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Questions: 

Exposure collect may be be used to provided information on the amount of product used, or the amount of product used and the associated nicotine content. 

1. Product used can be reflect in the number of the product used -number of cigarettes, number of patch, etc.   

      2.  Additionally, some sponsor may be interested in the amount of nicotine in the product itself. 

      3. The actual exposure to nicotine is typically analyzed using biomarkers,  measuring actual nicotine exposure from self-reported use can be challenging. 

The sponsor needs to decide what level of exposure information is needed for the particular study. 

EC was developed to allow the collection of exposure data as typically the actual exposure amount may be blinded. 

EX would at a minimal be provided. It is recognized that  EX is a derived domain. Some sponsor find it easier to report the collected data and the derived EX data to clearly provided exposure data with the tracking to what was collected.   In many cases, the derivation for EX, may just  be the unblinding of the product, and sponsor decide not to show the EC because the derivation used for EX is obvious.  Some  other details may be defined in an ADaM  dataset.  For example, the estimated daily nicotine exposure may based on self-reported may be provided. Since, thee are estimates, they are typically not reported in EX.     

There are many ways to represent this data- we can show several options. We would like input on what is typically done. We can show several examples.    

We looked at ENDS- we collect amount of product used. We know the amount of e-liquid contained in the product when pre-filled containers are used. We also know the concentration of nicotine in the e-liquid. The study analysis plan decide what is of interest in the study     

We looked at SDTM and would like to discuss options for representing  this information. First , we looked at the derived EX dataset.  

EX would report the unblinded exposure to e-nicotine liquid. 

1) The dose may be the actual volume of liquid used over the interval represented in the dates, or that x containers were used, or weight of the container etc.   

This  EX dataset attempts to provide all the basic information.   

For example- SDTM has variables  like  

...

In this dataset , I showed  all three data points-  

...

...

Various options exist . This example however, exclude the amount of product used. This could be shown in EC.   

In this case, i get the volume used from DA and derive this. 

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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. 

...

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 this study, subjects were randomized to one of three 24-week conditions.In this study, the subject were assigned to one of three different ENDS products . In this study,  At the baseline visit, they receiving either an ENDS  device that used  0, 8 or 36 mg/ml g of 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 and NRT used.  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.        

40 mg.   The subject were allowed to continue the used of their regular cigarettes, and use Nicotine Replacement therapy (Gum, patches, etc) as needed.   

The sponsor decided to represent the data reported on the study product usage collect in the diary in the Exposure as collected (EC) domain. Any cigarette usage was reported in the SU domain, and any other nicotine replacement therapy ( patches, smokeless tobacco etc) were represented in the CM domain. The tobacco study product accountability was reported in the Product Accountability (DA) domain.  The subject were provided cartridges at each visit depending on the number of cigarettes used per day prior to study start.  Heavy smokers were provided more cartridges at each dispensing visit then other smokers. The visits were 1 week apart. The cartridge were designed to last a non-heavy smoker a day. 10 cartridges were dispensed for non-heavy smokers , and 14  cartridges were dispensed to heavy smokers. All cartridges were labeled TEST PRODUCT.    

This is an example of the subject's diary.    

This data was represented in the EC domain and Product Accountability domains.   The sponsor was only interested in the total number of cartridges used per week The investigator and the subject reviewed the diary at each visit, with the dispensed and return amount to verify the data.          

All cartridges dispensed weight  40 mg grams at the time of dispensing. The weight of each cartridge was weight at return.  The total weight used for the week was represented in EXDOSE.