In this study, subjects were randomized to one of three nicotine dosage levels. At the baseline visit (Week 0), they receiving an ENDS device that used 0, 8 or 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption were recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor used an electronic diary application to track when the cartridges were replacedinserted and removed, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes, and these were not supplied by the sponsor, and not considered a study product. Each cartridge was 8 mL. No other Nicotine nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.
The sponsor reported the cigarettes used in the in the SU domain. The number of cigarettes smoked for each day of the study after the first visit were represented. If no cigarettes were smoked, a 0 was recorded. Only a few rows are shown.
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC |
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| 1 | TENDS01 | SU | ABC-01001TEN01001 | 1 | CIGARETTES | TOBACCO | 6 | CIGARETTE | PER DAY | 2020-06-27 | 2020-06-27 | | 2 | TENDS01 | SU | ABC-01001TEN01001 | 12 | CIGARETTES | TOBACCO | 1 | CIGARETTE | PER DAY | 2020-06-28 | 2020-06-28 | | 3 | TENDS01 | SU | ABC-01001TEN01001 | 13 | CIGARETTES | TOBACCO | 0 | CIGARETTE | PER DAY | 2020-06-29 | 2020-06-29 |
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| Row | STUDYID | DOMAIN | USUBJID | DASEQ | SPTOBID | DAREFID | DATESTCD | DATEST | DACAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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| 1 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 2 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT8768 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 3 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT8769 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2004-06-26 | | 4 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | 2 | mL | 6 | 6 | mL | 2 | 2020-07-06 | | 2 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT8768 | RETAMT | Returned Amount | STUDY PRODUCT | 1.6 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 3 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT8769 | RETAMT | Returned Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 5 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 6 | TENDS01 | DA | ABC-01001TEN01001 | | VAPE-Z27 | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | 1.0 | mL | 1.3 | 1.3 | mL | 3 | 2020-07-10 |
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Since the data in Exposure as collected (EC) would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.
The sponsor used the electronic diary to determine the start and end date of each cartridge. For simplicity, in this example ,the actual times were not used.
The domain represented the total amount of liquid product used from each cartridge which domain represented the number of cartridges used (in this example always 1 since each cartridge was tracked), the total amount amount of liquid product used was determined from the DA domain and the . The associated nicotine pharmaceutical strength of each cartridge was known. The sponsored used this information in the analysis. The summaries included in the analysis were the estimated number of cartridges used per week, and the estimated nicotine exposure from the cartridges per day.
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | SPTOBID | EXREFID | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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| 1 | TENDS01 | EX | 10001TEN01001 | 1 | VAPE-Z27 | CRT8754 | e-nicotine liquid | 6 | mL | INHALED | 8 | mg/mL | 2020-06-26 | 2020-07-01 | | 2 | TENDS01 | EX | 10001TEN01001 | 2 | VAPE-Z27 | CRT8768 | e-nicotine liquid | 6.74 | mL | INHALED | 8 | mg/mL | 2020-07-01 | 2020-07-06 | | 3 | TENDS01 | EX | 10001TEN01001 | 3 | VAPE-Z27 | CRT9756 | e-nicotine liquid | 7 | mL | INHALED | 8 | mg/mL | 2020-07-06 | 2020-07-10 | | 3 | TENDS01 | EX | 10001TEN01001 | 4 | VAPE-Z27 | CRT9778 | e-nicotine liquid | 8 | mL | INHALED | 8 | mg/mL | 2020-07-10 | 2020-07-14 | | 4 | TENDS01 | EX | 10002TEN10002 | 1 | VAPE-Z27 | CRT8000 | e-nicotine liquid | 5 | mL | INHALED | 24 | mg/mL | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EX | 10002TEN10002 | 2 | VAPE-Z27 | CRT9006 | e-nicotine liquid | 7 | mL | INHALED | 24 | mg/mL | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EX | 10002TEN10002 | 3 | VAPE-Z27 | CRT9008 | e-nicotine liquid | 8 | mL | INHALED | 24 | mg/mL | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EX | 10002TEN10002 | 4 | VAPE-Z27 | CRT9017 | e-nicotine liquid | 6 | mL | INHALED | 24 | mg/mL | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EX | 10002TEN10002 | 5 | VAPE-Z27 | CRT9089 | e-nicotine liquid | 7 | mL | INHALED | 24 | mg/mL | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EX | 10002TEN10002 | 6 | VAPE-Z27 | CRT9128 | e-nicotine liquid | 8 | mL | INHALED | 24 | mg/mL | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EX | 10002TEN10002 | 7 | VAPE-Z27 | CRT6868 | e-nicotine liquid | 6.7 | mL | INHALED | 24 | mg/mL | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EX | 10002TEN10002 | 8 | VAPE-Z27 | CRT7868 | e-nicotine liquid | 5.5 | mL | INHALED | 24 | mg/mL | 2020-10-15 | 2020-10-22 |
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