Results from an ongoing 5-year post-marketing study evaluating the safety of Xarelto (rivaroxaban; Janssen) show that rates and patterns of major bleeding in clinical practice are overall consistent with those seen in Phase 3 clinical trials used to approve the medicine.

Researchers reported that these results at 15 months support the safety profile of Xarelto. Data from January 1, 2013 to March 31, 2014 were analyzed to examine major bleeding rates in 27,467 nonvalvular atrial fibrillation (NVAF) patients treated with Xarelto. Major bleeding was observed at 2.86 person-years, which was consistent with incidence rates reported in the ROCKET-AF clinical trial. Older patients (mean age 78) experienced more bleeding and fatal outcomes were rare.

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As part of the Xarelto clinical development program, Janssen is conducting several post-marketing surveillance studies to further evaluate the benefit-risk profile of Xarelto in real-world settings. By July 2015, the following studies will have been included in the Phase 4 observational program across 6 approved indications:

  • XAMOS: a non-interventional Phase 4 study (n=17,700) that showed lower rate of venous thromboembolism (VTE) after major orthopedic surgery
  • XALIA: a multi-center, prospective, non-interventional, observational study (n>4,800) for Xarelto monotherapy in acute VTE treatment
  • XANTUS: a prospective, international, observational, post-authorization, non-interventional study (n=6,000) for stroke prevention
  • GARFIELD AF: an observational, multi-center registry of newly diagnosed atrial fibrillation (AFib) patients (n=56,500)
  • GARFIELD VTE: an observational, multi-center registry evaluating long-term management and outcomes of VTE (n=10,000)
  • ORBIT-AF: a multi-center, prospective, outpatient disease registry to identify real-world treatment patterns of AFib (n=10,000)

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