Summary of rFVIIIFc TEAEs by treatment regimen in the safety analysis set
| . | Treatment regimen . | |
|---|---|---|
| While OD (n = 81) . | While on prophylaxis (n = 89) . | |
| Total number of TEAEs | 308 | 683 |
| Subjects with ≥1 TEAE, n (%) | 71 (87.7) | 75 (84.3) |
| Subjects with ≥1 related TEAE, n (%)* | 6 (7.4) | 22 (24.7) |
| Subjects who discontinued treatment and/or study owing to TEAE, n (%) | 3 (3.7) | 1 (1.1) |
| Total number of TESAEs | 60 | 71 |
| Subjects with ≥1 TESAE, n (%) | 38 (46.9) | 34 (38.2) |
| Subjects with ≥1 related TESAE, n (%)* | 6 (7.4) | 22 (24.7) |
| Deaths, n (%)† | 0 (0.0) | 0 (0.0) |
| . | Treatment regimen . | |
|---|---|---|
| While OD (n = 81) . | While on prophylaxis (n = 89) . | |
| Total number of TEAEs | 308 | 683 |
| Subjects with ≥1 TEAE, n (%) | 71 (87.7) | 75 (84.3) |
| Subjects with ≥1 related TEAE, n (%)* | 6 (7.4) | 22 (24.7) |
| Subjects who discontinued treatment and/or study owing to TEAE, n (%) | 3 (3.7) | 1 (1.1) |
| Total number of TESAEs | 60 | 71 |
| Subjects with ≥1 TESAE, n (%) | 38 (46.9) | 34 (38.2) |
| Subjects with ≥1 related TESAE, n (%)* | 6 (7.4) | 22 (24.7) |
| Deaths, n (%)† | 0 (0.0) | 0 (0.0) |
Safety analysis set (n = 103). Subjects may appear in >1 treatment regimen. Percentages are based on the number of subjects in each treatment regimen.
TESAE, treatment-emergent serious adverse event.
Those AEs with an undefined relationship were included with related AEs.
Death due to an intracranial hemorrhage with onset during the screening period before the first dose of rFVIIIFc; the subject received 1 administration of rFVIIIFc for this hemorrhage before he died.