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.
- 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.
We would like to develop some examples to try to illustrated some common ways to provide this data that others can follow.
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.
| 1 | --TRTV | Treatment Vehicle | Char | Record Qualifier | C927 | A carrier or inert medium in which a medicinally active agent is administered. | "SALINE" |
| 1 | --VAMT | Treatment Vehicle Amount | Num | Record Qualifier | C82553 | Amount of the prepared product (treatment plus vehicle) administered. | Note: Should not be diluent amount alone. | ||||
| 2 | --VAMTU | Treatment Vehicle Amount Units | Char | Variable Qualifier | --VAMT | C82583 | The unit of measure for the prepared product (treatment plus vehicle) using standardized values. | "mL", "mg" |
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,
- 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.
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 1 container was used, or xxx.
2. IF amount of product used ( Numer of pouches, number of cigarettes, etc then we may be able to use VAMT, and Pharmaceutical strength to provide more details.
3. Some sponsor may leave these details to an ADaM datset, and provide really only collected data for the exposure.
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