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) |
| . | 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.