A total of 63 (18%) experienced 88 thromboembolic or ischemic events. Of the 63 subjects who experienced a thrombotic event, the median time to first event was 7 days, and 21 subjects experienced the event within the first three days. The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received ANDEXXA. SELECT IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Nadir was defined as the smallest value measured within 5 minutes after the end of the continuous infusion. Primary efficacy measure: Mean percent change in anti-factor Xa (FXa) activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion. At 3 hours after the last dose, ANDEXXA or placebo was administered as a 400-mg IV bolus followed by a 4 mg/minute continuous infusion for 2 hours Healthy subjects received apixaban 5 mg twice daily for 3.5 days. In ANNEXA-A (apixaban reversal), 23/31 subjects received ANDEXXA.At 4 hours after the last dose, ANDEXXA or placebo was administered as an 800-mg IV bolus followed by an 8 mg/minute continuous infusion for 2 hours Healthy subjects received rivaroxaban 20 mg once daily for 4 days. In ANNEXA-R (rivaroxaban reversal), 26/39 subjects received ANDEXXA.Study design: ANNEXA-R and ANNEXA-A were two Phase 3 studies designed to establish the efficacy and safety of ANDEXXA for the reversal of anticoagulation with rivaroxaban or apixaban in older, healthy volunteers versus placebo.
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