EX/EC Exposure ENDS Example 1

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.  No other Nicotine replacement products were allowed to be used.  

The subject regular cigarettes were not supplied by the sponsor, and not considered a study product by the sponsor.  The sponsor reported the cigarettes used in the in the SU domain.  The SU domain is not shown here, but an example is shown in xxxxxx. 

Since the data in Exposure as collected would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain.  A Product Accountability domain was submitted to represent dispensed and returned amounts, but this data was not used in determining exposure. It was used by the sponsor when reviewing the exposure data for each subject. This DA domain is not shown here.    

Note, 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 domain represented the amount of product used, the total amount amount of liquid product ( including all is components) used from each cartridge and the associated nicotine pharmaceutical strength of each cartridge. 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 exposer from the cartridges per day.    

Since the data in Exposure as collected would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain.  The DA domain was used to capture the amount of nicotine dispensed and returned for each cartridge. 

Note, the sponsor unblinded the study before creating the EX domain. The unblinded product name is used in EXTRT.  

The  DA domain contained the amount dispensed and returned for each cartridge.  Each cartiridge had a unique number assigned. This  was represented in DAREF.