Table 4.

Efficacy of treatment of bleeding episodes in the pivotal study

	Treatment of bleeding episodes (N = 518*)
Number of infusions to treat bleeding episodes, n (%)
1 infusion	443 (85.5)
2 infusions	54 (10.4)
Total (1 or 2 infusions)	497 (95.9)
Median (Q1 ; Q3) dose per infusion to treat a bleeding episode, IU/kg
All bleeds/severities (N = 518)	29.0 (20.0; 39.2) IU/kg
Minor (N = 245)	25.5 (16.9;37.6) IU/kg
Moderate (N = 238)	30.9 (23.0; 43.1) IU/kg
Severe/major (N = 35)	36.4 (29.0; 44.5) IU/kg
Hemostatic efficacy rating, n (%)
Excellent or good	498 (96.1)
Infusions to treat a bleeding episode mean
Number of infusions (SD)	1.2 (0.7)

^*PPAS for patients in prophylaxis and on-demand groups (N = 118). For PPAS criteria, refer to Table 1.