Furthermore, data relating to all suspected events were examined by the same ad hoc medical committee.
Information from medical records was extracted onto standard forms for classifying suspected events according to protocol.
After those suspected events were collected, physician reviewers independently evaluated them and classified them as operation-related MEs, AEs, or rule violations.
Of these suspected events, 10.2 % were confirmed by the adjudication committee in the rivaroxaban group compared with 9.7%% in the standard-of-care group.
A medical committee comprising one member of each PRIME centre, the coordinating centre, and three independent cardiologists was established to examine medical data relating to all suspected events.
Of these suspected events, all of which were confirmed by the adjudication committee, 15.7 % were in the rivaroxaban group and 23.7 % occurred in the standard-of-care group.
An independent external clinical event committee reviewed treatment-emergent fatal events and suspected events of stroke, myocardial ischaemia (including myocardial infarction), hospitalization for heart failure, stent thrombosis and revascularization procedures.
An independent external adjudication committee reviewed treatment-emergent fatal events and suspected events of stroke or cardiac ischemia (including myocardial infarction), hospitalization for heart failure, stent thrombosis, and revascularization procedures.
As the basis for detection of suspected events related to substandard medicines, we used the previously developed algorithm [ 5] for identifying groups of reports on a drug with a higher than expected relative frequency of product inadequacy.
