Page History
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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 | EXSEQ | integer | EX.EXSEQ |
ADEX dataset
STUDYID | USUBJID | ADT | ADY | EXTRT | DOSCUMA | EXSTDTC | EXENDTC | TRTP | EXTRTTRTA | EXDOSE | EXDOSU | SAFFLEXSEQ | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
A123 | A2001 | 8-Jan-21 | 1 | e-nicotine liquid | 6 | 021-01-08 | 2021-01-14 | Product A | e-nicotine liquidPlacebo | 6 | mL | Y1 | |
A123 | A2001 | 9-Jan-21 | 2 | e-nicotine liquid | 12 | 021-01-08 | 2021-01-14 | Product A | Placebo | 6e-nicotine liquid | mL | Y | 2 |
A123 | A2001 | 10-Jan-21 | 3 | e-nicotine liquid | 18 | 021-01-08 | 2021-01-14 | Product A | Placebo | 6e-nicotine liquid | mL | Y3 | |
A123 | A2001 | 11-Jan-21 | 4 | e-nicotine liquid | 24 | 021-01-08 | 2021-01-14 | Product A | Placebo | 6e-nicotine liquid | mL | Y4 | |
A123 | A2001 | 12-Jan-21 | 5 | e-nicotine liquid | 30 | 021-01-08 | 2021-01-14 | Product B | Placebo | 6e-nicotine liquid | mL | Y1 | |
A123 | A2001 | 13-Jan-21 | 6 | e-nicotine liquid | 36 | 021-01-08 | 2021-01-14 | Product B | Placebo | 6e-nicotine liquid | mL | Y | 2 |
A123 | A2001 | 14-Jan-21 | 7 | e-nicotine liquid | 42 | 021-01-08 | 2021-01-14 | Product B | Placebo | 6e-nicotine liquid | mL | Y3 | |
A123 | A2001 | 15-Jan-21 | 8 | e-nicotine liquid | 48.4 | 2021-01-15 | 2021-01-21 | Product B | e-nicotine liquidPlacebo | 6.4 | mL | Y4 | |
A123 | A2001 | 16-Jan-21 | 9 | e-nicotine liquid | 54.8 | 2021-01-15 | 2021-01-21 | Product B | Placebo | 6.4e-nicotine liquid | mL | Y | 5 |
A123 | A2001 | 17-Jan-21 | 10 | e-nicotine liquid | 61.2 | 2021-01-15 | 2021-01-21 | Product B | Placebo | 6.4e-nicotine liquid | mL | Y6 | |
A123 | A2001 | 18-Jan-21 | 11 | e-nicotine liquid | 67.6 | 2021-01-15 | 2021-01-21 | Product B | Placebo | 6.4e-nicotine liquid | mL | Y | 7 |
A123 | A2001 | 19-Jan-21 | 12 | e-nicotine liquid | 74 | 2021-01-15 | 2021-01-21 | Product B | Placebo | 6.4e-nicotine liquid | mL | Y8 | |
A123 | A2001 | 20-Jan-21 | 13 | e-nicotine liquid | 80.4 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | ||
A123 | A2001 | 21-Jan-21 | 14 | e-nicotine liquid | 86.8 | 2021-01-15 | 2021-01-21 | Placebo | 6.4 | mL | Y | ||
A123 | A2001 | 22-Jan-21 | 15 | e-nicotine liquid | 93.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2001 | 23-Jan-21 | 16 | e-nicotine liquid | 100.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2001 | 24-Jan-21 | 17 | e-nicotine liquid | 107.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2001 | 25-Jan-21 | 18 | e-nicotine liquid | 114.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2001 | 26-Jan-21 | 19 | e-nicotine liquid | 121.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2001 | 27-Jan-21 | 20 | e-nicotine liquid | 128.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2001 | 28-Jan-21 | 21 | e-nicotine liquid | 135.8 | 2021-01-22 | 2021-01-28 | Placebo | 7 | mL | Y | ||
A123 | A2008 | 8-Feb-21 | 1 | e-nicotine liquid | 5 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 9-Feb-21 | 2 | e-nicotine liquid | 10 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 10-Feb-21 | 3 | e-nicotine liquid | 15 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 11-Feb-21 | 4 | e-nicotine liquid | 20 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 12-Feb-21 | 5 | e-nicotine liquid | 25 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 13-Feb-21 | 6 | e-nicotine liquid | 30 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 14-Feb-21 | 7 | e-nicotine liquid | 35 | 2021-02-08 | 2021-02-14 | Product A | 5 | mL | Y | ||
A123 | A2008 | 15-Feb-21 | 8 | e-nicotine liquid | 42 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 16-Feb-21 | 9 | e-nicotine liquid | 49 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 17-Feb-21 | 10 | e-nicotine liquid | 56 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 18-Feb-21 | 11 | e-nicotine liquid | 63 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 19-Feb-21 | 12 | e-nicotine liquid | 70 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 20-Feb-21 | 13 | e-nicotine liquid | 77 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 21-Feb-21 | 14 | e-nicotine liquid | 84 | 2021-02-15 | 2021-02-21 | Product A | 7 | mL | Y | ||
