- When the EC domain is implemented in conjunction with the EX domain, EXVAMT and EXVAMTU would not be used in EX; collected values instead would be represented in ECDOSE and ECDOSU (and ECVAMT and ECVAMTU as needed).
Use container such as a cartridge or tank. Hence used CT of container to be generic.
DOSEU - QUID is not included in CT.
CAN | Can Dosing Unit | A dosing measurement based on the can unit.(NCI) | Can Dosing Unit |
CONTAINER | Container Dosing Unit | A dosing measurement based on the container unit.(NCI) | Container Dosing Unit |
CIGAR | Cigar Dosing Unit | A dosing measurement based on the cigar unit. |
CIGARETTE | Cigarette Dosing Unit | A dosing measurement based on the cigarette unit. |
PUFF | Puff Dosing Unit | A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) |
CARTRIDGE | Cartridge Dosing Unit | A dosing measurement based on the cartridge unit.(NCI) |
More unit codes as well- PACK, PACKAGE, CIGAR, Cigarettes. POUCH,
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 sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes , and these were not supplied by the sponsor. Each cartridge was 8 mL.
Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e-pipes are some of the many tobacco product terms used to describe electronic nicotine delivery systems (ENDS). These products use an “e-liquid” that usually contains nicotine derived from tobacco, as well as flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated to create an aerosol that the user inhales.
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 exposure use was represented in EC.
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Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECDOSE | ECDOSU | ECROUTE | ECVAMT | ECVAMU | ECSTDTC | ECENDTC |
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1 | TENDS01 | EC | 10001 | 1 | Liquid Nicotine e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-06-27 | 2020-07-01 | 2 | TENDS01 | EC | 10001 | 2 |
Electro nic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-07-01 | 2020-07-05 | 3 | TENDS01 | EC | 10001 | 3 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-07-05 | 2020-07-10 | 4 | TENDS01 | EC | 10002 | 1 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-01 | 2020-09-07 | 5 | TENDS01 | EC | 10002 | 2 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-07 | 2020-09-14 | 6 | TENDS01 | EC | 10002 | 3 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-14 | 2020-09-21 | 7 | TENDS01 | EC | 10002 | 4 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-21 | 2020-09-28 | 8 | TENDS01 | EC | 10002 | 5 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-09-28 | 2020-09-31 | 9 | TENDS01 | EC | 10002 | 6 | Electronic Nicotine Delivery SystemPe-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-31 | 2020-10-08 | 10 | TENDS01 | EC | 10002 | 7 | Electronic Nicotine Delivery System e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mL | 2020-10-08 | 2020-10-15 | 11 | TENDS01 | EC | 10002 | 8 | Electronic Nicotine Delivery System 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. What should be reported???? We do not really have the real exposue..this really just unblinds the subjects.
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRG | EXSTDTC | EXENDTC |
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1 | TENDS01 | EX | 10001 | 1 |
Electronic Nicotine Delivery System | 0 mg e-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mg/mL | 2020-06-27 | 2020-07-01 | 2 | TENDS01 | EC | 10001 | 2 |
Electronic Nicotine Delivery System | 0 mg nicotine liquid | CONTAINER | INHALED | 8 | mg/mL | 2020-07-01 | 2020-07-05 | 3 | TENDS01 | EC | 10001 | 3 |
Electronic Nicotine Delivery System | 0 mg nicotine liquide-nicotine liquid | 1 | CONTAINER | INHALED | 8 | mg/mL | 2020-07-05 | 2020-07-10 | 4 | TENDS01 | EC | 10002 | 1 |
Electronic Nicotine Delivery System | 8x36 ml nicotine liquide-nicotine liquid | 1 | CONTAINER | INHALED | 36 | mg/mL | 2020-09-01 | 2020-09-07 | 5 | TENDS01 | EC | 10002 | 2 |
Electronic Nicotine Delivery System | 8x36 mg nicotine liquid0 mg nicotine liquide-nicotine liquid | 1 | CONTAINER | INHALED | 36 | mg/mL | 2020-09-07 | 2020-09-14 | 6 | TENDS01 | EC | 10002 | 3 |
Electronic Nicotine Delivery System | 8x36 mg nicotine liquide-nicotine liquid | 1 | CONTAINER | INHALED | 36 | mg/mL | 2020-09-14 | 2020-09-21 | 7 | TENDS01 | EC | 10002 | 4 |
Electronic Nicotine Delivery System | 8x36 mg nicotine liquid1e-nicotine liquid | 1 | CONTAINER | INHALED | 36 | mg/mL | 2020-09-21 | 2020-09-28 | 8 | TENDS01 | EC | 10002 | 5 |
Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1e-nicotine liquid | 1 | CONTAINER | INHALED | 36 | mg/mL | 2020-09-28 | 2020-09-31 | 9 | TENDS01 | EC | 10002 | 6 |
Electronic Nicotine Delivery SystemP | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 36 | mg/mL | 2020-10-31 | 2020-10-08 | 10 | TENDS01 | EC | 10002 | 7 |
Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | INHALED | 2020-10-08 | 2020-10- | e-nicotine liquid | 1 | CONTAINER | INHALED | 36 | mg/mL | 2020-10-08 | 2020-10-15 | 11 | TENDS01 | EC | 10002 | 8 | e-nicotine liquid | 1 | CONTAINER | INHALED | 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 |
| Electronic Nicotine Delivery System | 8x36 ml nicotine liquid1 | CONTAINER | e-nicotine liquid | 7 | mL | INHALED | 36 | mg/mL |
INHALED