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Adverse Event Relationship to Non Study Treatment
An indication or description of the relationship of an adverse event to a non-study treatment. (NCI Thesaurus)
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A character or string used to name, or characterize an adverse event reference.
An indication or description that an adverse event was previously determined, characterized, or detailed.
The date (and time) on which the adverse event was updated after it had been submitted.
The pattern of an adverse event.
An assessment result of the final state in a person who experienced an adverse event, which takes place after the adverse event…
Terminology used in Individual Case Safety Reports for description of adverse event outcomes, section B2 of FDA MedWatch Form.