The Adverse Events dataset includes clinical data describing "any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment" (ICH E2A).
In consultation with regulatory authorities, sponsors may extend or limit the scope of adverse event collection (e.g., collecting pre-treatment events related to trial conduct, not collecting events that are assessed as efficacy endpoints).
The events included in the AE dataset should be consistent with the protocol requirements.
Adverse events may be captured either as free text or via a pre-specified list of terms.