EX/EC Exposure Example 2

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

2. 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 nicotine.  What should be reported????  We do not really have the real exposue...