anticipated adverse event
Glossaries
| Term | Definition |
|---|---|
| anticipated adverse event |
Other adverse events that are not study endpoints and are not "expected" (i.e., because they are not in the investigator's brochure) that can be anticipated to occur with some frequency during the course of the trial, regardless of drug exposure, depending on the patient population and disease under study. NOTE: Examples of such "anticipated" events include known consequences of the underlying disease or condition under investigation, events anticipated from any background regimen, or re-emergence or worsening of a condition relative to pretreatment baseline. [after FDA, Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies]
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