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changes.mady.by.user Kathleen Mellars

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changes.mady.by.user Alana St. Clair

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Dataset wrap
Nameadae
Dataset2
tableidadae

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
Definexmltable
LevelDataset
PurposeAnalysis
NameADAE
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADAEAdverse Events Analysis DatasetOCCURRENCE DATA STRUCTUREOne record per subject per adverse eventAnalysisSTUDYID, USUBJID,
PARQUAL
AEBODSYS,
PARAMCD, AVISIT,
AEDECOD, AETERMADAE.xptADAE
ADSL
.SAS/SAP
Definexmltable
DatasetADAE
LevelVariable
PurposeAnalysis
OIDADAE
NameADAE
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study Identifiertext
ReqAE.STUDYID
USUBJIDUnique Subject Identifiertext
ReqAE.USUBJID
AETERMReported Term for the Adverse Experiencetext
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’
TRTEMFL
Productt

Product

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-787
Emergent Analysis Flag

textYCondIf 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 product emergent record for each subject.
AOCCPFL1st Occurrence of Preferred Term FlagtextYPermSort the data in the required order and flag the first product emergent record for each AEDECOD for each subject.
AOCCSFL1st Occurrence of SOC FlagtextYPerm Sort the data in the required order and flag the first product emergent record for each body system for each subject.
AESER

Serious

Event

Experience

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-788

text(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
TPACN)PermAE.AEACN
AEACNDEVAction Taken with Device

text


PermAE.AEACNDEV
AEOUTOutcome of Adverse
Event
Experiencetext(OUT)PermAE.AEOUT
TRTAActual Producttext
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
Event
experiencetext
PermAE.AEOUT
AESEQSequence Numberinteger
PermAE.AESEQ
AESTDTCStart Date/Time of
Adverse
Event
Experience

text


PermAE.AESTDTC
AEENDTCEnd Date/Time of
Adverse
Event
Experiencetext
PermAE.AEENDTC
AESTDY

Study Day of Start of
Adverse

Event

Experience

text
PermAE.AESTDY
AEENDYStudy Day of End of
Adverse
Event
Experiencetext
PermAE.AEENDY
AEENRFEnd Relative to
Reference Period		text
PermAE.AEENRF