Safety summary
| . | Participants (N = 55) . |
|---|---|
| Total number of AEs, n | 631 |
| Participants with ≥1 AE, n (%) | 55 (100) |
| AE with fatal outcome | 0 (0) |
| AE leading to withdrawal from treatment | 0 (0) |
| AE leading to dose modification/interruption | 0 (0) |
| Participants with ≥1 grade ≥3 AE, n (%) | 17 (30.9) |
| Participants with ≥1 treatment-related AE,∗ n (%) | 9 (16.4) |
| Injection-site reaction, number of events | 30 |
| Total number of SAEs,† n | 30 |
| Participants with ≥1 SAE, n (%) | 16 (29.1) |
| AEs of special interest, n (%) | 1 (1.8) |
| Systemic hypersensitivity/anaphylactic/anaphylactoid reaction | 1 (1.8)‡ |
| Thromboembolic event | 0 (0) |
| Thrombotic microangiopathy | 0 (0) |
| . | Participants (N = 55) . |
|---|---|
| Total number of AEs, n | 631 |
| Participants with ≥1 AE, n (%) | 55 (100) |
| AE with fatal outcome | 0 (0) |
| AE leading to withdrawal from treatment | 0 (0) |
| AE leading to dose modification/interruption | 0 (0) |
| Participants with ≥1 grade ≥3 AE, n (%) | 17 (30.9) |
| Participants with ≥1 treatment-related AE,∗ n (%) | 9 (16.4) |
| Injection-site reaction, number of events | 30 |
| Total number of SAEs,† n | 30 |
| Participants with ≥1 SAE, n (%) | 16 (29.1) |
| AEs of special interest, n (%) | 1 (1.8) |
| Systemic hypersensitivity/anaphylactic/anaphylactoid reaction | 1 (1.8)‡ |
| Thromboembolic event | 0 (0) |
| Thrombotic microangiopathy | 0 (0) |
All treatment-related AEs were grade 1 local injection-site reactions.
None of the SAEs were considered emicizumab related, and all were considered serious because of hospitalization. SAEs included fall (n = 4); head injury (n = 4); bronchiolitis, bronchitis, pneumonia, tonsillitis, mouth hemorrhage, tongue hemorrhage (n = 2 for each); and ear infection, laryngitis, upper respiratory tract infection, urinary tract infection, viral infection, eyelid contusion, postprocedural fever (liver biopsy because of fluctuating liver enzymes assessed locally; serology test results for Epstein-Barr virus, cytomegalovirus, human herpesvirus 6 and hepatitis A, B, and C were negative, and no liver pathology was found), postprocedural hemorrhage (tonsillectomy), skin laceration, and tongue injury (n = 1 for each).
One anaphylactic reaction due to an egg allergy was reported in 1 participant, considered not related to emicizumab.