DEFINITION : The Adverse Events (AE) domain captures details about any untoward medical occurrences experienced by the subject during the clinical trial, regardless of whether it is related to the study treatment.  

PURPOSE : To track and document any adverse effects experienced by subjects to assess safety and risk of the investigational product

STRUCTURE : One record per adverse event per subject

TOPIC : AETERM

KEY VARIABLES : STUDYID, USUBJID, AEDECOD, AESTDTC