ROCKET AF Results - cardiomil.com.uy

Statistical Methodologies Sample Size• Warfarin event rate ~2.3• Type 1 error 0.05 (2-sided)• 405 events; >95% powerSuperiorityNon-inferiorityInferiorityRivaroxabanBetter1.0 1.46WarfarinBetter• ~14,000 patients Primary Efficacy Evaluation: Stroke or non-CNS Embolism• Non-Inferiority: Protocol Compliant on treatment• Superiority: On Treatment and then by Intention-to-Treat Primary Safety Evaluation: Major or non-Major ClinicallyRelevant Bleeding