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Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes | |||||
| STUDYID | Study Identifier | text | EX.STUDYID | |||||||
| USUBJID | Unique Subject Identifier | text | EX.USUBJID | |||||||
| ASTDTADT | Analysis Start Date | integer | numeric SAS date variable based on EXSTDTC with no imputation for partial dates | AENDT | Analysis End Date | integer | numeric SAS date variable based on EXENDTC with no imputation for partial dates | create a value for every date from EX.EXSTDTC to EX.EXENDTC | ||
| ADYASTDY | Analysis Start Relative Day | integer | ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT | AENDY | Analysis End Relative Day | integer | AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT | ADT.TRTSDT+1 | ||
| EXTRT | text | EX.EXTRT | ||||||||
| EXSTDTC | text | EX.EXSTDTC | ||||||||
| EXENDTC | text | EX.EXENDTC | ||||||||
| TRTPTRTA | text | ADSL.TRT01PTRT01A | ||||||||
| EXTRT | text | EX.EXTRT | EXDOSE | EX.EXDOSE | ||||||
| EXDOSU | text | EX.EXDOSU | ||||||||
| SAFFL | text | ADSL.SAFFL | ||||||||
| EXSEQ | integer | EX.EXSEQ |
ADEX dataset
| STUDYID | USUBJID | ASTDTADT | AENDTADY | ASTDYDOSCUMA | AENDY | EXSTDTC | EXENDTC | TRTP | EXTRT | EXDOSE | EXDOSU | SAFFL | EXSEQ | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TENDS01A123 | TEN01001A2001 | 20208-06-26 | 2020-07-01Jan-21 | 1 | 6 | 021-01-08 | 2021-01-14 | Product A | e-nicotine liquid | 6 | mL | Y | 1 | ||||||||||||||
| TENDS01A123 | TEN01001A20012020-07 | 9-Jan-21 | 2 | 12 | 021-01-08 | 20202021- | 0701- | 0614 | Product A | e-nicotine liquid6.4 | mL | Y | 2 | TENDS01 | TEN01001 | 2020-07-06 | 2020-07-10|||||||||||
| A123 | A2001 | 10-Jan-21 | 3 | 18 | 021-01-08 | 2021-01-14 | Product A | e-nicotine liquid | 7 | mL | Y | 3 | TENDS01 | TEN01001 | 2020-07-10 | 2020-07||||||||||||
| A123 | A2001 | 11-Jan-21 | 4 | 24 | 021-01-08 | 2021-01-14 | Product A | e-nicotine liquid | 8 | mL | Y | 4 | |||||||||||||||
| TENDS01A123 | TEN10002A20012020-09 | 12-Jan-21 | 5 | 30 | 021-01-08 | 20202021- | 0901- | 0714 | Product B | e-nicotine liquid | 5 | mL | Y | 1 | TENDS01 | TEN10002 | 2020-09-07 | 2020-09||||||||||
| A123 | A2001 | 13-Jan-21 | 6 | 36 | 021-01-08 | 2021-01-14 | Product B | e-nicotine liquid | 7 | mL | Y | 2 | TENDS01 | TEN10002 | 2020-09-14 | 2020-09-21||||||||||||
| A123 | A2001 | 14-Jan-21 | 7 | 42 | 021-01-08 | 2021-01-14 | Product B | e-nicotine liquid | 8 | mL | Y | 3 | |||||||||||||||
| TENDS01A123 | TEN10002A2001 | 202015-09Jan-21 | 2020-09-288 | 48.4 | 2021-01-15 | 2021-01-21 | Product B | e-nicotine liquid | 6.4 | mL | Y | 4 | TENDS01 | TEN10002 | 2020-09-28 | 2020-09-31||||||||||||
| A123 | A2001 | 16-Jan-21 | 9 | 54.8 | 2021-01-15 | 2021-01-21 | Product B | e-nicotine liquid | 7 | mL | Y | 5 | |||||||||||||||
| TENDS01A123 | TEN10002A2001 | 202017-Jan-21 | 10-31 | 2020-10-0861.2 | 2021-01-15 | 2021-01-21 | Product B | e-nicotine liquid | 8 | mL | Y | 6 | |||||||||||||||
| TENDS01A123 | TEN10002A2001 | 202018-10-08 | 2020-10-15Jan-21 | 11 | 67.6 | 2021-01-15 | 2021-01-21 | Product B | e-nicotine liquid | mL | 6.7 | mL | Y | 7 | TENDS01 | TEN10002 | 2020-10-15 | 2020-10-22 | Product B | e-nicotine liquid | 5.5 | mL | Y | Y | 7 | ||
| A123 | A2001 | 19-Jan-21 | 12 | 74 | 2021-01-15 | 2021-01-21 | Product B | e-nicotine liquid | mL | Y | 8 | ||||||||||||||||
| A123 | A2001 | 20-Jan-21 | 13 | 80.4 | 2021-01-15 | 2021-01-21 | |||||||||||||||||||||
| A123 | A2001 | 21-Jan-21 | 14 | 86.8 | 2021-01-15 | 2021-01-21 | |||||||||||||||||||||
| A123 | A2001 | 22-Jan-21 | 15 | 93.8 | 2021-01-22 | 2021-01-28 | 7 | ||||||||||||||||||||
| A123 | A2001 | 23-Jan-21 | 16 | 100.8 | |||||||||||||||||||||||
| A123 | A2001 | 24-Jan-21 | 17 | 107.8 | |||||||||||||||||||||||
