Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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 those that would be used in a particular study. One item to note is the use of PARQUAL, which will appear in a future version of the ADaM. 

...

Variable
Name

...

Variable Label

...

Codelist/
Controlled
Terms

...

Dataset wrap
NameADPP
Dataset2
RowSTUDYIDUSUBJIDTRTAAVISITPARQUALPARAMPARAMCDAVALPPSPECPPSEQPKFL
1A123A2008Product ADay 1NICOTINE
AUC All (h*ng/mL)

...

AUCALL11.4PLASMA3Y
2A123A2008Product ADay 1NICOTINEMax Conc (ng/mL)

...

CMAX13PLASMA2Y
3A123A2008Product ADay 1NICOTINETime of CMAX (h)

...

TMAX5PLASMA1Y
4A123A2008Product ADay 1COTININETime of CMAX (h)TMAX6PLASMA5Y
5A123A2008Product ADay 1NNN

...

Time of CMAX (h)

...

TMAX7PLASMA6Y
Definexmltable
LevelDataset
PurposeAnalysis
NameADPP
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADPPPP Analysis DataBasic Data StructureOne record per subject per parameter per analysis visitAnalysisSTUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT,ADPP.xptADPP.SAS/SAP

...

Definexmltable
DatasetADPP
LevelVariable
PurposeAnalysis

Variable Name

Variable LabelType

Codelist/Controlled Terms

Core

Notes
STUDYIDStudy IdentifiertextABC-123ReqADSL.STUDYID
USUBJIDUnique Subject Identifiertext
ReqPP.STUDYID
TRTAActual ProducttextProduct ACondADSL.TRT01A
AVISITAnalysis VisittextDay 1CondSet to propcase of PP.VISIT
PARQUALParameter Qualifiertext

NICOTINE 
COTININE
NNN

Perm

PP.PPCAT
PARAMParametertext
AUC All (h*ng/mL)

...


...

Max Conc (ng/mL)

...

Time of CMAX (h)ReqAssigned
PARAMCDParameter CodetextAUCALL
CMAX
TMAX
ReqAssigned
AVALAnalysis Valuefloat
ReqPP.PPSTRESN
PPSPECSpecimen Material TypetextPLASMAPermPP.PPSPEC
PPSEQSequence Numbertext
PermPP.PPSEQ
PKFLPK Population FlagtextY;NCondADSL.PKFL

...