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 will appear in a future version of the ADaM.
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adpp.xpt
Row
STUDYID
USUBJID
TRTA
AVISIT
PARQUAL
PARAM
PARAMCD
AVAL
PPSPEC
PPSEQ
PKFL
1
APP-123
123-0001
Drug A
Day 1
NICOTINE
AUC All (h*ng/mL)
AUCALL
11.4
PLASMA
3
Y
2
APP-123
123-0001
Drug A
Day 1
NICOTINE
Max Conc (ng/mL)
CMAX
13
PLASMA
2
Y
3
APP-123
123-0001
Drug A
Day 1
NICOTINE
Time of CMAX (h)
TMAX
5
PLASMA
1
Y
4
APP-123
123-0001
Drug A
Day 1
COTININE
Time of CMAX (h)
TMAX
6
PLASMA
5
Y
5
APP-123
123-0001
Drug A
Day 1
NNN
Time of CMAX (h)
TMAX
7
PLASMA
6
Y
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ADPP Dataset Metadata
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADPP
PP Analysis Data
Basic Data Structure
One record per subject per parameter per analysis visit
Analysis
STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT,
ADPP.xpt
ADPP.SAS/SAP
ADPP Variable Metadata
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)