Clinical Safety

Since the first approval of rFVIIa in 1996, and until April 15, 2004, approximately 550,000 standard dosages have been administered (one standard dose = one 70-kg patient administered a dose of 90 |g/kg). During this period, 14 spontaneous thromboembolic adverse events were reported in patients with inherited hemophilia A or B. There was no evidence of a dose relationship, and an alternative etiology for thrombosis was identified in the majority of cases. Accordingly, rFVIIa is considered to have a good safety profile in its labeled indication in hemophilia A or B patients with inhibitors, making it possible to proceed with further clinical development in other indications.

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