Table 5.

Patients with serious and non-serious adverse events (Intent to treat population)

	Non-serious adverse event	Related non-serious adverse event	SAE	Related SAE	Deathsa
Congenital hemophilia (N = 71)
Patients on prophylaxis	17	2	8	0	0
Patients on on-demand	17	1	15	1b	1
Patients on unknown regimen	8	0	1	0	0
Acquired hemophilia (N = 10)
Patients on prophylaxis	0	0	0	0	0
Patients on on-demand	7	2	7	2c	2
Patients on unknown regimen	5	0	4	0	0

SAE, serious adverse event.

^aAll deaths were considered unrelated to study drug. Related serious adverse events: ^bhemarthrosis, ^ccatheter-related infection, ^cthrombophlebitis superficial. An 86-year-old woman with AHA developed superficial thrombophlebitis and DVT following co-administration of rFVIIa and FEIBA during the course of the study. Related nonserious adverse events: nausea; allergic pruritus; prolonged prothrombin time; lymphopenia; constipation; pneumonia; hemarthrosis. Note: Patients may have had events in different categories. Therefore, the numbers may not add up to the total. Adverse events with missing seriousness were counted as serious (worst case assumption).