Concomitant Medications(CM) :

DEFINITION : The Concomitant Medications (CM) domain captures information about medications that subjects are taking concurrently with the study treatment but are not part of the study protocol.

PURPOSE : To record additional medications that might impact the subject’s health or interact with the study drug.

STRUCTURE : One record per recorded medication occurrence or constant-dosing interval per subject.

TOPIC : CMTRT

KEY VARIABLES : STUDYID, USUBJID, CMTRT, CMSTDTC