A123 | A2008 | 22-Feb-21 | 15 | e-nicotine liquid | 92 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 23-Feb-21 | 16 | e-nicotine liquid | 100 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 24-Feb-21 | 17 | e-nicotine liquid | 108 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 25-Feb-21 | 18 | e-nicotine liquid | 116 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 26-Feb-21 | 19 | e-nicotine liquid | 124 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 27-Feb-21 | 20 | e-nicotine liquid | 132 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 28-Feb-21 | 21 | e-nicotine liquid | 140 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A2008 | 1-Mar-21 | 22 | e-nicotine liquid | 148 | 2021-02-22 | 2021-03-01 | Product A | 8 | mL | Y | ||
A123 | A3009 | 9-Jun-21 | 1 | e-nicotine liquid | 8 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 10-Jun-21 | 2 | e-nicotine liquid | 16 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 11-Jun-21 | 3 | e-nicotine liquid | 24 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 12-Jun-21 | 4 | e-nicotine liquid | 32 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 13-Jun-21 | 5 | e-nicotine liquid | 40 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 14-Jun-21 | 6 | e-nicotine liquid | 48 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 15-Jun-21 | 7 | e-nicotine liquid | 56 | 2021-06-09 | 2021-06-15 | Product B | 8 | mL | Y | ||
A123 | A3009 | 16-Jun-21 | 8 | e-nicotine liquid | 62.7 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | ||
A123 | A3009 | 17-Jun-21 | 9 | e-nicotine liquid | 69.4 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | ||
A123 | A3009 | 18-Jun-21 | 10 | e-nicotine liquid | 76.1 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | ||
A123 | A3009 | 19-Jun-21 | 11 | e-nicotine liquid | 82.8 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | ||
A123 | A3009 | 20-Jun-21 | 12 | e-nicotine liquid | 89.5 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y | ||
A123 | A3009 | 21-Jun-21 | 13 | e-nicotine liquid | 96.2 | 2021-06-16 | 2021-06-21 | Product B | 6.7 | mL | Y |
ADEXSUM metadtaa
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 | TRTP | Planned Treatment | Char | Cond | ADEX.TRT01P | TRT01P | Planned Treatment for Period 01 | Char|||||||||||||||||||
Cond | ADEX.TRT01P | TRTA | Actual Treatment | Char | Cond | ADEX.TRT01ATRT01A | Actual Treatment for Period 01Char | 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 | COUNTRY | Country | Char | Perm | ADSL.COUNTRY | AGE | Age | Num | Perm | ADSL.AGE | SEX | Sex | Char | Perm | ADSL.SEX | RACE | Race | Char | Perm | ADSL.RACE | ETHNIC | Ethnicity | Char | Perm | ADSL.ETHNIC | |
SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL | TRTSDT | Date of First Exposure to Treatment | Num | Perm | ADSL.TRTSDT | TRTEDT | Date of Last Exposure to Treatment | Num | Perm | ADSL.TRTEDT |
ADEXSUM data
STUDYID | USUBJID | TRTP | TRT01P | TRTATRT01A | PARAM | PARAMCD | PARAMN | AVAL | SAFFL |
---|---|---|---|---|---|---|---|---|---|
A123 | A2001 | Placebo | Number of Doses | NDOSES | 1 | 21 | Y | ||
A123 | A2001 | Placebo | Average Daily Dose | ADD | 2 | 6.466667 | Y | ||
A123 | A2001 | Placebo | Total Dose | TOTDOSE | 3 | 135.8 | Y | ||
A123 | A2008 | Product A | Number of Doses | NDOSES | 1 | 22 | Y | ||
A123 | A2008 | Product A | Average Daily Dose | ADD | 2 | 6.727273 | Y | ||
A123 | A2008 | Product A | Total Dose | TOTDOSE | 3 | 148 | Y | ||
A123 | A3009 | Product B | Number of Doses | NDOSES | 1 | 13 | Y | ||
A123 | A3009 | Product B | Average Daily Dose | ADD | 2 | 7.4 | Y | ||
A123 | A3009 | Product B | Total Dose | TOTDOSE | 3 | 96.2 | Y |
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