Table 4.
Predicted median time in days to reach factor VIII threshold levels of 1, 3, and 5 IU/dL after a single BAY 94-9027 dose stratified by patient age
FVIII threshold (IU/dL) | BAY 94-9027 dose (IU/kg) | Median time (5th–95th percentile) [days] | |
---|---|---|---|
Age 12 to < 18 years (n = 12) | Age ≥ 18 years (n = 133) | ||
1 | 25 | 4.3 (2.8–6.0) | 4.4 (2.8–6.7) |
35 | 4.6 (3.0–6.5) | 4.8 (3.1–7.3) | |
45 | 5.0 (3.2–6.8) | 5.0 (3.2–7.7) | |
50 | 5.0 (3.2–7.0) | 5.1 (3.3–7.8) | |
60 | 5.2 (3.4–7.3) | 5.3 (3.4–8.1) | |
3 | 25 | 3.1 (2.0–4.4) | 3.3 (2.1–5.0) |
35 | 3.5 (2.2–4.9) | 3.6 (2.3–5.5) | |
45 | 3.7 (2.4–5.2) | 3.9 (2.5–5.9) | |
50 | 3.8 (2.5–5.4) | 4.0 (2.5–6.1) | |
60 | 4.0 (2.6–5.7) | 4.2 (2.7–6.4) | |
5 | 25 | 2.6 (1.7–3.6) | 2.7 (1.7–4.2) |
35 | 2.9 (1.9–4.1) | 3.1 (1.9–4.7) | |
45 | 3.2 (2.1–4.5) | 3.4 (2.1–5.1) | |
50 | 3.3 (2.1–4.6) | 3.5 (2.2–5.3) | |
60 | 3.5 (2.3–4.9) | 3.7 (2.3–5.6) |
FVIII factor VIII