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adex.xpt
| Row | STUDYID | USUBJID | ADT | ADY | EXTRT | DOSCUMA | EXSTDTC | EXENDTC | TRTA | EXDOSE | EXDOSU | SAFFL |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | A123 | A2001 | 8-Jan-21 | 1 | e-nicotine liquid | 6 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 2 | A123 | A2001 | 9-Jan-21 | 2 | e-nicotine liquid | 12 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 3 | A123 | A2001 | 10-Jan-21 | 3 | e-nicotine liquid | 18 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 4 | A123 | A2001 | 11-Jan-21 | 4 | e-nicotine liquid | 24 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 5 | A123 | A2001 | 12-Jan-21 | 5 | e-nicotine liquid | 30 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 6 | A123 | A2001 | 13-Jan-21 | 6 | e-nicotine liquid | 36 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 7 | A123 | A2001 | 14-Jan-21 | 7 | e-nicotine liquid | 42 | 021-01-08 | 2021-01-14 | Placebo | 6 | mL | Y |
| 8 | A123 | A2001 | 15-Jan-21 | 8 | e-nicotine liquid | 48.4 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 9 | A123 | A2001 | 16-Jan-21 | 9 | e-nicotine liquid | 54.8 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 10 | A123 | A2001 | 17-Jan-21 | 10 | e-nicotine liquid | 61.2 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 11 | A123 | A2001 | 18-Jan-21 | 11 | e-nicotine liquid | 67.6 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 12 | A123 | A2001 | 19-Jan-21 | 12 | e-nicotine liquid | 74 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 13 | A123 | A2001 | 20-Jan-21 | 13 | e-nicotine liquid | 80.4 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 14 | A123 | A2001 | 21-Jan-21 | 14 | e-nicotine liquid | 86.8 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y |
| 15 | A123 | A2001 | 22-Jan-21 | 15 | e-nicotine liquid | 93.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 16 | A123 | A2001 | 23-Jan-21 | 16 | e-nicotine liquid | 100.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 17 | A123 | A2001 | 24-Jan-21 | 17 | e-nicotine liquid | 107.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 18 | A123 | A2001 | 25-Jan-21 | 18 | e-nicotine liquid | 114.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 19 | A123 | A2001 | 26-Jan-21 | 19 | e-nicotine liquid | 121.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 20 | A123 | A2001 | 27-Jan-21 | 20 | e-nicotine liquid | 128.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 21 | A123 | A2001 | 28-Jan-21 | 21 | e-nicotine liquid | 135.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y |
| 22 | A123 | A2008 | 8-Feb-21 | 1 | e-nicotine liquid | 5 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 23 | A123 | A2008 | 9-Feb-21 | 2 | e-nicotine liquid | 10 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 24 | A123 | A2008 | 10-Feb-21 | 3 | e-nicotine liquid | 15 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 25 | A123 | A2008 | 11-Feb-21 | 4 | e-nicotine liquid | 20 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 26 | A123 | A2008 | 12-Feb-21 | 5 | e-nicotine liquid | 25 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 27 | A123 | A2008 | 13-Feb-21 | 6 | e-nicotine liquid | 30 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 28 | A123 | A2008 | 14-Feb-21 | 7 | e-nicotine liquid | 35 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y |
| 29 | A123 | A2008 | 15-Feb-21 | 8 | e-nicotine liquid | 42 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 30 | A123 | A2008 | 16-Feb-21 | 9 | e-nicotine liquid | 49 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 31 | A123 | A2008 | 17-Feb-21 | 10 | e-nicotine liquid | 56 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 32 | A123 | A2008 | 18-Feb-21 | 11 | e-nicotine liquid | 63 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 33 | A123 | A2008 | 19-Feb-21 | 12 | e-nicotine liquid | 70 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 34 | A123 | A2008 | 20-Feb-21 | 13 | e-nicotine liquid | 77 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 35 | A123 | A2008 | 21-Feb-21 | 14 | e-nicotine liquid | 84 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y |
