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| SDTM Example.ADEX Exposure |
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| SDTM Example.ADEX Exposure |
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This is an example of the ADEX dataset and associated metadata.
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Dataset2 |
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STUDYID | USUBJID | ASTDT | AENDT | ASTDY | AENDY | EXSTDTC | EXENDTC | TRTP | EXTRT | EXDOSE | EXDOSU | SAFFL | EXSEQ |
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A123 | A2001 |
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| 2020-06-26 | 2020-07-01 | Placebo | e-nicotine liquid | 6 | mL | Y | 1 | A123 | A2001 |
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| 2020-07-01 | 2020-07-06 | Placebo | e-nicotine liquid | 6.4 | mL | Y | 2 | A123 | A2001 |
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| 2020-07-06 | 2020-07-10 | Placebo | e-nicotine liquid | 7 | mL | Y | 3 | A123 | A2008 |
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| 2020-07-10 | 2020-07-14 | Product A | e-nicotine liquid | 8 | mL | Y | 4 | A123 | A2008 |
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| 2020-09-01 | 2020-09-07 | Product A | e-nicotine liquid | 5 | mL | Y | 1 | A123 | A2008 |
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| 2020-09-07 | 2020-09-14 | Product A | e-nicotine liquid | 7 | mL | Y | 2 | A123 | A3009 |
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| 2020-09-14 | 2020-09-21 | Product B | e-nicotine liquid | 8 | mL | Y | 3 | A123 | A3009 |
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| 2020-09-21 | 2020-09-28 | Product B | e-nicotine liquid | 6 | mL | Y | 4 |
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Definexmltable |
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Dataset | ADEX |
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Level | Variable |
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Purpose | Analysis |
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| | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes | STUDYID | Study Identifier | text |
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| EX.STUDYID | USUBJID | Unique Subject Identifier | text |
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| EX.USUBJID | ASTDT | Analysis Start Date | integer |
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| numeric SAS date variable based on EXSTDTC with no imputation for partial dates | AENDT | Analysis End Date | integer |
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| numeric SAS date variable based on EXENDTC with no imputation for partial dates | ASTDY | Analysis Start Relative Day | integer |
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| ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT | AENDY | Analysis End Relative Day | integer |
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| AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT | EXSTDTC |
| text |
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| EX.EXSTDTC | EXENDTC |
| text |
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| EX.EXENDTC | TRTP |
| text |
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| ADSL.TRT01P | EXTRT |
| text |
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| EX.EXTRT | EXDOSE |
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| EX.EXDOSE | EXDOSU |
| text |
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| EX.EXDOSU | SAFFL |
| text |
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| ADSL.SAFFL | EXSEQ |
| integer |
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| EX.EXSEQ |
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