Summary of prescribed dose and frequency at end of efficacy period, arm 1 (n = 117)
| . | Dosing frequency, n (%)* . | ||||
|---|---|---|---|---|---|
| rFVIIIFc dose, IU/kg . | Twice weekly . | Every 3 d . | Every 4 d . | Every 5 d . | Total . |
| 25 | 0 (0) | 3 (2.6) | 0 (0) | 0 (0) | 3 (2.6) |
| 30 | 0 (0) | 2 (1.7) | 0 (0) | 0 (0) | 2 (1.7) |
| 35 | 0 (0) | 1 (0.9) | 0 (0) | 0 (0) | 1 (0.9) |
| 25/50† | 34 (29.1) | 0 (0) | 0 (0) | 0 (0) | 34 (29.1) |
| 40 | 0 (0) | 2 (1.7) | 0 (0) | 0 (0) | 2 (1.7) |
| 45 | 1 (0.9) | 0 (0) | 0 (0) | 0 (0) | 1 (0.9) |
| 50 | 0 (0) | 20 (17.1) | 2 (1.7) | 34 (29.1) | 56 (47.9) |
| 60 | 0 (0) | 1 (0.9) | 0 (0) | 1 (0.9) | 2 (1.7) |
| 65 | 0 (0) | 10 (8.5) | 2 (1.7) | 4 (3.4) | 16 (13.7) |
| Total | 35 (29.9) | 39 (33.3) | 4 (3.4) | 39 (33.3) | 117 (100) |
| . | Dosing frequency, n (%)* . | ||||
|---|---|---|---|---|---|
| rFVIIIFc dose, IU/kg . | Twice weekly . | Every 3 d . | Every 4 d . | Every 5 d . | Total . |
| 25 | 0 (0) | 3 (2.6) | 0 (0) | 0 (0) | 3 (2.6) |
| 30 | 0 (0) | 2 (1.7) | 0 (0) | 0 (0) | 2 (1.7) |
| 35 | 0 (0) | 1 (0.9) | 0 (0) | 0 (0) | 1 (0.9) |
| 25/50† | 34 (29.1) | 0 (0) | 0 (0) | 0 (0) | 34 (29.1) |
| 40 | 0 (0) | 2 (1.7) | 0 (0) | 0 (0) | 2 (1.7) |
| 45 | 1 (0.9) | 0 (0) | 0 (0) | 0 (0) | 1 (0.9) |
| 50 | 0 (0) | 20 (17.1) | 2 (1.7) | 34 (29.1) | 56 (47.9) |
| 60 | 0 (0) | 1 (0.9) | 0 (0) | 1 (0.9) | 2 (1.7) |
| 65 | 0 (0) | 10 (8.5) | 2 (1.7) | 4 (3.4) | 16 (13.7) |
| Total | 35 (29.9) | 39 (33.3) | 4 (3.4) | 39 (33.3) | 117 (100) |
The median dosing interval among subjects on study for at least 6 months was 3.5 (range, 2.9-5.7) days when averaged over all dosing intervals during the respective time intervals for the last 3 months on the study.
Initial twice-weekly dosing regimen of 25 IU/kg on day 1, followed by 50 IU/kg on day 4.