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The Adverse Events (AE) domain is based on the Events General Observation class. The In tobacco product studies, AE domain is used to represent 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: https://www.fda.gov/regulatory-information). In is used for representing adverse experiences. The Food and Drug Administration in the premarket tobacco product applications (PMTA) Rule 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. In consultation with regulatory authorities, applicants 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.. For  For the purposes of this section, the terminology "adverse event" is used.

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