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Dataset wrap
Nameadex
Dataset2
tableidadex
RowSTUDYIDUSUBJIDASTDTASTDYAENDTAENDYEXTRTDOSCUMAEXSTDTCEXENDTCTRTAEXDOSEEXDOSUSAFFL
1A123A200108JAN2021

1

14JAN2021

7

e-nicotine liquid

6

021-01-082021-01-14Placebo6mLY
2A123A2001

15JAN2021

8

21JAN2021

14e-nicotine liquid12.42021-01-152021-01-21Placebo6.4mLY
3A123A2001

22JAN2021

15

28JAN2021

21e-nicotine liquid19.42021-01-222021-01-28Placebo7mLY
4A123A2008

08FEB2021

1

14FEB2021

7

e-nicotine liquid52021-02-082021-02-14Product A5mLY
5A123A200815FEB2021821FEB202114e-nicotine liquid122021-02-152021-02-21Product A7mLY
6A123A200822FEB20211501MAR202122e-nicotine liquid202021-02-222021-03-01Product A8mLY
7A123A300909JUN2021

1

15JUN2021

7

e-nicotine liquid82021-06-092021-06-15Product B8mLY
8A123A300916JUN2021821JUN202113e-nicotine liquid14.72021-06-162021-06-21Product B6.7mLY
Definexmltable
DatasetADEX
LevelDataset
PurposeAnalysis
NameADEX
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADEXExposure Analysis DatasetOCCURRENCE DATA STRUCTUREOne record per subject per treatment (EXTRT) per start dateAnalysisSTUDYID, USUBJID, EXTRT, ASTDTADEX.xptADEX.SAS/SAP
Definexmltable
DatasetADEX
LevelVariable
PurposeAnalysis
NameADEX

Variable Name

Variable LabelTypeCodelist/Controlled TermsCoreCDISC Notes
STUDYIDStudy Identifiertext
ReqEX.STUDYID
USUBJIDUnique Subject Identifiertext
ReqEX.USUBJID
ASTDTAnalysis Start Date

integer


Perm

EX.EXSTDTC cpatured as a numeric variable

ASTDYAnalysis Start Relative Dayinteger
PermASTDT-ADT.TRTSDT+1
AENDTAnalysis End Dateinteger
PermEX.EXENDTC cpatured as a numeric variable
AENDYAnalysis End Relative Dayinteger
PermAENDT-ADT.TRTSDT+1
EXTRTName of Producttext
ReqEX.EXTRT
DOSCUMA

Cumulative Actual Product Dose

float
PermCumulative dose within USUBJID
EXSTDTCStart Date/Time of Producttext
PermEX.EXSTDTC
EXENDTCEnd Date/Time of Producttext
PermEX.EXENDTC
TRTAActual Producttext
CondADSL.TRT01A
EXDOSEDosefloat
PermEX.EXDOSE
EXDOSUDose Unitstext
PermEX.EXDOSU
SAFFL

Safety Population Flag

text
CondADSL.SAFFL

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