Male patients with congenital hemophilia with inhibitors who experienced spontaneous bleeding were eligible for this observational study if they required treatment with bypassing agents for at least four bleeding episodes of any type in the prior 3 months and were prescribed recombinant activated factor VII as first-line therapy for bleeding episodes (including breakthrough bleeding with prophylaxis and immune tolerance therapy [ITT]). Patients were categorized as on-demand treatment for bleeding (OD), secondary prophylaxis with bypassing agent (PPX), and/or ITT. Subjects received standard care according to local practice, and treatment decisions were made by the health care provider. Patients and caregivers were encouraged to communicate in a standard fashion with their treatment center during the study and to not share any diary materials or treatment logs that would not otherwise have been provided to their HTC.