SAFETY PROFILE
In the UNIVERSE clinical trial A comparable prevalence of overall bleeding events was observed with XARELTO® versus aspirin1
Bleeding events were comparable across treatment groups1,2*
Major Bleed: single case of epistaxis (nosebleed) occurred in the rivaroxaban part B group.
Trivial bleeds: most frequent site of trivial bleeding was the skin in both groups.
Clinically relevant nonmajor bleeds: with rivaroxaban, bleeding events occurred in the lower GI tract, gingival tissue, and skin; with ASA, these events occurred in the lower GI tract, skin, hematoma, and subconjunctival tissue.
Not powered to test formal hypotheses for efficacy and safety due to the limited availability of the study population and the expected low event rates.2,3
*Clinically relevant nonmajor bleeding is clinically overt bleeding, which did not meet the criteria for major bleeding, but was associated with medical intervention, unscheduled contact with a physician, temporary cessation of treatment, discomfort for the patient, or impairment of activities of daily life. Major bleeding is clinically overt bleeding associated with a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.
ASA = aspirin; GI = gastrointestinal.