Table 3.
Treatment-emergent AEs with maximum CTC grade by dose level (incidence ≥ 20%)
| Total (N = 16) | 60 mg/m2
N = 3 |
80 mg/m2
N = 6 |
100 mg/m2
N = 5 |
120 mg/m2
N = 2 |
|
|---|---|---|---|---|---|
| AE | All grade | Grade 3–4 | |||
| Anemia | 7 (43.8%) | 0 | 0 | 2 (40%) | 0 |
| Leukopenia | 6 (37.5%) | 0 | 0 | 2 (40%) | 1 (50%) |
| Neutropenia | 6 (37.5%) | 1 (33.3%) | 1 (16.7%) | 2 (40%) | 1 (50%) |
| Abdominal pain | 7 (43.8%) | 0 | 0 | 1 (20%) | 1 (50%) |
| Diarrhea | 12 (75.0%) | 0 | 1 (16.7%) | 2 (40%) | 2 (100%) |
| Nausea | 13 (81.3%) | 0 | 1 (16.7%) | 0 | 0 |
| Vomiting | 12 (75.0%) | 0 | 1 (16.7%) | 0 | 0 |
| Fatigue | 8 (50.0%) | 0 | 0 | 1 (20%) | 0 |
| Infection | 6 (37.5%) | 0 | 0 | 2 (40%) | 1 (50%) |
| Anorexia | 4 (25.0%) | 0 | 0 | 1 (20%) | 0 |
| Hypoalbuminemia | 4 (25.0%) | 0 | 1 (16.7%) | 0 | 0 |
| Hypokalemia | 8 (50.0%) | 1 (33.3%) | 2 (33.3%) | 2 (40%) | 1 (50%) |
| Hyponatremia | 4 (25.0%) | 0 | 0 | 1 (20%) | 1 (50%) |
| Cough | 5 (31.3%) | 1 (33.3%) | 0 | 0 | 0 |
Abbreviation: AE adverse event