Table 4 Adverse events during the entire observation period
Events | n = 53 | |
|---|---|---|
Any gradea | Grade 3 or higher | |
n (%) | n (%) | |
Bleeding events (overall) | 15 (28.3) | 3 (5.7) |
Thalamic bleeding | 1 (1.9) | 1 (1.9) |
Epistaxis | 7 (13.2) | 0 |
Gingival bleeding | 1 (1.9) | 0 |
Tracheal bleeding | 1 (1.9) | 0 |
Upper gastrointestinal bleeding | 1 (1.9) | 1 (1.9) |
Lower gastrointestinal bleeding | 2 (3.8) | 0 |
Gastrointestinal bleeding (site unknown) | 1 (1.9) | 1 (1.9) |
Genital bleeding | 1 (1.9) | 0 |
Anal bleeding | 2 (3.8) | 0 |
Hematuria | 2 (3.8) | 0 |
Laboratory test abnormalities (overall) | 18 (34.0) | 8 (15.1) |
Anemia | 7 (13.2) | 2 (3.8) |
Leukopenia | 6 (11.3) | 1 (1.9) |
Neutropenia | 10 (18.9) | 7 (13.2) |
Thrombocytopenia | 1 (1.9) | 0 |
Prolonged INR | 4 (7.5) | 0 |
Elevated AST | 1 (1.9) | 0 |
Elevated ALT | 1 (1.9) | 0 |
Hypoalbuminemia | 1 (1.9) | 0 |
Hypomagnesemia | 1 (1.9) | 0 |
Elevated serum creatinine | 1 (1.9) | 0 |
Proteinuria | 2 (3.8) | 0 |
Non-hematologic AE (overall) | 23 (43.4) | 3 (5.7) |
Anorexia | 5 (9.4) | 1 (1.9) |
Alopecia | 1 (1.9) | 0 |
Constipation | 2 (3.8) | 0 |
Cough | 1 (1.9) | 0 |
Diarrhea | 5 (9.4) | 1 (1.9) |
Dysgeusia | 6 (11.3) | 0 |
Edema limbs | 2 (3.8) | 0 |
Fatigue | 3 (5.7) | 0 |
Hand-foot skin reaction | 2 (3.8) | 0 |
Headache | 1 (1.9) | 0 |
Hiccups | 1 (1.9) | 0 |
Hoarseness | 2 (3.8) | 0 |
Hyperpigmentation | 1 (1.9) | 0 |
Hypertension | 2 (3.8) | 2 (3.8) |
Malaise | 4 (7.5) | 0 |
Nausea | 3 (5.7) | 0 |
Peripheral neuropathy | 4 (7.5) | 0 |
Pruritus | 1 (1.9) | 0 |
Stomatitis | 2 (3.8) | 0 |
Vomiting | 1 (1.9) | 0 |