROBABLY NOT RELATED
NOT RELATEDSEVERETRIAL INTERVENTION DISCONTINUED
RECOVERING/RESOLVINGPlaceboY09JUN202121JUN202132021-06-212021-06-261318
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ADAE Dataset Metadata

DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADAE

One record per subjectAnalysisSTUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT,
ADSL.SAS/SAP

ADXX Variable Metadata

Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study Identifiertext
ReqAE.STUDYID
USUBJIDUnique Subject Identifiertext
ReqAE.USUBJID
AETERMReported Term for the Adverse Eventtext
ReqAE.AETERM
AEMODIFYModified Reported Termtext
PermAE.MODIFY
AEBODSYSBody System or Organ Classtext
ReqAE.AEBODSYS
AEDECODDictionary-Derived Termtext
ReqAE.AEDECOD
ASTDTAnalysis Start Dateinteger
Cond

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

AENDTAnalysis End Dateinteger
Cond

Created from converting AE.AEENDTC from character ISO8601 format to numeric date 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-product FlagtextYCondIf ASTDT < ADSL.TRTSDT then PREFL=’Y’
TRTEMFLProductt Emergent Analysis FlagtextYCondIf ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’
FUPFLFollow-up FlagtextYCondIf ASTDT > ADSL.TRTEDT then FUPFL=’Y’

AETRTEMProduct 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
AERLDEVRelationship of Event to Devicetext

*

Perm

AE.AERLDEV

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 Producttext(ACN)PermAE.AEACN
AEACNDEVAction Taken with Device

text


PermAE.AEACNDEV
AEOUTOutcome of Adverse Eventtext(OUT)PermAE.AEOUT
TRTPPlanned Producttext
CondADSL.TRT01P
TRTAActual Treatmenttext
CondADSL.TRT01A
SAFFLSafety Population Flagtext
CondADSL.SAFFL
TRTSDTDate of First Exposure to Productinteger
PermADSL.TRTSDT
TRTEDTDate of Last Exposure to Productinteger
PermADSL.TRTEDT
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

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