Table 2.
AEs of any grade occurring in at least 20% of all patients
| AE, n (%) | Phase 1 | Phase 2 |
Phase 1-2 |
|||
|---|---|---|---|---|---|---|
| 45 mg/m2 (n = 3) | 56 mg/m2 (n = 3) | 70 mg/m2 (n = 15) | 88 mg/m2 (n = 6) | 70 mg/m2 (n = 89) | 70 mg/m2 (n = 104) | |
| Fatigue | 3 (100) | 2 (67) | 9 (60) | 3 (50) | 46 (52) | 55 (53) |
| Nausea | 0 | 1 (33) | 7 (47) | 3 (50) | 31 (35) | 38 (37) |
| Insomnia | 2 (67) | 2 (67) | 5 (33) | 4 (67) | 28 (31) | 33 (32) |
| Headache | 0 | 2 (67) | 7 (47) | 4 (67) | 25 (28) | 32 (31) |
| Diarrhea | 2 (67) | 0 | 9 (60) | 2 (33) | 23 (26) | 32 (31) |
| Upper respiratory tract infection | 1 (33) | 2 (67) | 11 (73) | 2 (33) | 20 (22) | 31 (30) |
| Anemia | 2 (67) | 2 (67) | 5 (33) | 2 (33) | 24 (27) | 29 (28) |
| Dyspnea | 1 (33) | 1 (33) | 4 (27) | 2 (33) | 24 (27) | 28 (27) |
| Cough | 0 | 0 | 5 (33) | 2 (33) | 24 (27) | 29 (28) |
| Pyrexia | 0 | 0 | 7 (47) | 3 (50) | 19 (21) | 26 (25) |
| Thrombocytopenia | 0 | 0 | 3 (20) | 1 (17) | 20 (22) | 23 (22) |
| Peripheral edema | 0 | 1 (33) | 4 (27) | 0 | 18 (20) | 22 (21) |