Exposure
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Exposure
The Exposure domain model records the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject.
| Variables | Data Type | Question | Code List | Validation |
|---|---|---|---|---|
| exyn | radio | Is treatment data available? | ny | |
| exstdat | text | What was the treatment start date? | date_dmy | |
| exsttim | text | What was the treatment start time? | time | |
| exrefid | text | What is the treatment label identifier? | ||
| exendat | text | What was the treatment end date? | date_dmy | |
| exentim | text | What was the treatment end time? | time | |
| epoch | dropdown | To which period of the trial does this exposure refer? | epoch | |
| exdstxt | text | What was the dose per administration? (text) | ||
| exdose | text | What was the dose per administration? (numeric) | number | |
| exdosu | dropdown | What were the units for the dose? | exdosu | |
| exfast | radio | Fasting Status | ny | |
| exlot | text | What was the lot number of the study treatment used? | ||
| extrt | text | Study Treatment Name | ||
| exdosadj | radio | Was the dose adjusted from planned? | ny | |
| exadj | notes | What was the reason the dose was adjusted? | ||
| exdosfrq | dropdown | What was the frequency of study treatment dosing? | exdosfrq | autocomplete |
| exroute | dropdown | What was the route of administration for the study treatment? | exroute | autocomplete |
| exdosfrm | dropdown | What was the formulation of the study treatment? | exdosfrm | autocomplete |
| exintrp | text | If the dose was interrupted, how long was the interruption? | ||
| exintrpu | dropdown | If the dose was interrupted, what were the units for the duration? | exdosu | autocomplete |
| exloc | dropdown | What was the anatomical location of the administration? | loc | autocomplete |
| exlat | dropdown | What was the Laterality of the administration? | lat | autocomplete |
| exdir | dropdown | What was the Directionality of the dose administered? | dir | autocomplete |
| exvamt | text | What was the total volume of study treatment administered? | ||
| exvamtu | dropdown | What were the units for the volume of study treatment administered? | unit | autocomplete |
| exflrt | text | What was the study treatment infusion rate? | number | |
| exflrtu | dropdown | What were the units for the infusion rate? | unit | autocomplete |
| extpt | dropdown | What was the planned time point for study treatment? | autocomplete | |
| extrtcmp | radio | Did subject complete the full course of study treatment? | ny | |
| expdose | text | What was the planned dose per administration? (numeric) | ||
| expdosu | dropdown | What were the units for the planned dose? | unit | autocomplete |
| expoccur | radio | Was the planned dose administered? | ny |