The following example shows subjects who applied a lotion once per day, for a blinded study. The treatment was supplied as identical single-use containers, each of which held 1 day's worth of medication. The sponsor collected drug accountability and exposure information at each visit. The drug accountability data collected were represented in the DA domain and the collected exposure information in the EC domain. In this example, the volume remaining in the opened containers was not required to be collected.
Shows that at the first visit on day 1, 15 containers of study product were dispensed to the subject.
|Row 2:||Shows that at the second visit on day 15, 1 container of unopened study product was returned by the subject.|
|Row 3:||Shows that at the second visit on day 15, 14 containers of opened study product were returned by the subject.|
Shows that at the second visit on day 15, 15 additional containers of study product were dispensed to the subject.
|Row 5:||Shows that at the third visit on day 30, 2 containers of unopened study product were returned by the subject.|
|Row 6:||Shows that at the third visit on day 30, 13 containers of opened study product were returned by the subject.|
|1||PS012||DA||101||1||1||DISPAMT||Dispensed Amount||Study Product||15||CONTAINER||15||15|
|2||PS012||DA||101||2||1||RETAMT||Returned Amount||Unopened Study Product||1||CONTAINER||1||1||CONTAINER||2||2012-05-15||15|
|3||PS012||DA||101||3||1||RETAMT||Returned Amount||Opened Study Product||14||CONTAINER||14||14||CONTAINER||2||2012-05-15||15|
|4||PS012||DA||101||4||2||DISPAMT||Dispensed Amount||Study Product||15||CONTAINER||15||15|
|5||PS012||DA||101||5||2||RETAMT||Returned Amount||Unopened Study Product||2||CONTAINER||2||2||CONTAINER||3||2012-05-30||30|
|6||PS012||DA||101||6||2||RETAMT||Returned Amount||Opened Study Product||13||CONTAINER||13||13||CONTAINER||3||2012-05-30||30|
The sponsor used a CRF that was designed as a log form to collect exposure information. This data was then represented in the EC domain. The record qualifier ECOCCUR was used to represent whether an application occurred. An ECOCCUR value of "N" indicates an application was not applied, not given, or missed.
|Row 1:||Shows consecutive daily treatment applications.|
|Row 2:||Shows that subject 101 missed a day of application, represented as ECOCCUR="N".|
|Row 3:||Shows that subject 101 resumed applying the treatment on day 12 (ECOCCUR="Y") and finished the treatment on day 15.|
|Rows 4-8:||Show the daily treatment applications for subject 102, including missed days.|
The Exposure (EX) domain is a derived dataset where the data reflects the protocol-specified unit per study treatment based on the collected data (dispensing and exposure) and additional input from the protocol and randomization data. In this example, the containers have either 0.25 mg/g of drug X or 0.5 mg/g of drug Y. Because the weight of the tubes returned was not collected, the sponsor reported the dosage using application units. The concentration of the lotion was represented in EXPSTRG and EXPSTRGU. The sponsor used an ADaM dataset to provide more information on exposure; a study-specific algorithm was used to estimate exposure based on the number of used containers. This algorithm provided rules for exposure estimation when the drug accountability data were incomplete or missing. An example ADaM exposure dataset is provided in Section 7, Analysis Data.
|Rows 1-2:||Show the exposure for subject 101. This subject did not apply any drug on day 11. The dataset does not contain information on medications not taken, not given, or missed.|
|Rows 3-5:||Show the exposure for subject 102. This subject did not apply any drug on days 9 and 13.|