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Definexmltable
ExtraNotes
DatasetADPP
Exampletrue
LevelVariable
PurposeAnalysis

Variable
Name

Variable Label

Type

Codelist/
Controlled
Terms

Notes
STUDYIDStudy IdentifiertextABC-123ADSL.STUDYID
USUBJIDUnique Subject Identifiertext
PP.STUDYID
TRTAActual TreatmenttextDrug AADSL.TRT01A
AVISITAnalysis VisittextDay 1Set to propcase of PP.VISIT
PARQUALParameter Qualifiertext

NICOTINE

COTININE

NNN

PP.PPCAT
PARAMParametertextAUC All (h*ng/mL)
Max Conc (ng/mL)
Time of CMAX (h)
Assigned
PARAMCDParameter CodetextAUCALL
CMAX
TMAX
Assigned
AVAL Analysis Valuefloat
PP.PPSTRESN
PPSPECSpecimen Material TypetextPLASMAPP.PPSPEC
PPSEQ  Sequence Numbertext
PP.PPSEQ
PKFLPK Population FlagtextY;NADSL.PKFL
Dataset2
STUDYIDUSUBJIDTRTA AVISITPARQUALPARAM  PARAMCDAVAL  PPSPECPPSEQ  PKFL
ABC-123123-0001Drug ADay 1NICOTINEAUC All (h*ng/mL)AUCALL11.4PLASMA3Y
ABC-123123-0001Drug ADay 1NICOTINENicotine - Max Conc (ng/mL)CMAX9PLASMA2Y
ABC-123123-0001Drug ADay 1NICOTINENicotine - Time of CMAX (h)TMAX5PLASMA1Y
ABC-123123-0001Drug ADay 1COTININETime of CMAX (h)TMAX6PLASMA5Y
ABC-123123-0001Drug ADay 1NNNTime of CMAX (h)TMAX7PLASMA6Y



Variable
Name

Variable Label

Type

Codelist/
Controlled
Terms

Notes
STUDYIDStudy IdentifiertextABC-123ADSL.STUDYID
USUBJIDUnique Subject Identifiertext
PP.STUDYID
TRTAActual TreatmenttextDrug AADSL.TRT01A
AVISITAnalysis VisittextDay 1Set to propcase of PP.VISIT
PARQUALParameter Qualifiertext

NICOTINE

COTININE

NNN

PP.PPCAT
PARAMParametertextAUC All (h*ng/mL)
Max Conc (ng/mL)
Time of CMAX (h)
Assigned
PARAMCDParameter CodetextAUCALL
CMAX
TMAX
Assigned
AVAL Analysis Valuefloat
PP.PPSTRESN
PPSPECSpecimen Material TypetextPLASMAPP.PPSPEC
PPSEQ  Sequence Numbertext
PP.PPSEQ
PKFLPK Population FlagtextY;NADSL.PKFL

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