Summary of TEAEs by hemophilia type
| . | HA concizumab (N = 36) . | HAwI concizumab (N = 9) . | HBwI concizumab (N = 8) . | HAwI/HBwI rFVIIa on demand (N = 9) . | ||||
|---|---|---|---|---|---|---|---|---|
| n (%) . | E [R] . | n (%) . | E [R] . | n (%) . | E [R] . | n (%) . | E [R] . | |
| Exposure time, y | 17.2 | 6.1 | 5.6 | 3.9 | ||||
| All AEs | 29 (80.6) | 130 [7.6] | 7 (77.8) | 20 [3.3] | 6 (75.0) | 23 [4.1] | 7 (77.8) | 18 [4.7] |
| Serious AEs | 0 | 0 | 1 (12.5) | 1 [0.2] | 3 (33.3) | 4 [1.0] | ||
| Severe | 0 | 0 | 0 | 0 | ||||
| Fatal | 0 | 0 | 0 | 0 | ||||
| AEs leading to withdrawal | 0 | 0 | 0 | 0 | ||||
| Most frequent AEs, ≥5% | ||||||||
| General disorders and administration site conditions | ||||||||
| Injection site bruising | 5 (13.9) | 8 [0.5] | 0 | 0 | 0 | |||
| Injection site hematoma | 4 (11.1) | 5 [0.3] | 1 (11.1) | 1 [0.2] | 2 (25.0) | 5 [0.9] | 0 | |
| Injection site hemorrhage | 3 (8.3) | 6 [0.4] | 0 | 1 (12.5) | 5 [0.9] | 0 | ||
| Infections and infestations | ||||||||
| Nasopharyngitis | 9 (25.0) | 12 [0.7] | 0 | 3 (37.5) | 3 [0.5] | 0 | ||
| Upper respiratory tract infection | 2 (5.6) | 2 [0.1] | 1 (11.1) | 2 [0.3] | 0 | 1 (11.1) | 1 [0.3] | |
| . | HA concizumab (N = 36) . | HAwI concizumab (N = 9) . | HBwI concizumab (N = 8) . | HAwI/HBwI rFVIIa on demand (N = 9) . | ||||
|---|---|---|---|---|---|---|---|---|
| n (%) . | E [R] . | n (%) . | E [R] . | n (%) . | E [R] . | n (%) . | E [R] . | |
| Exposure time, y | 17.2 | 6.1 | 5.6 | 3.9 | ||||
| All AEs | 29 (80.6) | 130 [7.6] | 7 (77.8) | 20 [3.3] | 6 (75.0) | 23 [4.1] | 7 (77.8) | 18 [4.7] |
| Serious AEs | 0 | 0 | 1 (12.5) | 1 [0.2] | 3 (33.3) | 4 [1.0] | ||
| Severe | 0 | 0 | 0 | 0 | ||||
| Fatal | 0 | 0 | 0 | 0 | ||||
| AEs leading to withdrawal | 0 | 0 | 0 | 0 | ||||
| Most frequent AEs, ≥5% | ||||||||
| General disorders and administration site conditions | ||||||||
| Injection site bruising | 5 (13.9) | 8 [0.5] | 0 | 0 | 0 | |||
| Injection site hematoma | 4 (11.1) | 5 [0.3] | 1 (11.1) | 1 [0.2] | 2 (25.0) | 5 [0.9] | 0 | |
| Injection site hemorrhage | 3 (8.3) | 6 [0.4] | 0 | 1 (12.5) | 5 [0.9] | 0 | ||
| Infections and infestations | ||||||||
| Nasopharyngitis | 9 (25.0) | 12 [0.7] | 0 | 3 (37.5) | 3 [0.5] | 0 | ||
| Upper respiratory tract infection | 2 (5.6) | 2 [0.1] | 1 (11.1) | 2 [0.3] | 0 | 1 (11.1) | 1 [0.3] | |
Summary of TEAEs by hemophilia type in patients who received concizumab during explorer4 (HAwI/HBwI) and explorer5 (HA without inhibitors) (safety analysis set).
%, percentage of patients with adverse event; E, number of AEs; R, rate calculated as the number of AEs per patient-years of exposure.