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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 |
| PARQUAL | Parameter Qualifier | text | NICOTINE COTININE NNN | PP.PPCAT |
| 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 | AUCALLNIAUCALL NICMAXCMAX NITMAXTMAXCOTMAX NNTMAX | 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 |
| STUDYID | USUBJID | TRTA | AVISIT | PARQUAL | PARAM | PARAMCD | AVAL | PPSPEC | PPSEQ | PKFL |
|---|---|---|---|---|---|---|---|---|---|---|
| ABC-123 | 123-0001 | Drug A | Day 1 | NICOTINE | Nicotine - AUC All (h*ng/mL) | NIAUCALLAUCALL | 11.4 | PLASMA | 3 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NICOTINE | Nicotine - Max Conc (ng/mL) | NICMAXCMAX | 9 | PLASMA | 2 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NICOTINE | Nicotine - Time of CMAX (h) | NITMAXTMAX | 5 | PLASMA | 1 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | COTININE | Cotinine - Time of CMAX (h) | COTMAXTMAX | 6 | PLASMA | 5 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NNN | - Time of CMAX (h) | NNTMAXTMAX | 7 | PLASMA | 6 | Y |
CMAX. TMAX, AUC
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