As It was explained to me...
Adverse Events are complications, or conditions (events) which would not be considered part of the normal disease progression for the indication the trial is studying...
R-I is concerned with CVD so death from cancer would not be part of the expected progress, death from an MI would be..Also included would be allergies..other disease conditions, UTIs, arthritis, GI conditions...ie events related to conditions other than CVD,,,,
The regulatory process is the attending study physicians report the event to the CRO which has the patient codes...The CRO then reports the AE to the sponsor (Amarin), unblinded, and the Amarin reports the AE to the FDA within a very short time period...
":>) JL
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