Table 2.
Adverse Event | Phase IB | Phase II | ||
---|---|---|---|---|
N = 30 | N = 47 | |||
Number of patients (%) | Number of patients (%) | |||
All Grades | Grade ≥ 3 | All Grades | Grade ≥ 3 | |
Fatigue | 19 (63) | 6 (20) | 17 (36) | 11 (23) |
| ||||
Anemia | 10 (33) | 4 (13) | 1 (2) | 1 (2) |
| ||||
Nausea/vomiting | 9 (30) | 1 (3) | 3 (6) | 2 (4) |
| ||||
Thrombocytopenia | 8 (26) | 1(3) | 5 (11) | 0 |
| ||||
Neutropenia | 7 (23) | 7 (23) | 6 (13) | 3 (6) |
| ||||
Diarrhea | 5 (17) | 2 (7) | 7 (15) | 3 (6) |
| ||||
Pleural Effusion | 0 | 0 | 7 (9) | 5 (11) |
| ||||
Peripheral neuropathy | 0 | 0 | 5 (11) | 0 |
| ||||
Acute renal failure | 0 | 0 | 4 (9) | 0 |
| ||||
Anorexia | 0 | 0 | 3 (6) | 2 (4) |
| ||||
Mucositis | 0 | 0 | 3(6) | 1 (2) |
| ||||
Dyspnea | 0 | 0 | 1 (2) | 1 (2) |
| ||||
Bleeding | 0 | 0 | 1 (2) | 1 (2) |
| ||||
Hypokalemia | 0 | 0 | 1 (2) | 1 (2) |
| ||||
Hemorrhagic shock (death) | 0 | 0 | 1 (2) | 1 (2) |
| ||||
Deep vein thrombosis | 0 | 0 | 1 (2) | 0 |
| ||||
Rash | 0 | 0 | 1 (2) | 0 |
| ||||
Cardiomyopathy | 0 | 0 | 1 (2) | 0 |