Summary of AEs
| AE . | Overall (N = 203) . | Grade ≥3 . |
|---|---|---|
| Patients reporting treatment-emergent AEs, n (%) | 193 (95.1) | 66 (32.5) |
| Most common AEs (occurring in >20% of patients), n (%) | ||
| Epistaxis | 80 (39.4) | 9 (4.4) |
| Headache | 78 (38.4) | 6 (3.0) |
| Nasopharyngitis | 75 (36.9) | 1 (0.5) |
| Pyrexia | 65 (32.0) | 0 |
| Cough | 52 (25.6) | 0 |
| Petechiae | 48 (23.6) | 1 (0.5) |
| Vomiting | 47 (23.2) | 1 (0.5) |
| Hematoma | 42 (20.7) | 1 (0.5) |
| Serious adverse events,∗n (%) | 60 (29.6) | 43 (21.2) |
| Epistaxis | 12 (5.9) | 8 (3.9) |
| Platelet count decreased | 10 (4.9) | 9 (4.4) |
| Neutralizing antibody positive | 4 (2.0) | 2 (1.0) |
| Thrombocytopenia | 4 (2.0) | 4 (2.0) |
| Immune thrombocytopenic purpura | 3 (1.5) | 3 (1.5) |
| Abdominal pain | 2 (1.0) | 1 (0.5) |
| Anemia | 2 (1.0) | 2 (1.0) |
| Headache | 2 (1.0) | 2 (1.0) |
| Influenza | 2 (1.0) | 1 (0.5) |
| Petechiae | 2 (1.0) | 1 (0.5) |
| Presyncope | 2 (1.0) | 1 (0.5) |
| Treatment-emergent AEs leading to discontinuation, n (%) | 15 (7.4) | 6 (3.0) |
| Neutralizing antibodies† | 6 (3.0) | 1 (0.5) |
| Systemic lupus erythematosus | 3 (1.5) | 2 (1.0) |
| Headache | 2 (1.0) | 2 (1.0) |
| Abdominal pain | 1 (0.5) | 1 (0.5) |
| B-cell lymphoma | 1 (0.5) | 1 (0.5) |
| Dizziness | 1 (0.5) | 0 |
| Interstitial lung disease | 1 (0.5) | 0 |
| Mixed connective tissue disease | 1 (0.5) | 0 |
| Vomiting | 1 (0.5) | 1 (0.5) |
| Treatment-related AEs, n (%) | 56 (27.6) | 8 (3.9) |
| Leading to discontinuation | 8 (3.9) | 3 (1.5) |
| Treatment-related serious AEs, n (%)‡ | 8 (3.9) | 5 (2.5) |
| Neutralizing antibody positive | 4 (2.0) | 2 (1.0) |
| Abdominal pain | 2 (1.0) | 1 (0.5) |
| Headache | 2 (1.0) | 2 (1.0) |
| Presyncope | 1 (0.5) | 0 |
| AE . | Overall (N = 203) . | Grade ≥3 . |
|---|---|---|
| Patients reporting treatment-emergent AEs, n (%) | 193 (95.1) | 66 (32.5) |
| Most common AEs (occurring in >20% of patients), n (%) | ||
| Epistaxis | 80 (39.4) | 9 (4.4) |
| Headache | 78 (38.4) | 6 (3.0) |
| Nasopharyngitis | 75 (36.9) | 1 (0.5) |
| Pyrexia | 65 (32.0) | 0 |
| Cough | 52 (25.6) | 0 |
| Petechiae | 48 (23.6) | 1 (0.5) |
| Vomiting | 47 (23.2) | 1 (0.5) |
| Hematoma | 42 (20.7) | 1 (0.5) |
| Serious adverse events,∗n (%) | 60 (29.6) | 43 (21.2) |
| Epistaxis | 12 (5.9) | 8 (3.9) |
| Platelet count decreased | 10 (4.9) | 9 (4.4) |
| Neutralizing antibody positive | 4 (2.0) | 2 (1.0) |
| Thrombocytopenia | 4 (2.0) | 4 (2.0) |
| Immune thrombocytopenic purpura | 3 (1.5) | 3 (1.5) |
| Abdominal pain | 2 (1.0) | 1 (0.5) |
| Anemia | 2 (1.0) | 2 (1.0) |
| Headache | 2 (1.0) | 2 (1.0) |
| Influenza | 2 (1.0) | 1 (0.5) |
| Petechiae | 2 (1.0) | 1 (0.5) |
| Presyncope | 2 (1.0) | 1 (0.5) |
| Treatment-emergent AEs leading to discontinuation, n (%) | 15 (7.4) | 6 (3.0) |
| Neutralizing antibodies† | 6 (3.0) | 1 (0.5) |
| Systemic lupus erythematosus | 3 (1.5) | 2 (1.0) |
| Headache | 2 (1.0) | 2 (1.0) |
| Abdominal pain | 1 (0.5) | 1 (0.5) |
| B-cell lymphoma | 1 (0.5) | 1 (0.5) |
| Dizziness | 1 (0.5) | 0 |
| Interstitial lung disease | 1 (0.5) | 0 |
| Mixed connective tissue disease | 1 (0.5) | 0 |
| Vomiting | 1 (0.5) | 1 (0.5) |
| Treatment-related AEs, n (%) | 56 (27.6) | 8 (3.9) |
| Leading to discontinuation | 8 (3.9) | 3 (1.5) |
| Treatment-related serious AEs, n (%)‡ | 8 (3.9) | 5 (2.5) |
| Neutralizing antibody positive | 4 (2.0) | 2 (1.0) |
| Abdominal pain | 2 (1.0) | 1 (0.5) |
| Headache | 2 (1.0) | 2 (1.0) |
| Presyncope | 1 (0.5) | 0 |