Table 1.
Treatment-emergent adverse events reported in ≥10% of the safety population (n = 45).
| Treatment-emergent adverse events | Any grade No. (%) |
Grade 1/2 No. (%) |
Grade 3 No. (%) |
Grade 4 No. (%) |
|---|---|---|---|---|
| Any events | 45 (100) | 16 (36) | 21 (47) | 8 (18) |
| Hypertension | 40 (89) | 34 (76) | 6 (13) | 0 |
| Anemia | 34 (76) | 28 (62) | 6 (13) | 0 |
| Leukopenia | 34 (76) | 22 (49) | 9 (20) | 3 (7) |
| Thrombocytopenia | 31 (69) | 20 (44) | 7 (16) | 4 (9) |
| Neutropenia | 28 (62) | 11 (24) | 13 (29) | 4 (9) |
| Hand-foot syndrome | 26 (58) | 26 (58) | 0 | 0 |
| GGT elevation | 22 (49) | 20 (44) | 2 (4) | 0 |
| Increased ALT | 20 (44) | 19 (42) | 1 (2) | 0 |
| Increased AST | 15 (33) | 15 (33) | 0 | 0 |
| Fatigue | 13 (29) | 13 (29) | 0 | 0 |
| Vomiting | 12 (27) | 12 (27) | 0 | 0 |
| Headache | 11 (24) | 11 (24) | 0 | 0 |
| Skin allergy | 10 (22) | 9 (20) | 1 (2) | 0 |
| Inappetence | 9 (20) | 9 (20) | 0 | 0 |
| Oropharyngeal pain | 10 (22) | 9 (20) | 1 (2) | 0 |
| Breast pain | 9 (20) | 9 (20) | 0 | 0 |
| Gingival pain | 9 (20) | 9 (20) | 0 | 0 |
| Diarrhea | 8 (18) | 8 (18) | 0 | 0 |
| Increased ALP | 6 (13) | 6 (13) | 0 | 0 |
| Nausea | 5 (11) | 5 (11) | 0 | 0 |
| Dizzy | 5 (11) | 5 (11) | 0 | 0 |
| Cough | 5 (11) | 5 (11) | 0 | 0 |
| Abdominal pain | 5 (11) | 5 (11) | 0 | 0 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ALP, alkaline phosphatase.