| 36 | A123 | A2008 | 22-Feb-21 | 15 | e-nicotine liquid | 92 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 37 | A123 | A2008 | 23-Feb-21 | 16 | e-nicotine liquid | 100 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 38 | A123 | A2008 | 24-Feb-21 | 17 | e-nicotine liquid | 108 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 39 | A123 | A2008 | 25-Feb-21 | 18 | e-nicotine liquid | 116 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 40 | A123 | A2008 | 26-Feb-21 | 19 | e-nicotine liquid | 124 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 41 | A123 | A2008 | 27-Feb-21 | 20 | e-nicotine liquid | 132 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 42 | A123 | A2008 | 28-Feb-21 | 21 | e-nicotine liquid | 140 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 43 | A123 | A2008 | 1-Mar-21 | 22 | e-nicotine liquid | 148 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y |
| 44 | A123 | A3009 | 9-Jun-21 | 1 | e-nicotine liquid | 8 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 45 | A123 | A3009 | 10-Jun-21 | 2 | e-nicotine liquid | 16 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 46 | A123 | A3009 | 11-Jun-21 | 3 | e-nicotine liquid | 24 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 47 | A123 | A3009 | 12-Jun-21 | 4 | e-nicotine liquid | 32 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 48 | A123 | A3009 | 13-Jun-21 | 5 | e-nicotine liquid | 40 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 49 | A123 | A3009 | 14-Jun-21 | 6 | e-nicotine liquid | 48 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 50 | A123 | A3009 | 15-Jun-21 | 7 | e-nicotine liquid | 56 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y |
| 51 | A123 | A3009 | 16-Jun-21 | 8 | e-nicotine liquid | 62.7 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
| 52 | A123 | A3009 | 17-Jun-21 | 9 | e-nicotine liquid | 69.4 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
| 53 | A123 | A3009 | 18-Jun-21 | 10 | e-nicotine liquid | 76.1 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
| 54 | A123 | A3009 | 19-Jun-21 | 11 | e-nicotine liquid | 82.8 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
| 55 | A123 | A3009 | 20-Jun-21 | 12 | e-nicotine liquid | 89.5 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
| 56 | A123 | A3009 | 21-Jun-21 | 13 | e-nicotine liquid | 96.2 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
ADXX Variable Metadata
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
| STUDYID | Study Identifier | text | Req | EX.STUDYID | |
| USUBJID | Unique Subject Identifier | text | Req | EX.USUBJID | |
| ADT | Analysis Start Date | integer | Perm | create a value for every date from EX.EXSTDTC to EX.EXENDTC | |
| ADY | Analysis Start Relative Day | integer | Perm | ADT.TRTSDT+1 | |
| EXTRT | Name of Treatment | text | Req | EX.EXTRT | |
| DOSCUMA | Cumulative Actual Treatment Dose | float | Perm | Cumulative dose within USUBJID | |
| EXSTDTC | Start Date/Time of Treatment | text | Perm | EX.EXSTDTC | |
| EXENDTC | End Date/Time of Treatment | text | Perm | EX.EXENDTC | |
| TRTA | Actual Treatment | text | Cond | ADSL.TRT01A | |
| EXDOSE | Dose | float | Perm | EX.EXDOSE | |
| EXDOSU | Dose Units | text | Perm | EX.EXDOSU | |
| SAFFL | Safety Population Flag | text | Cond | ADSL.SAFFL |
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adexsum.xpt
| Row | STUDYID | USUBJID | TRTA | PARAM | PARAMCD | PARAMN | AVAL | SAFFL |
|---|---|---|---|---|---|---|---|---|
| 1 | A123 | A2001 | Placebo | Number of Doses | NDOSES | 1 | 21 | Y |
| 2 | A123 | A2001 | Placebo | Average Daily Dose | ADD | 2 | 6.466667 | Y |
| 3 | A123 | A2001 | Placebo | Total Dose | TOTDOSE | 3 | 135.8 | Y |
| 4 | A123 | A2008 | Product A | Number of Doses | NDOSES | 1 | 22 | Y |
| 5 | A123 | A2008 | Product A | Average Daily Dose | ADD | 2 | 6.727273 | Y |
| 6 | A123 | A2008 | Product A | Total Dose | TOTDOSE | 3 | 148 | Y |
| 7 | A123 | A3009 | Product B | Number of Doses | NDOSES | 1 | 13 | Y |
| 8 | A123 | A3009 | Product B | Average Daily Dose | ADD | 2 | 7.4 | Y |
| 9 | A123 | A3009 | Product B | Total Dose | TOTDOSE | 3 | 96.2 | Y |
ADXX Variable Metadata
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | Char | Req | ADEX.STUDYID | |
| USUBJID | Unique Subject Identifier | Char | Req | ADEX.USUBJID | |
| TRTA | Actual Treatment | Char | Cond | ADEX.TRT01A | |
| PARAM | Parameter | Char | Req | Assigned | |
| PARAMCD | Parameter Code | text | Req | Assigned | |
| PARAMN | Parameter (N) | Num | Perm | Assigned | |
| AVAL | Analysis Value | Num | Cond | see parameter level metadata | |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
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