Treatment Dispensed and Returned

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.

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.

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.