Table 3.
Grade 3 (or higher) AEs occurring in at least 3% 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 | 0 | 0 | 1 (7) | 1 (17) | 10 (11) | 11 (11) |
| Pneumonia | 0 | 0 | 1 (7) | 0 | 5 (6) | 6 (6) |
| Acute kidney injury | 0 | 0 | 0 | 0 | 6 (7) | 6 (6) |
| Hypertension | 0 | 0 | 0 | 0 | 7 (8) | 7 (7) |
| Thrombocytopenia | 0 | 0 | 2 (13) | 0 | 4 (4) | 6 (6) |
| Anemia | 0 | 0 | 0 | 0 | 6 (7) | 6 (6) |
| Asthenia | 0 | 0 | 0 | 0 | 5 (6) | 5 (5) |
| Back pain | 0 | 0 | 2 (13) | 0 | 3 (3) | 5 (5) |
| COPD | 0 | 0 | 2 (13) | 0 | 3 (3) | 5 (5) |
| Blood creatinine increased | 1 (33) | 0 | 0 | 0 | 3 (3) | 3 (3) |
| Congestive cardiac failure | 0 | 0 | 0 | 1 (17) | 2 (2) | 2 (2) |
| Diarrhea | 0 | 0 | 0 | 0 | 4 (4) | 4 (4) |
| Headache | 0 | 0 | 1 (7) | 1 (17) | 2 (2) | 3 (3) |
| Hypokalemia | 1 (33) | 0 | 0 | 0 | 3 (3) | 3 (3) |
| Hypoxia | 0 | 0 | 0 | 0 | 4 (4) | 4 (4) |
| Neutropenia | 0 | 0 | 1 (7) | 0 | 3 (3) | 4 (4) |
| Pain in extremity | 0 | 0 | 1 (7) | 0 | 2 (2) | 3 (3) |
| Upper respiratory tract infection | 0 | 1 (33) | 1 (7) | 1 (17) | 0 | 1 (1) |
| Sepsis | 0 | 0 | 0 | 0 | 3 (3) | 3 (3) |
| Dyspnea | 0 | 0 | 1 (7) | 0 | 4 (4) | 5 (5) |
| Hypophosphatemia | 0 | 0 | 0 | 0 | 3 (3) | 3 (3) |
| Hyperglycemia | 0 | 0 | 0 | 1 (17) | 2 (2) | 2 (2) |
| Spinal cord compression | 0 | 0 | 1 (7) | 0 | 2 (2) | 3 (3) |
COPD, chronic obstructive pulmonary disease.