| Dataset2 |
|---|
| Row | STUDYID | USUBJID | TRTA | AVISIT | PARQUAL | PARAM | PARAMCD | AVAL | PPSPEC | PPSEQ | PKFL |
|---|
| 1 | APP-123 | 123-0001 | Drug Product A | Day 1 | NICOTINE | AUC All (h*ng/mL) | AUCALL | 11.4 | PLASMA | 3 | Y | | 2 | APP-123 | 123-0001 | Drug Product A | Day 1 | NICOTINE | Max Conc (ng/mL) | CMAX | 13 | PLASMA | 2 | Y | | 3 | APP-123 | 123-0001 | Drug Product A | Day 1 | NICOTINE | Time of CMAX (h) | TMAX | 5 | PLASMA | 1 | Y | | 4 | APP-123 | 123-0001 | Drug Product A | Day 1 | COTININE | Time of CMAX (h) | TMAX | 6 | PLASMA | 5 | Y | | 5 | APP-123 | 123-0001 | Drug Product A | Day 1 | NNN | Time of CMAX (h) | TMAX | 7 | PLASMA | 6 | Y |
|
| Definexmltable |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
| Name | ADPP |
|---|
| | 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 | |
| Definexmltable |
|---|
| Dataset | ADPP |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
| 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 TreatmentProduct | text | Drug Product 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 |
|
|