This is an example of an ADEX dataset and is based primarily on input from the SDTM EX dataset. Other adminstrative data about the subjects are based on the ADSL datset provided ... > add the link.
This is an example of the input SDTM EX dataset used to create the ADEX. Only variables needed for illustration are shown in the example.
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID | EXREFID | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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| 1 | A123 | EX | A2001 | 1 | VAPE-Z27 | CRT8754 | e-nicotine liquid | 6 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL | 2021-01-08 | 2020-01-14 | | 2 | A123 | EX | A2001 | 2 | VAPE-Z27 | CRT8768 | e-nicotine liquid | 6.4 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL | 2021-01-15 | 2020-01-21 | | 3 | A123 | EX | A2001 | 3 | VAPE-Z27 | CRT9756 | e-nicotine liquid | 7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL | 2021-01-22 | 2020-01-28 | | 4 | A123 | EX | A2008 | 1 | VAPE-Z27 | CRT8000 | e-nicotine liquid | 5 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 20221-02-08 | 2021-02-14 | | 5 | A123 | EX | A2008 | 2 | VAPE-Z27 | CRT9006 | e-nicotine liquid | 7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 20221-02-15 | 2021-02-21 | | 6 | A123 | EX | A2008 | 3 | VAPE-Z27 | CRT9008 | e-nicotine liquid | 8 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 20221-02-22 | 2021-03-01 | | 7 | A123 | EX | A3009 | 1 | VAPE-Z27 | CRT9128 | e-nicotine liquid | 8 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 4 | mg/mL | 2021-06-09 | 2021-06-15 | | 8 | A123 | EX | A3009 | 2 | VAPE-Z27 | CRT6868 | e-nicotine liquid | 6.7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 4 | mg/mL | 2021-06-16 | 2021-06-21 |
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This is an example of the ADEX dataset and associated metadata.
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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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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADEX |
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| | Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADEX |
| SET | One record per subject | Analysis |
| ADEX.xpt | ADEX.SAS/SAP | |
| 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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