Table 2.
Adverse events of at least possible attribution to study treatment present in at least 8% of patients (including laboratory abnormalities considered clinically significant by the treating investigator)
| Event, n (%) | All grades | ≥ Grade 3 |
|---|---|---|
| Fatigue | 12 (48) | 0 |
| Infusion related reaction | 11 (44) | 0 |
| Nausea | 9 (36) | 0 |
| Diarrhea | 9 (36) | 1 (4) |
| Neutropenia | 9 (36) | 7 (28) |
| Thrombocytopenia | 7 (28) | 2 (8) |
| Fever | 6 (24) | 0 |
| Anemia | 5 (20) | 2 (8) |
| Constipation | 4 (16) | 0 |
| Leukopenia | 3 (12) | 0 |
| Dysgeusia | 3 (12) | 0 |
| Chills | 3 (12) | 0 |
| Febrile neutropenia | 2 (8) | 2 (8) |
| Vomiting | 2 (8) | 0 |
| Upper respiratory/bronchial infection | 2 (8) | 2 (8) |
| AST increase | 2 (8) | 1 (4) |
| Creatinine increase | 2 (8) | 0 |
| Lymphopenia | 2 (8) | 1 (4) |
| Anorexia | 2 (8) | 0 |
| Dizziness | 2 (8) | 0 |
| Rash | 2 (8) | 0 |