What is an adverse event (AE)?
An adverse event (AE) is defined as any occurrence that has unfavorable and/or unintended effects on research subjects, regardless of severity or study-relatedness. AEs may manifest as new findings (signs, symptoms, diagnoses, laboratory results) or alterations in pre-existing conditions. AEs must be monitored throughout the entire course of a study, as well as during a reasonable follow-up period after study completion.
