Variable | Variable Label | Type | Codelist/ | 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 |
| PARAM | Parameter | text | Nicotine - AUC All (h*ng/mL) Nicotine - Max Conc (ng/mL) Nicotine - Time of CMAX (h) Cotinine - Time of CMAX (h) NNN - Time of CMAX (h) | Assigned |
| PARAMCD | Parameter Code | text | NIAUCALL NICMAX NITMAX COTMAX NNTMAX | Assigned |
| AVAL | Analysis Value | 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 |
| STUDYID | USUBJID | TRTA | AVISIT | PARAM | PARAMCD | AVAL | PPSPEC | PPSEQ | PKFL |
|---|---|---|---|---|---|---|---|---|---|
| ABC-123 | 123-0001 | Drug A | Day 1 | Nicotine - AUC All (h*ng/mL) | NIAUCALL | 11.4 | PLASMA | 3 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | Nicotine - Max Conc (ng/mL) | NICMAX | 9 | PLASMA | 2 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | Nicotine - Time of CMAX (h) | NITMAX | 5 | PLASMA | 1 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | Cotinine - Time of CMAX (h) | COTMAX | 6 | PLASMA | 5 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NNN - Time of CMAX (h) | NNTMAX | 7 | PLASMA | 6 | Y |
CMAX. TMAX, AUC
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