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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSU | ECROUTE | ECVAMT | ECVAMUECVAMT | ECSTDTC | ECENDTC |
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| 1 | TENDS01 | EC | 10001 | 1 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-06-27 | 2020-07-01 | | 2 | TENDS01 | EC | 10001 | 2 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-07-01 | 2020-07-05 | | 3 | TENDS01 | EC | 10001 | 3 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-07-05 | 2020-07-10 | | 4 | TENDS01 | EC | 10002 | 1 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EC | 10002 | 2 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EC | 10002 | 3 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EC | 10002 | 4 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EC | 10002 | 5 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EC | 10002 | 6 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EC | 10002 | 7 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EC | 10002 | 8 | e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-15 | 2020-10-22 |
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EX would report the unblinded exposure to e-nicotine liquid. this really just unblinds the subjects.
1) The dose may be the actual volume of liquid used over the interval represented in the dates, or that 1 container was used, or xxx.
2. IF amount of product used ( Numer of pouches, number of cigarettes, etc then we may be able to use VAMT, and Pharmaceutical strength to provide more details.
3. Some sponsor may leave these details to an ADaM datset, and provide really only collected data for the exposure.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXROUTE | ECXAMT | EXVAMTU
| EXPSTRG | EXPSTRG | EXSTDTC | EXENDTC |
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| 1 | TENDS01 | EX | 10001 | 1 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 8 | mg/mL | 2020-06-27 | 2020-07-01 | | 2 | TENDS01 | EC | 10001 | 2 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 8 | mg/mL | 2020-07-01 | 2020-07-05 | | 3 | TENDS01 | EC | 10001 | 3 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 8 | mg/mL | 2020-07-05 | 2020-07-10 | | 4 | TENDS01 | EC | 10002 | 1 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EC | 10002 | 2 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EC | 10002 | 3 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EC | 10002 | 4 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EC | 10002 | 5 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EC | 10002 | 6 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EC | 10002 | 7 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EC | 10002 | 8 | e-nicotine liquid | 1 | CONTAINER | INHALED |
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| 36 | mg/mL | 2020-10-15 | 2020-10-22 |
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In this case, i get the volume used from DA and derive this. | Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRG | EXSTDTC | EXENDTC |
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| 1 | TENDS01 | EX | 10001 | 1 | e-nicotine liquid | 7 | mL | INHALED | 8 | mg/mL | 2020-06-27 | 2020-07-01 | | 2 | TENDS01 | EC | 10001 | 2 | e-nicotine liquid | 6 | mL | INHALED | 8 | mg/mL | 2020-07-01 | 2020-07-05 | | 3 | TENDS01 | EC | 10001 | 3 | e-nicotine liquid | 7 | mL | INHALED | 8 | mg/mL | 2020-07-05 | 2020-07-10 | | 4 | TENDS01 | EC | 10002 | 1 | e-nicotine liquid | 6 | mL | INHALED | 36 | mg/mL | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EC | 10002 | 2 | e-nicotine liquid | 5 | mL | INHALED | 36 | mg/mL | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EC | 10002 | 3 | e-nicotine liquid | 8 | mL | INHALED | 36 | mg/mL | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EC | 10002 | 4 | e-nicotine liquid | 8 | mL | INHALED | 36 | mg/mL | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EC | 10002 | 5 | e-nicotine liquid | 8 | mL | INHALED | 36 | mg/mL | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EC | 10002 | 6 | e-nicotine liquid | 8 | mL | INHALED | 36 | mg/mL | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EC | 10002 | 7 | e-nicotine liquid | 7 | mL | INHALED | 36 | mg/mL | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EC | 10002 | 8 | e-nicotine liquid | 7 | mL | INHALED | 36 | mg/mL | 2020-10-15 | 2020-10-22 |
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