Table 3

More than or equal to grade 3 adverse events at least possibly related to treatment

Adverse eventAll patients (N = 25), n (%) [95% CI]
Patients treated at MTD (n = 19*), n (%) [95% CI]
Grade 3Grade 4Grade 5Grade 3Grade 4Grade 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 eventAll patients (N = 25), n (%) [95% CI]
Patients treated at MTD (n = 19*), n (%) [95% CI]
Grade 3Grade 4Grade 5Grade 3Grade 4Grade 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.

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