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This is an example of an ADaM dataset designed to describe the main variables needed to perform  a PK Parameter summary. The dataset decribed below is called ADPP and is based on the SDTM PP domain. Values from ADSL and PP are combined to capture observations that can be summarized. This is just an example and does not mean to indicate that ADPP must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study. One item to note is the use of PARQUAL which is not yet included in any ADaMIG but will appear in a future version of the ADaM.


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
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

CMAX. TMAX, AUC

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