In In this study, subjects were randomized to one of three 24-week conditions. 1 of 3 nicotine dosage levels. At the baseline visit (week 0), they receiving either received an ENDS ENDS device that used used 0, 8, or 36 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption were measured at all study visits (Weeks 1, 2, 4, 8, 12, )consumption was recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor applicant used an electronic e-diary application to track when the cartridge were replacedcartridges were inserted and removed, and the daily number of cigarettes smoked. The subject Subjects used their normal brand of cigarettes , and ; these were not supplied by the sponsorapplicant, and are not considered a study product. Each cartridge was 8 mL. No other nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.
Since, the subject regular cigarettes were not supplied by the sponsor, the sponsor elected to report this data as a Concomitant medication, in the CM domain. THe ENDS device use was represented in EC.
The applicant represented the cigarettes used in the SU domain. After the first visit, the number of cigarettes smoked for each day of the study were represented. If no cigarettes were smoked,(although "0" records are typically not included), 0 was recorded as the data was collected. Only a few rows are shown.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ |
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ECSEQECTRTECDOSEECDOSUECROUTEECSTDTCECENDTCEC10001 Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED| CIGARETTES | TOBACCO | 6 | CIGARETTE | QD | 2020-06-27 | 2020- |
0701EC10001 Electronic Nicotine Delivery System CONTAINERINHALED07010705EC10001 Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED| CIGARETTES | TOBACCO | 0 | CIGARETTE | QD | 2020- |
07052020-07-10 | | 4 | TENDS01 | EC | 10002 | 1 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 | EC | 10002 | 2 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 | EC | 10002 | 3 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 | EC | 10002 | 4 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 | EC | 10002 | 5 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 | EC | 10002 | 6 | Electronic Nicotine Delivery SystemP | 1 | CONTAINER | INHALED | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 | EC | 10002 | 7 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 | EC | 10002 | 8 | Electronic Nicotine Delivery System | 1 | CONTAINER | INHALED | 2020-10-15 | 2020-10-22 | |
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EX would report the unblinded exposure to nicotine. What should be reported???? We do not really have the real exposue...
The DA domain was used to represent dispensed and returned amounts. The ENDS product used in the study was assigned a product identifier (VAPE-Z27), and each cartridge had a uniquely assigned number. This unique number was represented in DAREFID. Multiple cartridges were dispensed at weekly visits, and each cartridge was tracked. At each weekly visit, all previously dispensed cartridges were returned and new cartridges dispensed. Cartridges were replaced at each visit. DADTC are the visit dates when the cartridge was returned or dispensed. Cartridges not used were recorded as having the full volume returned.
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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 | TEN01001 | | VAPE-Z27 | CRT8754 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2020-06-26 | | 2 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8768 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2020-06-26 | | 3 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8769 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 1 | 2020-06-26 | | 4 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8754 | RETAMT | Returned Amount | STUDY PRODUCT | 2 | mL | 2 | 2 | mL | 2 | 2020-07-06 | | 2 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8768 | RETAMT | Returned Amount | STUDY PRODUCT | 1.6 | mL | 1.6 | 1.6 | mL | 2 | 2020-07-06 | | 3 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT8769 | RETAMT | Returned Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 5 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT9756 | DISPAMT | Dispensed Amount | STUDY PRODUCT | 8 | mL | 8 | 8 | mL | 2 | 2020-07-06 | | 6 | TENDS01 | DA | TEN01001 | | VAPE-Z27 | CRT9756 | RETAMT | Returned Amount | STUDY PRODUCT | 1 | mL | 1 | 1 | mL | 3 | 2020-07-10 |
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Because the data in EC would be practically identical to the summarized EX domain, the applicant did not submit the EC domain. The applicant 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 applicant used an e-diary to collect the start and end date of the insertion and removal date of each cartridge in the ENDS device. For simplicity, in this example the actual times of insertion/removal were not collected, although this may often be collected.
The total amount of liquid product used from each cartridge was determined using the data in the DA domain. The associated nicotine pharmaceutical strength of each cartridge was known. The applicant 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 |
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EXDOSRGM| EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXPSTRG | EXPSTRGU | EXSTDTC | EXENDTC |
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| 1 | TENDS01 | EX |
10001 Electronic Nicotine Delivery System | 0 mg nicotine liquid | INHALED| VAPE-Z27 | CRT8754 | Nicotine e-liquid | 6 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 2020-06- |
27EC10001 Electronic Nicotine Delivery System | 0 mg nicotine liquid | CONTAINER | | VAPE-Z27 | CRT8768 | Nicotine e-liquid | 6.4 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL |
INHALED05EC10001 Electronic Nicotine Delivery System | 0 mg nicotine liquid | CONTAINER | | Nicotine e-liquid | 7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL | 2020-07-06 | 2020-07-10 | | 3 | TENDS01 | EX | TEN01001 | 4 | VAPE-Z27 | CRT9778 | Nicotine e-liquid | 8 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 8 | mg/mL |
INHALED0510EC10002Electronic Nicotine Delivery System | 8x36 ml nicotine liquid | CONTAINER | | VAPE-Z27 | CRT8000 | Nicotine e-liquid | 5 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-09-01 | 2020-09-07 | | 5 | TENDS01 |
EC10002 Electronic Nicotine Delivery System | 8x36 ml nicotine liquid0 mg nicotine liquid | CONTAINER | | VAPE-Z27 | CRT9006 | Nicotine e-liquid | 7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-09-07 | 2020-09-14 | | 6 | TENDS01 |
EC10002 Electronic Nicotine Delivery System | 8x36 ml nicotine liquid | CONTAINER | | VAPE-Z27 | CRT9008 | Nicotine e-liquid | 8 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-09-14 | 2020-09-21 | | 7 | TENDS01 |
EC10002 Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | | VAPE-Z27 | CRT9017 | Nicotine e-liquid | 6 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-09-21 | 2020-09-28 | | 8 | TENDS01 |
EC10002 Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | | VAPE-Z27 | CRT9089 | Nicotine e-liquid | 7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-09-28 | 2020-09-31 | | 9 | TENDS01 |
EC10002 Electronic Nicotine Delivery SystemP | 8x36 ml nicotine liquid1 | CONTAINER | | VAPE-Z27 | CRT9128 | Nicotine e-liquid | 8 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-10-31 | 2020-10-08 | | 10 | TENDS01 |
EC10002 Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | | VAPE-Z27 | CRT6868 | Nicotine e-liquid | 6.7 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED | 2020-10-08 | 2020-10-15 | | 11 | TENDS01 |
EC10002 Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | | VAPE-Z27 | CRT7868 | Nicotine e-liquid | 5.5 | mL | CARTRIDGE | RESPIRATORY (INHALATION) | 0 | mg/mL |
INHALED |
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