Table 3.
Bleeding rates in patients switching to a 21-day regimen.
| Regimen | On demand (N = 5) | 7-day regimen (N = 11) | 14-day regimen (N = 11) | 21-day regimen (N = 11) |
|---|---|---|---|---|
| AsBR | ||||
| Mean (SD) | 13.89 (7.86) | 0.14 (0.477) | 0.23 (0.596) | 0.60 (1.408) |
| Median (range) | 15.63 (11.7-16.7) | 0.0 (0.0-1.6) | 0.0 (0.0-2.0) | 0.0 (0.0-4.7) |
| Patients with 0 spontaneous bleeds, n (%) | 0 (0) | 8 (73) | 6 (55) | 7 (64) |
| ABR | ||||
| Mean (SD) | 16.17 (8.98) | 0.52 (0.78) | 0.44 (0.79) | 1.19 (1.57) |
| Median (range) | 17.58 (2.0-27.0) | 0.00 (0.0-1.9) | 0.00 (0.0-2.0) | 0.32 (0.0-4.7) |
| Prophylaxis compliance (%) | ||||
| Mean (SD) | 94.7 (10.65)a | 95.0b (6.32) | 98.3 (3.79) | 96.1 (5.61) |
ABR, annualized bleed rate; AsBR, annualized spontaneous bleed rate.
a
Compliance in the on-demand group refers to the 5 patients who were previously treated on demand but then switched to prophylaxis during the phase III study.
b
Data based on 4 patients from the phase III study.