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Background  In nonvalvular atrial fibrillation ( NVAF ), rivaroxaban is used to prevent stroke and systemic embolism.    Objective  To evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real‐world clinical setting.    Methods  From January 1, 2013, to March 31, 2014,  US  Department of Defense electronic health care records were queried to describe  MB  rates and demographics. Major bleeding was identified using a validated algorithm.    Results  Of 27 467 patients receiving rivaroxaban, 496  MB  events occurred in 478 patients, an incidence of 2.86 per 100 person‐years (95% confidence interval: 2.61‐3.13). The  MB  patients were older, mean ( SD ) age of 78.4 (7.7) vs 75.7 (9.7) years, compared with non‐ MB  patients. Patients with  MB  had higher rates of hypertension (95.6% vs 75.8%), coronary artery disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%). Of  MB  patients, 63.2% were taking 20 mg, 32.2% 15 mg, and 4.6% 10 mg of rivaroxaban. Four percent of  MB  patients took warfarin within the prior 30 days. Major bleeding was most commonly gastrointestinal (88.5%) or intracranial (7.5%). Although 46.7% of  MB  patients received a transfusion, none had sufficient evidence of receiving any type of clotting factor. Fourteen died during their  MB  hospitalization, yielding a fatal bleeding incidence rate of 0.08 per 100 person‐years (95% confidence interval: 0.05‐0.14). Mean age at death was 82.4 years.    Conclusions  In this large observational study, the  MB  rate was generally consistent with the registration trial results, and fatal bleeds were rare.

Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban