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Dataset wrap

Name	ADPP

Dataset2

STUDYID	USUBJID	TRTA	AVISIT	PARQUAL	PARAM	PARAMCD	AVAL	PPSPEC	PPSEQ	PKFL
APP-123	123-0001	Drug A	Day 1	NICOTINE	AUC All (h*ng/mL)	AUCALL	11.4	PLASMA	3	Y
APP-123	123-0001	Drug A	Day 1	NICOTINE	Nicotine - Max Conc (ng/mL)	CMAX	13	PLASMA	2	Y
APP-123	123-0001	Drug A	Day 1	NICOTINE	Nicotine - Time of CMAX (h)	TMAX	5	PLASMA	1	Y
APP-123	123-0001	Drug A	Day 1	COTININE	Time of CMAX (h)	TMAX	6	PLASMA	5	Y
APP-123	123-0001	Drug A	Day 1	NNN	Time of CMAX (h)	TMAX	7	PLASMA	6	Y

Definexmltable

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADPP	PP Analysis Data	Basic Data Structure	One record per subject per parameter per analysis visit and day	Analysis	STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT,	ADPP.xpt	ADPP.SAS/SAP

Definexmltable

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Notes
STUDYID	Study Identifier	text	ABC-123	ADSL.STUDYID
USUBJID	Unique Subject Identifier	text		PP.STUDYID
TRTA	Actual Treatment	text	Drug A	ADSL.TRT01A
AVISIT	Analysis Visit	text	Day 1	Set to propcase of PP.VISIT
PARQUAL	Parameter Qualifier	text	NICOTINE COTININE NNN	PP.PPCAT
PARAM	Parameter	text	AUC All (h*ng/mL) Max Conc (ng/mL) Time of CMAX (h)	Assigned
PARAMCD	Parameter Code	text	AUCALL CMAX TMAX	Assigned
AVAL	Analysis Value	float		PP.PPSTRESN
PPSPEC	Specimen Material Type	text	PLASMA	PP.PPSPEC
PPSEQ	Sequence Number	text		PP.PPSEQ
PKFL	PK Population Flag	text	Y;N	ADSL.PKFL

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