Table 5.
Simulation results for percentage of patients with factor VIII levels above threshold at steady state
| Dosing frequency by age group | BAY 94-9027 dose (IU/kg) | Patients above threshold FVIII level (%) | ||
|---|---|---|---|---|
| ≥ 1 IU/dL | ≥ 3 IU/dL | ≥ 5 IU/dL | ||
| Once weekly | ||||
| 12 to < 18 years | 60 | 11.3 | 1.4 | 0.6 |
| ≥ 18 years | 60 | 18.6 | 5.5 | 2.9 |
| Twice weekly | ||||
| 12 to < 18 years | 25 | 60.1 | 19.8 | 7.6 |
| 30 | 66.9 | 25.5 | 10.4 | |
| 40 | 74.9 | 36.8 | 18.6 | |
| ≥ 18 years | 25 | 60.2 | 27.6 | 13.8 |
| 30 | 63.9 | 33.0 | 18.1 | |
| 40 | 70.4 | 41.2 | 27.0 | |
| Every 5 days | ||||
| 12 to < 18 years | 45 | 45.6 | 13.3 | 4.5 |
| 50 | 48.5 | 15.3 | 6.1 | |
| 60 | 55.3 | 20.3 | 8.8 | |
| ≥ 18 years | 45 | 47.9 | 20.8 | 10.0 |
| 50 | 51.8 | 23.4 | 12.4 | |
| 60 | 56.2 | 27.6 | 15.5 | |
FVIII factor VIII