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The PMTA rule defines adverse experiences in tobacco product studies, whereas clinical trials use the term "adverse events". Some of the procedures in the collection of adverse experiences in tobacco product studies follow the conventions used for collecting adverse events (e.g., coding dictionaries, definition of severity). Thus, the term "adverse event" may be used as a synonym for "adverse experiences" in this document. |
The Adverse Events (AE) domain is based on the Events General Observation class. In tobacco product studies, the Adverse Events (AE) domain is used for representing adverse experiences. The Food and Drug Administration in the premarket tobacco product applications (PMTA) Rule defines “adverse experience” as FDA's 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 exposure experiences related to trial conduct, not collecting events that are assessed as efficacy study 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.
For the purposes of this section, the terminology "adverse event" is used.
Adverse event terms It is the applicant's responsibility to define an event and the appropriate collection period for events. This definition may vary based on product characterization and reporting of product safety. In consultation with regulatory authorities, applicants may extend or limit the scope of event collection. Adverse events may be captured either as free text or via a prespecified list of terms.
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This is an example of a CRF used to collect all adverse events experiences that occurred after informed consent is was obtained. Adverse events experiences were collected using free - text. This The CRF was designed to allow the applicant to use either AEENRF or AEENRTPT to represent an event that was ongoing.
This SDTM dataset illustrates data collected on the example AE CRF above. This SDTM dataset used AENRTPT. More For more information can be found in , see Section 2.8.7.6, Representing References and Relative Timing.
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