Adverse events of the phase 1b/2 study
| AE | Phase 1b (n = 15) | Phase 2 (n = 113) | ||||||
|---|---|---|---|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |||||
| n | % | n | % | n | % | n | % | |
| Leucopenia | 14 | 93.3 | 9 | 60.0 | 93 | 82.3 | 78 | 69.0 |
| Anemia | 11 | 73.3 | 4 | 26.7 | 93 | 82.3 | 42 | 37.2 |
| Neutropenia | 11 | 73.3 | 10 | 66.7 | 86 | 76.1 | 78 | 69.0 |
| Thrombocytopenia | 8 | 53.3 | 5 | 33.3 | 58 | 51.3 | 35 | 31.0 |
| Nausea/vomiting | 6 | 40.0 | 72 | 63.7 | 5 | 4.4 | ||
| Fever | 4 | 26.7 | 2 | 13.3 | 42 | 37.2 | 12 | 10.6 |
| Hypokalemia | 4 | 26.7 | 34 | 30.1 | 17 | 15.0 | ||
| Hypocalcaemia | 8 | 53.3 | 1 | 6.7 | 25 | 22.1 | 3 | 2.7 |
| Hypoalbuminemia | 4 | 26.7 | 32 | 28.3 | 2 | 1.8 | ||
| Upper respiratory tract infection | 4 | 26.7 | 1 | 6.7 | 20 | 17.7 | 3 | 2.7 |
| Pulmonary infection | 1 | 6.7 | 1 | 6.7 | 15 | 13.3 | 7 | 6.2 |
| Fatigue | 3 | 20.0 | 1 | 6.7 | 12 | 10.6 | ||
| Hyponatremia | 2 | 13.3 | 2 | 13.3 | 12 | 10.6 | 12 | 10.6 |
| Hyperglycemia | 2 | 13.3 | 12 | 10.6 | 7 | 6.2 | ||
| ALT/AST elevation | 2 | 13.3 | 8 | 7.1 | 3 | 2.7 | ||
| BUN elevation | 1 | 6.7 | 8 | 7.1 | 3 | 2.7 | ||
| Skin rash | 1 | 6.7 | 7 | 6.2 | ||||
| Lower limb edema | 7 | 6.2 | 2 | 1.8 | ||||