Table 7.
Treatment-emergent AEs ≥ grade 3 in ≥ 5% (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 | |||
| Lymphopenia | 8 (13.6) | 13 (18.6) | 21 (16.3) |
| Anemia | 7 (11.9) | 12 (17.1) | 19 (14.7) |
| Neutropenia | 7 (11.9) | 10 (14.3) | 17 (13.2) |
| Thrombocytopenia | 9 (15.3) | 8 (11.4) | 17 (13.2) |
| Leukopenia | 4 (6.8) | 1 (1.4) | 5 (3.9) |
| Nonhematologic | |||
| Pneumonia | 8 (13.6) | 8 (11.4) | 16 (12.4) |
| Fatigue | 7 (11.9) | 1 (1.4) | 8 (6.2) |
| Dyspnea | 3 (5.1) | 4 (5.7) | 7 (5.4) |
| Acute renal failure | 2 (3.4) | 4 (5.7) | 6 (4.7) |
| Congestive heart failure | 2 (3.4) | 4 (5.7) | 6 (4.7) |
| Serum phosphorus decrease | 1 (1.7) | 5 (7.1) | 6 (4.7) |
| Hyperglycemia | 4 (6.8) | 2 (2.9) | 6 (4.7) |
| Hypophosphatemia | 1 (1.7) | 5 (7.1) | 6 (4.7) |
| Hypokalemia | 1 (1.7) | 4 (5.7) | 5 (3.9) |
| Hyponatremia | 0 (0.0) | 5 (7.1) | 5 (3.9) |
| Serum sodium decreased | 4 (6.8) | 0 (0.0) | 4 (3.1) |
| AST increase | 3 (5.1) | 0 (0.0) | 3 (2.3) |
AST indicates aspartate aminotransferase.