Illustrates Domains
CM
Illustrates Variables
CMSTRF
CMENRF
CMREASOC
CMRRGYN
CMRRGREA
Content
Data on background treatment is represented in the Concomitant/Prior Medications (CM) domain.
- NSCM.CMREASOC was used to represent the reason why the medication class was not taken. In this study, the sponsor included the reason CONTRAINDICATION, but did not collect the specific contraindication.
- Because CMTRT is a required variable, the sponsor populated the variable with the specific name or class of the medication, coded using a standard dictionary. Although the coding variables are not shown here, CMCLAS and CMCLASCD may be used to indicate the drug class. CMDECOD would contain the standardized or dictionary-derived text description for CMTRT. If CMTRT does not have a decode value in the dictionary, then CMDECOD will be left blank. In this case, the sponsor did not ask the investigator to specify the medication class for each medication taken.
- CMDTC was only included by the sponsor for general questions about the use of each class of medication at baseline. The collection date provides a time-frame reference for the observation. This time-frame reference is not relevant for the observation for each specific medication used, as the actual start and end dates are collected.