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Questions: 

1: Studies may be interested in the number of product used per day, and studies never associated the product itself with nicotine exposure. Hence, the unit for the exposure domains would be amount of product- and no specific details provided about the nicotine amounts. Nicotine, is just analysis using the biomarkers.  

Product could be number of cigarettes, number of NRT ( patch, gum etc) . Could  also use volume, or weight of the product.  

2: Studies may be interested in information about the nicotine , as well as the numbers of product used.  This would be represented  in pharmateuctical strengh, and the total amount of the vehicle  and the nicotine. using VAMT . Needs to look at SDTM rules.   

3. When only the amount of product used is of interest, then blinding   

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Use container such as a cartridge or tank.  Hence used CT of container  to be generic. 

DOSEU  - QUID is not included in CT. 

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More unit codes as well- PACK, PACKAGE, CIGAR, Cigarettes. POUCH,  

1. 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. 

...

More unit codes as well- PACK, PACKAGE, CIGAR, Cigarettes. POUCH,  

 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.   

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.        

No other nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.   

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.