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Wednesday, 07/01/2020 1:16:31 PM

Wednesday, July 01, 2020 1:16:31 PM

Post# of 233384
What is a serious adverse event?

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:

Death
Report if you suspect that the death was an outcome of the adverse event, and include the date if known.

https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
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In a blinded trial, death is reported as a serious adverse event and analysis is conducted to determine mortality rates for each treatment arm. Data is TBD.
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