Table 4.
Median time to FVIII threshold level after a single intravenous dose (simulation of 1000 patients)
| Dose, IU/kg | Threshold level, IU/dL | BAY 81-8973, h (5th and 95th Percentiles) | rAHF-PFM, h (5th and 95th Percentiles) | Ratioa | Differenceb, h |
|---|---|---|---|---|---|
| 25 | 1 | 80.5 (50.5; 122.5) | 62.5 (39.5; 100) | 1.29 | 18 |
| 25 | 3 | 59 (36.5; 90) | 43.5 (26.5; 71) | 1.36 | 15.5 |
| 25 | 5 | 49 (30; 74.5) | 34.5 (24; 57) | 1.42 | 14.5 |
| 25 | 10 | 34.5 (24; 53) | 24 (15; 39) | 1.44 | 10.5 |
| 30 | 1 | 84.5 (53; 128) | 65.5 (42; 104.5) | 1.29 | 19 |
| 30 | 3 | 63 (38.5; 95.5) | 46.5 (28.5; 75.5) | 1.35 | 16.5 |
| 30 | 5 | 52.5 (32.5; 80) | 38 (24; 62) | 1.38 | 14.5 |
| 30 | 10 | 38.5 (24; 58.5) | 26 (15; 43.5) | 1.48 | 12.5 |
| 40 | 1 | 90 (56.5; 136.5) | 71 (45.5; 112.5) | 1.27 | 19 |
| 40 | 3 | 68.5 (42.5; 104) | 51.5 (32; 83.5) | 1.33 | 17 |
| 40 | 5 | 58.5 (36; 89) | 43 (26; 70) | 1.36 | 15.5 |
| 40 | 10 | 44.5 (27; 67.5) | 31 (24; 51) | 1.44 | 13.5 |
| 50 | 1 | 94.5 (59.5; 143.5) | 74.5 (48; 118.5) | 1.27 | 20 |
| 50 | 3 | 73 (45; 110.5) | 55.5 (34.5; 89) | 1.32 | 17.5 |
| 50 | 5 | 63 (38.5; 95.5) | 46.5 (28.5; 75.5) | 1.35 | 16.5 |
| 50 | 10 | 49 (30; 74.5) | 34.5 (24; 57) | 1.42 | 14.5 |
FVIII factor VIII, rAHF-PFM antihemophilic factor (recombinant) plasma/albumin-free method
aRatio of BAY 81-8973:rAHF-PFM
bDifference of BAY 81-8973 − rAHF-PFM