Frequency of bleeding episodes
| Parameter . | Cohort 1 (n = 2) . | Cohort 2 (n = 2) . | Cohort 3 (n = 2) . | Cohort 4 (n = 5) . | Total (n = 11) . |
|---|---|---|---|---|---|
| Experienced bleeds after study drug infusion, n (%)∗ | 2 (100) | 2 (100) | 1 (50) | 2 (40) | 7 (64) |
| Preinfusion total ABR†, mean (SD) | 3.5 (0.7) | 14.0 (17.0) | 1.5 (2.1) | 8.8 (8.3) | 7.5 (8.8) |
| Postinfusion total ABR before reinitiation of prophylaxis: all episodes‡, mean (SD) | 7.7 (3.0) | 2.3 (1.3) | 3.1 (4.4) | 0.7 (1.4) | 2.7 (3.3) |
| Parameter . | Cohort 1 (n = 2) . | Cohort 2 (n = 2) . | Cohort 3 (n = 2) . | Cohort 4 (n = 5) . | Total (n = 11) . |
|---|---|---|---|---|---|
| Experienced bleeds after study drug infusion, n (%)∗ | 2 (100) | 2 (100) | 1 (50) | 2 (40) | 7 (64) |
| Preinfusion total ABR†, mean (SD) | 3.5 (0.7) | 14.0 (17.0) | 1.5 (2.1) | 8.8 (8.3) | 7.5 (8.8) |
| Postinfusion total ABR before reinitiation of prophylaxis: all episodes‡, mean (SD) | 7.7 (3.0) | 2.3 (1.3) | 3.1 (4.4) | 0.7 (1.4) | 2.7 (3.3) |
n indicates number of participants with bleeding events.
Defined as the number of bleeding episodes during the 12 months before screening.
Postinfusion rate = (number of bleed episodes starting 3 weeks after study drug infusion and until the start of prophylactic dosing of FVIII [or date of data cut or conclusion date]) / (observation period for the participant, in years).