Table 3.
Safety.
| Treatment-emergent adverse events occurring in ≥20% of patients, n (%) | Induction part (N = 40) | Monotherapy part (N = 16) | ||
|---|---|---|---|---|
| All grade | Grade 3/4 | All grade | Grade 3/4 | |
| General myelosuppression | ||||
| Anemia | 19 (47.5) | 7 (17.5) | 5 (31.3) | 1 (6.3) |
| Neutropenia | 14 (35.0) | 9 (22.5) | 3 (18.8) | 1 (6.3) |
| Thrombocytopenia | 8 (20.0) | 2 (5.0) | 0 | 0 |
| Nonhematologic events | ||||
| Nausea | 21 (52.5) | 0 | 1 (6.3) | 0 |
| Fatigue | 17 (42.5) | 3 (7.5) | 5 (31.3) | 0 |
| Asthenia | 10 (25.0) | 4 (10.0) | 2 (12.5) | 1 (6.3) |
| Dehydration | 10 (25.0) | 3 (7.5) | 1 (6.3) | 0 |
| Decreased appetite | 10 (25.0) | 2 (5.0) | 0 | 0 |
| Constipation | 9 (22.5) | 1 (2.5) | 1 (6.3) | 0 |
| Alopecia | 9 (22.5) | 0 | 0 | 0 |
| Diarrhea | 8 (20.0) | 1 (2.5) | 1 (6.3) | 0 |