In this study, subjects were randomized to one of three 24-week conditions. At the baseline visit, they receiving either an ENDS device that used 0, 8 or 36 mg/ml nicotine liquid . Self-reported daily cigarette consumption were measured at all study visits (Weeks 1, 2, 4, 8, 12, ). The subjects were supplied replacement nicotine cartridges. The start and end date of the use of each cartridge was collected. Other nicotine, or nicotine replacement therapy use was no collected. IN this study, the sponsor elected to submit only the EX domain as the data for each dispensed cartridge was reported. either nicotine replacement patches or ENDS devices using e-nicotine liquid cartridges. In order to maintain the blind, subjects used both the nicotine replacement patches and the ENDS devices. Subjects were requested not to smoke, but the number of regular cigarettes used were collected. Subject were seen every day for 15 days. The nicotine patch was applied, at rotating sites, and the nicotine cartridge was replaced every day. The cartridge was weighed when dispensed and upon return. On days, 1, 5, and 10 subjects remained in the clinic for 4 hours for collection of biomarkers. On these days, a new ENDS nicotine cartridge was inserted and 10 puffs were taken over 10 minutes, and not used for the remaining collection period. A new cartridge was inserted at the end of the 4-hour collection period. A nicotine replacement patch was applied prior to using the ENDS device on these days.
The SU domain was used to represent the number of cigarettes used, but is not shown.
In this study, the weight of the contents in the cartridge was tracked. The DA domain was used to represent dispensed and returned weights of each cartridge. Only a few rows are shown. The product accountability information was not provided for the nicotine replacement patches.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | DASEQ | DAREFID | DATESTCD | DATEST | DACAT | DASCAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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1 | TEDP07 | DA | 10001 | | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.3 | g | 25 | 25 | g | 1 | 2004-06-06 | 2 | TEDP07 | DA | 10001 | | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 23 | g | 23 | 23 | g | 1 | 2020-06-06 | 3 | TEDP07 | DA | 10001 | | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.1 | g | 25 | 25 | g | 1 | 2020-06-07 | 4 | TEDP07 | DA | 10001 | | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | E-LIQUID | 10 | g | 14 | 14 | g | 2 | 2020-06-08 | 5 | TEDP07 | DA | 10001 | | CRT9955 | DISPAMT | Dispensed Amount | STUDY PRODUCT | E-LIQUID | 25.2 | g | 25 | 25 | g | 2 | 2004-06-08 |
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EC was used to represent the collected exposure data since a double-blind design was used. The EX domain was used to represent the subject's exposure to the actual product containing nicotine. The applicant represented each cartridge and patch used. The dose was represented as "1" to indicate 1 cartridge or patch. The actual date and specific time of usage of the cartridge was recorded on days 1, 5, and 10, while only the date of usage was recorded on other days.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSTXT | ECDOSU | ECDOSFRM | ECROUTE | ECLOC | ECLAT | ECDIR | EPOCH | ECSTDTC | ECENDTC |
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1 | TEDP07 | EC | 10001 | 1 | ENDS | 10 |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-01T08:00 | 2020-06-01T08:10 |
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2 | TEDP07 | EC | 10001 | 2 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | ARM | RIGHT | UPPER | PRODUCT EXPOSURE | 2020-06-01 | 2020-06-02 |
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3 | TEDP07 | EC | 10001 | 3 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-01T12:10 | 2020-06-02 |
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4 | TEDP07 | EC | 10001 | 4 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-02 | 2020-06-03 |
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5 | TEDP07 | EC | 10001 | 5 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | ARM | LEFT | UPPER | PRODUCT EXPOSURE | 2020-06-02 | 2020-06-03 |
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6 | TEDP07 | EC | 10001 | 6 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-03 | 2020-06-04 |
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7 | TEDP07 | EC | 10001 | 7 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | LEG | LEFT | UPPER | PRODUCT EXPOSURE | 2020-06-03 | 2020-06-04 |
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7 | TEDP07 | EC | 10001 | 8 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-04 | 2020-06-05 |
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8 | TEDP07 | EC | 10001 | 9 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | LEG | LEFT | LOWER | PRODUCT EXPOSURE | 2020-06-04 | 2020-06-05 |
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9 | TEDP07 | EC | 10001 | 10 | ENDS | 10 |
| PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-10T8:30 | 2020-06-10T8:40 |
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10 | TEDP07 | EC | 10001 | 11 | PATCH | 1 |
| PATCH | PATCH | TRANSDERMAL | LEG | RIGHT | LOWER | PRODUCT EXPOSURE | 2020-06-10 | 2020-06-11 |
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11 | TEDP07 | EC | 10001 | 12 | ENDS |
| AD LIBITUM | PUFF | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 2020-06-10T12:40 | 2020-06-11 |
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Subject 10001 was randomized to the 5% pharmaceutical strength of the nicotine e-liquid, and subject 20001 was randomized to the nicotine patch with a pharmaceutical strength of 14mg. The applicant only represented the active product exposure for each subject in EX.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXLOC | EXLAT | EXDIR | EPOCH | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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1 | TEDP07 | EX | 10001 | 1 | e nicotine liquid | 1.7 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-01T08:00 | 2020-06-01T:8:10 |
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2 | TEDP07 | EX | 10001 | 2 | e nicotine liquid | 15.1 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-01T12:10 | 2020-06-02 |
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3 | TEDP07 | EX | 10001 | 3 | e nicotine liquid | 13 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-02 | 2020-06-03 |
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4 | TEDP07 | EX | 10001 | 4 | e nicotine liquid | 12 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-03 | 2020-06-04 |
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5 | TEDP07 | EX | 10001 | 5 | e nicotine liquid | 9 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-04 | 2020-06-05 |
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6 | TEDP07 | EX | 10001 | 6 | e nicotine liquid | 7 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-10T08:30 | 2020-06-10T08:40 |
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7 | TEDP07 | EX | 10001 | 7 | e nicotine liquid | 5 | g | CARTRIDGE | RESPIRATORY (INHALATION) |
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| PRODUCT EXPOSURE | 5 | % | 2020-06-10T12:40 | 2020-06-11 |
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8 | TEDP07 | EX | 20001 | 1 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | ARM | RIGHT | UPPER | PRODUCT EXPOSURE | 14 | mg | 2020-06-01 | 2020-06-02 |
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9 | TEDP07 | EX | 20001 | 2 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | ARM | LEFT | UPPER | PRODUCT EXPOSURE | 14 | mg | 2020-06-02 | 2020-06-03 |
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10 | TEDP07 | EX | 20001 | 3 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | LEFT | UPPER | PRODUCT EXPOSURE | 14 | mg | 2020-06-03 | 2020-06-04 |
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11 | TEDP07 | EX | 20001 | 4 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | LEFT | LOWER | PRODUCT EXPOSURE | 14 | mg | 2020-06-04 | 2020-06-05 |
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12 | TEDP07 | EX | 20001 | 5 | nicotine replacement therapy | 1 | PATCH | PATCH | TRANSDERMAL | LEG | RIGHT | LOWER | PRODUCT EXPOSURE | 14 | mg | 2020-06-10 | 2020-06-11 |
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