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Safety Profile | Stroke Risk Reduction in NVAF | Pradaxa® (dabigatran etexilate) Skip to main content

HR=hazard ratio; CI=confidence interval

*Patients during treatment or within 2 days of stopping study treatment. Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events in multiple subcategories.
Annual event rate per 100 pt‑years = 100 * number of subjects with event/subject‑years. Subject‑years is defined as cumulative number of days from first drug intake to event date, date of last drug intake + 2, death date (whatever occurred first) across all treated subjects divided by 365.25. In case of recurrent events of the same category, the first event was considered.
On‑treatment analysis based on the safety population, compared to ITT analysis.
§Patients during treatment or within 6 days of stopping study treatment.

  • References:
  • 1. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.
  • 2. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.
  • 3. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L; for the Randomized Evaluation of Long‑Term Anticoagulation Therapy Investigators. Newly identified events in the RE‑LY Trial [Letter to the Editor]. N Engl J Med. 2010;363(19):1875‑1876.
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  • 5. Connolly SJ, Wallentin L, Ezekowitz MD, et al. The long‑term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY‑ABLE) study. Circulation. 2013;128(3):237‑243.
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  • 8. Villines TC, Schnee J, Fraeman K, et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114(6):1290-1298.
  • 9. Seeger JD, Bykov K, Bartels DB, et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015;114(6):1277-1289.
  • 10. Bridges FM, Spence M, Niu F, et al. Poster: Comparative effectiveness and safety of warfarin and dabigatran for the management of atrial fibrillation in an integrated healthcare delivery system. Month 2016.