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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 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.
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
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This EX dataset attempts to provide all the basic information.
For example- SDTM has variables like
| 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" |
In this dataset , I showed all three data points-
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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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