All intercurrent bleeding by treatment arm and phase of ITI
| . | Regimen . | Bleeds, n . | HR . | 95% CI . | P . |
|---|---|---|---|---|---|
| All ITI (n = 58 vs 57) | LD | 684 | 2.2 | 1.34-3.62 | .0019 |
| HD | 282 | ||||
| Phase 1 (n = 58 vs 57) | LD | 573 | 2.27 | 1.29-4.01 | .0046 |
| HD | 241 | ||||
| Phase 2 (n = 27 vs 23) | LD | 47 | 3.4 | 0.84-13.8 | .088 |
| HD | 4 | ||||
| Phase 3 (n = 24 vs 22) | LD | 9 | 5.18 | 0.71-38.0 | .110 |
| HD | 3 | ||||
| Phase 4 (n = 24 vs 22) | LD | 54 | 1.70 | 0.80-3.63 | .170 |
| HD | 32 |
| . | Regimen . | Bleeds, n . | HR . | 95% CI . | P . |
|---|---|---|---|---|---|
| All ITI (n = 58 vs 57) | LD | 684 | 2.2 | 1.34-3.62 | .0019 |
| HD | 282 | ||||
| Phase 1 (n = 58 vs 57) | LD | 573 | 2.27 | 1.29-4.01 | .0046 |
| HD | 241 | ||||
| Phase 2 (n = 27 vs 23) | LD | 47 | 3.4 | 0.84-13.8 | .088 |
| HD | 4 | ||||
| Phase 3 (n = 24 vs 22) | LD | 9 | 5.18 | 0.71-38.0 | .110 |
| HD | 3 | ||||
| Phase 4 (n = 24 vs 22) | LD | 54 | 1.70 | 0.80-3.63 | .170 |
| HD | 32 |
Phase 1 indicates the time from the start of ITI until the Bethesda titer is negative; phase 2, from phase 1 until the FVIII recovery is normal; phase 3, from phase 2 to normal half-life; and phase 4, 12-month prophylactic phase after the half-life has normalized.