More than or equal to grade 3 adverse events at least possibly related to treatment
| Adverse event . | All patients (N = 25), n (%) [95% CI] . | Patients treated at MTD (n = 19*), n (%) [95% CI] . | ||||
|---|---|---|---|---|---|---|
| Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Any hematological | 9 (36%) [18%-57%] | 9 (36%) [18%-57%] | 7 (37%) [16%-62%] | 6 (32%) [15%-57%] | ||
| Thrombocytopenia | 40% [21c61%] | 24% [9%-45%] | 42% [20%-67%] | 16% [3%-40%] | ||
| Anaemia | 24% [9%-45%] | 12% [3%-31%] | 21% [6%-46%] | 11% [1%-33%] | ||
| Neutropenia | 24% [9%-45%] | 12% [3%-31%] | 26% [9%-51%] | 11% [1%-33%] | ||
| Febrile neutropenia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Any nonhematological | 8 (32%) [15%-54%] | 6 (24%) [9%-45%] | 1 (4%) [0%-20%] | 5 (26%) [9%-51%] | 5 (26%) [9%-51%] | |
| Neuropathy: sensory | 8% [1%-26%] | 5% [0%-26%] | ||||
| Fatigue (asthenia lethargy malaise) | 12% [3%-31%] | 8% [1%-26%] | 5% [0%-26%] | 5% [0%-26%] | ||
| Gastrointestinal | 4% [0%-20%] | 0% [0%-18%] | ||||
| Constipation | 4% [0%-20%] | 0% [0%-18%] | ||||
| Diarrhea | 4% [0%-20%] | 5% [0%-26%] | ||||
| Vomiting | 4% [0%-20%] | 5% [0%-26%] | ||||
| Dizziness | 4% [0%-20%] | 5% [0%-26%] | ||||
| Infection with < 2 neutrophils | 8% [1%-26%] | 4% [0%-20%] | 5% [0%-26%] | 5% [0%-26%] | ||
| Elevated creatinine | 4% [0%-20%] | 0% [0%-18%] | ||||
| Hyperkalemia | 8% [1%-26%] | 11% [1%-33%] | ||||
| Hypokalemia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Hyponatremia | 20% [7%-41%] | 16% [3%-40%] | ||||
| Hyperglycemia | 8% [1%-26%] | 4% [0%-20%] | 11% [1%-33%] | 5% [0%-26%] | ||
| Elevated ALT | 8% [1%-26%] | 5% [0%-26%] | ||||
| Hypocalcemia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Hypercalcemia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Pain | 4% [0%-20%] | 5% [0%-26%] | ||||
| Hemorrhage CNS | 4% [0%-20%] | 0% [0%-18%] | ||||
| Adverse event . | All patients (N = 25), n (%) [95% CI] . | Patients treated at MTD (n = 19*), n (%) [95% CI] . | ||||
|---|---|---|---|---|---|---|
| Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Any hematological | 9 (36%) [18%-57%] | 9 (36%) [18%-57%] | 7 (37%) [16%-62%] | 6 (32%) [15%-57%] | ||
| Thrombocytopenia | 40% [21c61%] | 24% [9%-45%] | 42% [20%-67%] | 16% [3%-40%] | ||
| Anaemia | 24% [9%-45%] | 12% [3%-31%] | 21% [6%-46%] | 11% [1%-33%] | ||
| Neutropenia | 24% [9%-45%] | 12% [3%-31%] | 26% [9%-51%] | 11% [1%-33%] | ||
| Febrile neutropenia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Any nonhematological | 8 (32%) [15%-54%] | 6 (24%) [9%-45%] | 1 (4%) [0%-20%] | 5 (26%) [9%-51%] | 5 (26%) [9%-51%] | |
| Neuropathy: sensory | 8% [1%-26%] | 5% [0%-26%] | ||||
| Fatigue (asthenia lethargy malaise) | 12% [3%-31%] | 8% [1%-26%] | 5% [0%-26%] | 5% [0%-26%] | ||
| Gastrointestinal | 4% [0%-20%] | 0% [0%-18%] | ||||
| Constipation | 4% [0%-20%] | 0% [0%-18%] | ||||
| Diarrhea | 4% [0%-20%] | 5% [0%-26%] | ||||
| Vomiting | 4% [0%-20%] | 5% [0%-26%] | ||||
| Dizziness | 4% [0%-20%] | 5% [0%-26%] | ||||
| Infection with < 2 neutrophils | 8% [1%-26%] | 4% [0%-20%] | 5% [0%-26%] | 5% [0%-26%] | ||
| Elevated creatinine | 4% [0%-20%] | 0% [0%-18%] | ||||
| Hyperkalemia | 8% [1%-26%] | 11% [1%-33%] | ||||
| Hypokalemia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Hyponatremia | 20% [7%-41%] | 16% [3%-40%] | ||||
| Hyperglycemia | 8% [1%-26%] | 4% [0%-20%] | 11% [1%-33%] | 5% [0%-26%] | ||
| Elevated ALT | 8% [1%-26%] | 5% [0%-26%] | ||||
| Hypocalcemia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Hypercalcemia | 4% [0%-20%] | 0% [0%-18%] | ||||
| Pain | 4% [0%-20%] | 5% [0%-26%] | ||||
| Hemorrhage CNS | 4% [0%-20%] | 0% [0%-18%] | ||||
n = 19 including 1 in accelerated phase, 3 in standard escalation, and 15 in expansion phase.