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.