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Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study Identifiertext
ReqAE.STUDYID
USUBJIDUnique Subject Identifiertext
ReqAE.USUBJID
ASTDTAnalysis Start DateintegerCond

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

ASTDTMAnalysis Start Date/TimeintegerCondCreated from converting AE.AESTDTC from character ISO8601 format to numeric datetime format
AETERMReported Term for the Adverse Eventtext
ReqAE.AETERM
AEBODSYSBody System or Organ Classtext
ReqAE.AEBODSYS
AEDECODDictionary-Derived Termtext
ReqAE.AEDECOD
ASTDTAnalysis Start
AENDTAnalysis End
Dateinteger
Cond

Created from converting AE.

AEENDTC

AESTDTC from character ISO8601 format to numeric date format

AENDTM
AENDTAnalysis End Date
/Time
integer
Cond

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

datetime

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-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
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 Treatmenttext(ACN)PermAE.AEACN
AEACNDEVAction Taken with Device

text


PermAE.AEACNDEV
AEOUTOutcome of Adverse Eventtext(OUT)PermAE.AEOUT
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 EventtextReqAE.AETERMAEBODSYSBody System or Organ ClasstextReqAE.AEBODSYSAEDECODDictionary-Derived TermtextReqAE.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

USUBJIDAETERM
ASTDTASTDTM
AEMODIFYAEDECODAEBODSYSASTDTAENDT
AENDTM
ASTDYAENDYPREFLTRTEMFLFUPFLAETRTEMAOCCFLAOCCPFLAOCCSFLAESERAERELAERLDEVRELGR1AESEVAEACNAEACNDEVAEOUTTRTASAFFLTRTSDTTRTEDT
AETERMAEBODSYSAEDECOD
AEOUTAESEQAESTDTCAEENDTCAESTDYAEENDYAEENRF
ABC12312310112OCT200512OCT2005-1
A123A2001POUNDING HEADACHEHEADACHEHeadacheNervous system disorders21JAN202121JAN20211616
-1
Y





NDEFINITELY NOT RELATED
NOT RELATEDSEVEREDOSE NOT
APPLICABLE
CHANGED
RECOVERED/RESOLVEDProduct AY
13OCT200520OCT2005POUNDING HEADACHENervous system disordersHeadache
17DEC202004JAN2021RECOVERED/RESOLVED1
2005
2021-
10
01-
12
21
2005
2021-
10
01-
12-1-1ABC12312310113OCT200513OCT2005:13:0513OCT200513OCT2005:19:001
211616
A123A2008SKIN REDNESSSKIN REDNESSSkin Redness
16FEB202121FEB2021813
1

Y
YYYYNPROBABLY RELATED
Product A
RELATEDRELATEDMODERATEDOSE
REDUCED
NOT CHANGEDDEVICE REPLACEDRECOVERED/RESOLVEDProduct AY
13OCT200520OCT2005BACK PAIN FOR 6 HOURSMusculoskeletal and connective tissue disordersBack pain
09FEB202127FEB2021RECOVERED/RESOLVED2
2005
2021-
10
02-
13T13:05
16
2005
2021-
10-13T19:0011ABC12312310121OCT20059
02-21813
A123A3009INFLUENZAINFLUENZAInfluenzaInfections and infestations21JUN202126JUN20211318
YYY
YYYPROBABLY NOT RELATED
NOT RELATEDSEVERE
MODERATE
TRIAL INTERVENTION DISCONTINUED
RECOVERING/RESOLVING
DOSE REDUCED
Product AY
13OCT2005
09JUN2021
20OCT2005PULMONARY EMBOLISMVascular disordersPulmonary embolism
26JUN2021RECOVERING/RESOLVING3
2005
2021-
10
06-21
9AFTER
2021-06-261318