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Kaufman KD, Olsen EA, Whiting D, et al
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While Balfaxar met the primary endpoint of hemostatic efficacy in a Phase III study and was non-inferior to the comparator, Kcentra, fatal and non-fatal arterial and venous thromboembolic complications were observed in clinical trials and post-marketing studies, and healthcare providers are advised to monitor patients for signs of thromboembolic events
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