Treatment-emergent AEs of all grades reported in ≥ 20% (safety population)
| Treatment-emergent AE, n (%) . | Cohort 1, 20 mg/m2 (n = 59) . | Cohort 2, 20/27 mg/m2 (n = 70) . | Total (N = 129) . |
|---|---|---|---|
| Hematologic | |||
| Anemia | 27 (45.8) | 27 (38.6) | 54 (41.9) |
| Neutropenia | 18 (30.5) | 21 (30.0) | 39 (30.2) |
| Thrombocytopenia | 20 (33.9) | 19 (27.1) | 39 (30.2) |
| Lymphopenia | 20 (33.9) | 13 (18.6) | 33 (25.6) |
| Leukopenia | 12 (20.3) | 4 (5.7) | 16 (12.4) |
| Nonhematologic | |||
| Fatigue | 42 (71.2) | 38 (54.3) | 80 (62.0) |
| Nausea | 32 (54.2) | 31 (44.3) | 63 (48.8) |
| Dyspnea | 29 (49.2) | 21 (30.0) | 50 (38.8) |
| Cough | 23 (39.0) | 21 (30.0) | 44 (34.1) |
| Pyrexia | 21 (35.6) | 23 (32.9) | 44 (34.1) |
| Headache | 19 (32.2) | 23 (32.9) | 42 (32.6) |
| Diarrhea | 21 (35.6) | 19 (27.1) | 40 (31.0) |
| Upper respiratory infection | 20 (33.9) | 20 (28.6) | 40 (31.0) |
| Peripheral edema | 17 (28.8) | 18 (25.7) | 35 (27.1) |
| Chills | 15 (25.4) | 14 (20.0) | 29 (22.5) |
| Insomnia | 11 (18.6) | 18 (25.7) | 29 (22.5) |
| Vomiting | 15 (25.4) | 14 (20.0) | 29 (22.5) |
| Constipation | 15 (25.4) | 10 (14.3) | 25 (19.4) |
| Increased serum creatinine | 14 (23.7) | 10 (14.3) | 24 (18.6) |
| Muscle spasms | 6 (10.2) | 18 (25.7) | 24 (18.6) |
| Arthralgia | 15 (25.4) | 7 (10.0) | 22 (17.1) |
| Back pain | 8 (13.6) | 14 (20.0) | 22 (17.1) |
| Dizziness | 12 (20.3) | 10 (14.3) | 22 (17.1) |
| Treatment-emergent AE, n (%) . | Cohort 1, 20 mg/m2 (n = 59) . | Cohort 2, 20/27 mg/m2 (n = 70) . | Total (N = 129) . |
|---|---|---|---|
| Hematologic | |||
| Anemia | 27 (45.8) | 27 (38.6) | 54 (41.9) |
| Neutropenia | 18 (30.5) | 21 (30.0) | 39 (30.2) |
| Thrombocytopenia | 20 (33.9) | 19 (27.1) | 39 (30.2) |
| Lymphopenia | 20 (33.9) | 13 (18.6) | 33 (25.6) |
| Leukopenia | 12 (20.3) | 4 (5.7) | 16 (12.4) |
| Nonhematologic | |||
| Fatigue | 42 (71.2) | 38 (54.3) | 80 (62.0) |
| Nausea | 32 (54.2) | 31 (44.3) | 63 (48.8) |
| Dyspnea | 29 (49.2) | 21 (30.0) | 50 (38.8) |
| Cough | 23 (39.0) | 21 (30.0) | 44 (34.1) |
| Pyrexia | 21 (35.6) | 23 (32.9) | 44 (34.1) |
| Headache | 19 (32.2) | 23 (32.9) | 42 (32.6) |
| Diarrhea | 21 (35.6) | 19 (27.1) | 40 (31.0) |
| Upper respiratory infection | 20 (33.9) | 20 (28.6) | 40 (31.0) |
| Peripheral edema | 17 (28.8) | 18 (25.7) | 35 (27.1) |
| Chills | 15 (25.4) | 14 (20.0) | 29 (22.5) |
| Insomnia | 11 (18.6) | 18 (25.7) | 29 (22.5) |
| Vomiting | 15 (25.4) | 14 (20.0) | 29 (22.5) |
| Constipation | 15 (25.4) | 10 (14.3) | 25 (19.4) |
| Increased serum creatinine | 14 (23.7) | 10 (14.3) | 24 (18.6) |
| Muscle spasms | 6 (10.2) | 18 (25.7) | 24 (18.6) |
| Arthralgia | 15 (25.4) | 7 (10.0) | 22 (17.1) |
| Back pain | 8 (13.6) | 14 (20.0) | 22 (17.1) |
| Dizziness | 12 (20.3) | 10 (14.3) | 22 (17.1) |