AE stands for an adverse event. This constitutes any untoward medical occurrence in a trial subject. Adverse events can be mild, moderate or severe and may be caused by other factors than the treatment used. In diagnostic device performance evaluation, an adverse event can also involve inappropriate patient management decisions, as well as unintentional disease, injury or adverse clinical signs in trial subjects.

An adverse device effect is a similar term used in performance evaluation of in vitro diagnostics medical devices, referring to an event related to the use of a diagnostic medical device, resulting from misuse or intended improper use.


What is SAE?

SAE stands for a serious adverse event. This adverse event can lead to death or serious deterioration in the health of the subject.