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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.
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.
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.
Similar(48)
All 60 cases of medically diagnosed concussion are included in the analysis, along with the 96 cases where the CIR was used but the athlete was not diagnosed with a concussion following the suspected event.
In case of a suspected event, we collected clinical notes and the results of diagnostic tests for adjudication.
Therefore, it becomes difficult to determine whether a suspected event in the same leg or pulmonary vein is new or residual thrombosis from the index event.
Follow-up was per normal clinical practice and subjects were advised to contact the treating physician promptly in the case of a suspected event.
When a suspected event occurred, all relevant records, including the results of diagnostic tests and procedures (imaging, endoscopy, cytology, biopsy, surgery, etc).
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