Summary of overall AEs (occurring in ≥5 patients) or grade 3/4 AEs (occurring in ≥2 patients)
| Preferred term, n (%) . | Any AE . | Grade 3 . | Grade 4 . |
|---|---|---|---|
| All events | 116 (50.9) | 30 (13.2) | 17 (7.5) |
| Upper respiratory tract infection | 19 (8.3) | 1 (0.4) | 1 (0.4) |
| Headache | 15 (6.6) | 1 (0.4) | 1 (0.4) |
| Anemia | 10 (4.4) | 3 (1.3) | − |
| Thrombocytopenia | 10 (4.4) | 4 (1.8) | 5 (2.2) |
| Pyrexia | 8 (3.5) | 2 (0.9) | − |
| Alanine aminotransferase increase | 8 (3.5) | 3 (1.3) | − |
| Cough | 7 (3.1) | − | − |
| Epistaxis | 7 (3.1) | 7 (3.1) | − |
| Arthralgia | 6 (2.6) | − | − |
| Bone pain | 6 (2.6) | − | − |
| Rash | 6 (2.6) | − | − |
| Abdominal pain upper | 5 (2.2) | − | − |
| Diarrhea | 5 (2.2) | − | − |
| Nausea | 5 (2.2) | − | − |
| Urinary tract infection | 5 (2.2) | − | 1 (0.4) |
| Dizziness | 5 (2.2) | 1 (0.4) | − |
| Hypoesthesia | 5 (2.2) | − | − |
| Immune thrombocytopenia | 4 (1.8) | 1 (0.4) | 1 (0.4) |
| Gastritis | 4 (1.8) | 2 (0.9) | − |
| Gingival bleeding | 3 (1.3) | 2 (0.9) | 1 (0.4) |
| Blood bilirubin increase | 3 (1.3) | 2 (0.9) | − |
| Hemoglobin decrease | 3 (1.3) | 2 (0.9) | − |
| Vaginal hemorrhage | 3 (1.3) | 2 (0.9) | 1 (0.4) |
| Platelet count decrease | 2 (0.9) | − | 2 (0.9) |
| Hematuria | 2 (0.9) | 2 (0.9) | − |
| Preferred term, n (%) . | Any AE . | Grade 3 . | Grade 4 . |
|---|---|---|---|
| All events | 116 (50.9) | 30 (13.2) | 17 (7.5) |
| Upper respiratory tract infection | 19 (8.3) | 1 (0.4) | 1 (0.4) |
| Headache | 15 (6.6) | 1 (0.4) | 1 (0.4) |
| Anemia | 10 (4.4) | 3 (1.3) | − |
| Thrombocytopenia | 10 (4.4) | 4 (1.8) | 5 (2.2) |
| Pyrexia | 8 (3.5) | 2 (0.9) | − |
| Alanine aminotransferase increase | 8 (3.5) | 3 (1.3) | − |
| Cough | 7 (3.1) | − | − |
| Epistaxis | 7 (3.1) | 7 (3.1) | − |
| Arthralgia | 6 (2.6) | − | − |
| Bone pain | 6 (2.6) | − | − |
| Rash | 6 (2.6) | − | − |
| Abdominal pain upper | 5 (2.2) | − | − |
| Diarrhea | 5 (2.2) | − | − |
| Nausea | 5 (2.2) | − | − |
| Urinary tract infection | 5 (2.2) | − | 1 (0.4) |
| Dizziness | 5 (2.2) | 1 (0.4) | − |
| Hypoesthesia | 5 (2.2) | − | − |
| Immune thrombocytopenia | 4 (1.8) | 1 (0.4) | 1 (0.4) |
| Gastritis | 4 (1.8) | 2 (0.9) | − |
| Gingival bleeding | 3 (1.3) | 2 (0.9) | 1 (0.4) |
| Blood bilirubin increase | 3 (1.3) | 2 (0.9) | − |
| Hemoglobin decrease | 3 (1.3) | 2 (0.9) | − |
| Vaginal hemorrhage | 3 (1.3) | 2 (0.9) | 1 (0.4) |
| Platelet count decrease | 2 (0.9) | − | 2 (0.9) |
| Hematuria | 2 (0.9) | 2 (0.9) | − |