DEFINITION :  The Clinical Events (CE) domain captures medically important events that occur during the study, which may or may not be adverse events. These events could be related to the study treatment or other clinical factors.

PURPOSE : To record significant clinical events that impact the subject’s health during the study, whether related to treatment or not.

STRUCTURE : One record per event per subject

TOPIC : CETERM

KEY VARIABLES : STUDYID, USUBJID, CETERM, CESTDTC