| A123 | A2001 | 25-Jan-21 | 18 | 114.8 | |||||||||||||||||||||||
| A123 | A2001 | 26-Jan-21 | 19 | 121.8 | |||||||||||||||||||||||
| A123 | A2001 | 27-Jan-21 | 20 | 128.8 | |||||||||||||||||||||||
| A123 | A2001 | 28-Jan-21 | 21 | 135.8 | |||||||||||||||||||||||
| A123 | A2008 | 8-Feb-21 | 1 | 5 | 2021-02-08 | 2021-02-14 | 5 | ||||||||||||||||||||
| A123 | A2008 | 9-Feb-21 | 2 | 10 | |||||||||||||||||||||||
| A123 | A2008 | 10-Feb-21 | 3 | 15 | |||||||||||||||||||||||
| A123 | A2008 | 11-Feb-21 | 4 | 20 | |||||||||||||||||||||||
| A123 | A2008 | 12-Feb-21 | 5 | 25 | |||||||||||||||||||||||
| A123 | A2008 | 13-Feb-21 | 6 | 30 | |||||||||||||||||||||||
| A123 | A2008 | 14-Feb-21 | 7 | 35 | |||||||||||||||||||||||
| A123 | A2008 | 15-Feb-21 | 8 | 42 | 2021-02-15 | 2021-02-21 | 7 | ||||||||||||||||||||
| A123 | A2008 | 16-Feb-21 | 9 | 49 | |||||||||||||||||||||||
| A123 | A2008 | 17-Feb-21 | 10 | 56 | |||||||||||||||||||||||
| A123 | A2008 | 18-Feb-21 | 11 | 63 | |||||||||||||||||||||||
| A123 | A2008 | 19-Feb-21 | 12 | 70 | |||||||||||||||||||||||
| A123 | A2008 | 20-Feb-21 | 13 | 77 | |||||||||||||||||||||||
| A123 | A2008 | 21-Feb-21 | 14 | 84 | |||||||||||||||||||||||
| A123 | A2008 | 22-Feb-21 | 15 | 92 | 2021-02-22 | 2021-03-01 | 8 | ||||||||||||||||||||
| A123 | A2008 | 23-Feb-21 | 16 | 100 | |||||||||||||||||||||||
| A123 | A2008 | 24-Feb-21 | 17 | 108 | |||||||||||||||||||||||
| A123 | A2008 | 25-Feb-21 | 18 | 116 | |||||||||||||||||||||||
| A123 | A2008 | 26-Feb-21 | 19 | 124 | |||||||||||||||||||||||
| A123 | A2008 | 27-Feb-21 | 20 | 132 | |||||||||||||||||||||||
| A123 | A2008 | 28-Feb-21 | 21 | 140 | |||||||||||||||||||||||
| A123 | A2008 | 1-Mar-21 | 22 | 148 | |||||||||||||||||||||||
| A123 | A3009 | 9-Jun-21 | 1 | 8 | 2021-06-09 | 2021-06-15 | 8 | ||||||||||||||||||||
| A123 | A3009 | 10-Jun-21 | 2 | 16 | |||||||||||||||||||||||
| A123 | A3009 | 11-Jun-21 | 3 | 24 | |||||||||||||||||||||||
| A123 | A3009 | 12-Jun-21 | 4 | 32 | |||||||||||||||||||||||
| A123 | A3009 | 13-Jun-21 | 5 | 40 | |||||||||||||||||||||||
| A123 | A3009 | 14-Jun-21 | 6 | 48 | |||||||||||||||||||||||
| A123 | A3009 | 15-Jun-21 | 7 | 56 | |||||||||||||||||||||||
| A123 | A3009 | 16-Jun-21 | 8 | 62.7 | 2021-06-16 | 2021-06-21 | 6.7 | ||||||||||||||||||||
| A123 | A3009 | 17-Jun-21 | 9 | 69.4 | |||||||||||||||||||||||
| A123 | A3009 | 18-Jun-21 | 10 | 76.1 | |||||||||||||||||||||||
| A123 | A3009 | 19-Jun-21 | 11 | 82.8 | |||||||||||||||||||||||
| A123 | A3009 | 20-Jun-21 | 12 | 89.5 | |||||||||||||||||||||||
| A123 | A3009 | 21-Jun-21 | 13 | 96.28 |
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.TRT01A | |
| TRT01A | Actual Treatment for Period 01 | 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 | |
| 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 |
...
| STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | PARAM | PARAMCD | PARAMN | AVAL | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TENDS01A123 | TEN01001A2001 | Number of Doses | NDOSES | 1 | 21 | |||||||||||||
| A123 | A2001 | TENDS01 | TEN01001 | Average Daily Dose | TENDS01 | TEN01001 | Cumulative Dose | TENDS01 | TEN01001 | Total Dose | ADD | 2 | 6.466667 | |||||
| A123 | A2001 | Total Dose | TOTDOSE | 3 | 135.8 | |||||||||||||
| A123 | A2008 | Number of Doses | NDOSES | 1 | 22 | |||||||||||||
| A123 | A2008 | Average Daily Dose | ADD | 2 | 6.727273 | |||||||||||||
| A123 | A2008 | Total Dose | TOTDOSE | 3 | 148 | |||||||||||||
| A123 | A3009 | Number of Doses | NDOSES | 1 | 13 | |||||||||||||
| A123 | A3009 | Average Daily Dose | ADD | 2 | 7.4 | |||||||||||||
| A123 | A3009 | Total Dose | TOTDOSE | 3 | 96.2 | TENDS01 | TEN01002 | TENDS01 | TEN01002 |
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