Adverse Events

The SDTM AE domain 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). Events included in the AE domain should be consistent with protocol requirements. Adverse event terms may be captured either as free text or via a prespecified list of terms.

The Food and Drug Administration in the premarket tobacco product applications (PMTAs) defines “adverse experience” as any unfavorable physical or psychological effect in a person that is temporally associated with the use of or exposure to a tobacco product, whether or not the person uses the tobacco product, and whether or not the effect is considered to be related to the use of or exposure to the tobacco product..

Adverse event terms may be captured either as free text or via a prespecified list of terms.

This is an example of a CRF used to collect all adverse experiences that occurred after informed consent is obtained. Adverse experiences were collected using free-text. This CRF was designed to allow the sponsor to use either AEENRF or AEENRTPT to represent an event that was ongoing.