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This is an example of an ADaM dataset designed to describe the main variables needed to perform a PK Parameter summary. The dataset decribed below is called ADPP and is based on the SDTM PP domain. 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 is not yet included in any ADaMIG but will appear in a future version of the ADaM.
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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 | 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 |
| STUDYID | USUBJID | TRTA | AVISIT | PARQUAL | PARAM | PARAMCD | AVAL | PPSPEC | PPSEQ | PKFL |
|---|---|---|---|---|---|---|---|---|---|---|
| ABC-123 | 123-0001 | Drug A | Day 1 | NICOTINE | AUC All (h*ng/mL) | AUCALL | 11.4 | PLASMA | 3 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NICOTINE | Nicotine - Max Conc (ng/mL) | CMAX | 9 | PLASMA | 2 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NICOTINE | Nicotine - Time of CMAX (h) | TMAX | 5 | PLASMA | 1 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | COTININE | Time of CMAX (h) | TMAX | 6 | PLASMA | 5 | Y |
| ABC-123 | 123-0001 | Drug A | Day 1 | NNN | Time of CMAX (h) | TMAX | 7 | PLASMA | 6 | Y |
CMAX. TMAX, AUC
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