Table 8.
Treatment-related AEs of all grades reported in ≥ 20% (safety population)
| Treatment-related AE, n (%) | Cohort 1, 20 mg/m2 (n = 59) | Cohort 2, 20/27 mg/m2 (n = 70) | Total (N = 129) |
|---|---|---|---|
| Hematologic | |||
| Anemia | 21 (35.6) | 19 (27.1) | 40 (31.0) |
| Thrombocytopenia | 14 (23.7) | 16 (22.9) | 30 (23.3) |
| Neutropenia | 11 (18.6) | 18 (25.7) | 29 (22.5) |
| Lymphopenia | 17 (28.8) | 11 (15.7) | 28 (21.7) |
| Nonhematologic | |||
| Fatigue | 31 (52.5) | 27 (38.6) | 58 (45.0) |
| Nausea | 27 (45.8) | 27 (38.6) | 54 (41.9) |
| Dyspnea | 21 (35.6) | 15 (21.4) | 36 (27.9) |
| Pyrexia | 12 (20.3) | 12 (17.1) | 24 (18.6) |
| Diarrhea | 14 (23.7) | 9 (12.9) | 23 (17.8) |
| Headache | 7 (11.9) | 14 (20.0) | 21 (16.3) |
| Peripheral edema | 12 (20.3) | 5 (7.1) | 17 (13.2) |
| Constipation | 12 (20.3) | 4 (5.7) | 16 (12.4) |
| Cough | 12 (20.3) | 3 (4.3) | 15 (11.6) |