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ADEX metadata
Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
| STUDYID | Study Identifier | text | EX.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | EX.USUBJID | ||
| ASTDT | 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 | ||
| ASTDY | 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 | ||
| EXSTDTC | text | EX.EXSTDTC | |||
| EXENDTC | text | EX.EXENDTC | |||
| TRTP | text | ADSL.TRT01P | |||
| EXTRT | text | EX.EXTRT | |||
| EXDOSE | EX.EXDOSE | ||||
| EXDOSU | text | EX.EXDOSU | |||
| SAFFL | text | ADSL.SAFFL | |||
| EXSEQ | integer | EX.EXSEQ |
ADEX dataset
| STUDYID | USUBJID | ASTDT | AENDT | ASTDY | AENDY | EXSTDTC | EXENDTC | TRTP | EXTRT | EXDOSE | EXDOSU | SAFFL | EXSEQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TENDS01 | TEN01001 | 2020-06-26 | 2020-07-01 | Product A | e-nicotine liquid | 6 | mL | Y | 1 | ||||
| TENDS01 | TEN01001 | 2020-07-01 | 2020-07-06 | Product A | e-nicotine liquid | 6.4 | mL | Y | 2 | ||||
| TENDS01 | TEN01001 | 2020-07-06 | 2020-07-10 | Product A | e-nicotine liquid | 7 | mL | Y | 3 | ||||
| TENDS01 | TEN01001 | 2020-07-10 | 2020-07-14 | Product A | e-nicotine liquid | 8 | mL | Y | 4 | ||||
| TENDS01 | TEN10002 | 2020-09-01 | 2020-09-07 | Product B | e-nicotine liquid | 5 | mL | Y | 1 | ||||
| TENDS01 | TEN10002 | 2020-09-07 | 2020-09-14 | Product B | e-nicotine liquid | 7 | mL | Y | 2 | ||||
| TENDS01 | TEN10002 | 2020-09-14 | 2020-09-21 | Product B | e-nicotine liquid | 8 | mL | Y | 3 | ||||
| TENDS01 | TEN10002 | 2020-09-21 | 2020-09-28 | Product B | e-nicotine liquid | 6 | mL | Y | 4 | ||||
| TENDS01 | TEN10002 | 2020-09-28 | 2020-09-31 | Product B | e-nicotine liquid | 7 | mL | Y | 5 | ||||
| TENDS01 | TEN10002 | 2020-10-31 | 2020-10-08 | Product B | e-nicotine liquid | 8 | mL | Y | 6 | ||||
| TENDS01 | TEN10002 | 2020-10-08 | 2020-10-15 | Product B | e-nicotine liquid | 6.7 | mL | Y | 7 | ||||
| TENDS01 | TEN10002 | 2020-10-15 | 2020-10-22 | Product B | e-nicotine liquid | 5.5 | mL | Y | 8 |
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 |
ADEXSUM data
| STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | PARAM | PARAMCD | PARAMN | AVAL |
|---|---|---|---|---|---|---|---|---|---|
| TENDS01 | TEN01001 | Number of Doses | |||||||
| TENDS01 | TEN01001 | Average Dose | |||||||
| TENDS01 | TEN01001 | Cumulative Dose | |||||||
| TENDS01 | TEN01001 | Total Dose | |||||||
| TENDS01 | TEN01002 | ||||||||
| TENDS01 | TEN01002 |
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