Table 3.
Predicted numbers of subjects achieving factor VIII trough levels of >1% or > 3% following single or multiple doses of BAY 94-9027 or single doses of sucrose-formulated recombinant FVIII (rFVIII-FS)
Days after dosing | BAY 94-9027 |
rFVIII-FS |
||||
---|---|---|---|---|---|---|
25 IU kg−1, single dose (n = 7) | 25 IU kg−1, multiple doses (n = 7) | 60 IU kg−1, single dose (n = 7) | 60 IU kg−1, multiple doses (n = 7) | 25 IU kg−1, single dose (n = 7) | 50 IU kg−1, single dose (n = 7) | |
Subjects with FVIII trough levels of > 1%, n | ||||||
2 | 7 | 7 | 7 | 7 | 6 | 7 |
3 | 7 | 7 | 7 | 7 | 4 | 6 |
4 | 5 | 6 | 7 | 7 | 1 | 3 |
5 | 1 | 2 | 6 | 6 | 1 | 1 |
6 | 1 | 2 | 2 | 3 | 0 | 0 |
≥ 7 | 1 | 1 | 1 | 2 | 0 | 0 |
Subjects with FVIII trough levels of > 3%, n | ||||||
2 | 7 | 7 | 7 | 7 | 4 | 7 |
3 | 4 | 6 | 7 | 7 | 1 | 4 |
4 | 1 | 2 | 6 | 6 | 0 | 1 |
5 | 1 | 1 | 1 | 2 | 0 | 0 |
6 | 0 | 0 | 1 | 2 | 0 | 0 |
≥ 7 | 0 | 0 | 0 | 0 | 0 | 0 |