Adverse events summary and outcome of treatment
| Variable . | N (%) . |
|---|---|
| Safety evaluable patients | 26 |
| Grade ≥3 hematologic toxicities (grades 3 + 4/grade 4) Neutropenia Anemia Thrombocytopenia | 17 (65)/15 (58) 16 (62)/0 13 (50)/11 (42) |
| Grade ≥3 nonhematologic toxicities occurring (grades 3/4) Febrile neutropenia Hypophosphatemia Hyponatremia Hyperglycemia | 7 (27)/3 (12) 6 (23)/0 4 (15)/0 4 (15)/1 (4) |
| Grade ≥3 infectious toxicities (grades 3-5) Pneumonia Sepsis Enterocolitis Sinusitis | 2 (8)/1 (4)/0 0/2 (8)/1 (4) 2 (8)/1 (4)/0 2 (8)/0/0 |
| Protocol-defined efficacy evaluable patients | 20 |
| Response to treatment in evaluable patients Complete response at end of combination therapy Complete response at any time on study Partial response at any time on study | 16 (80) 9 (45) 13 (65) 3 (15) |
| Response not achieved (in all 26 study patients who received study therapy) Progression of disease before starting combination therapy Toxicity before starting combination therapy Withdrawal of consent before starting combination therapy Progression of disease after starting combination therapy | 10 (38) 3 2 1 4 |
| Variable . | N (%) . |
|---|---|
| Safety evaluable patients | 26 |
| Grade ≥3 hematologic toxicities (grades 3 + 4/grade 4) Neutropenia Anemia Thrombocytopenia | 17 (65)/15 (58) 16 (62)/0 13 (50)/11 (42) |
| Grade ≥3 nonhematologic toxicities occurring (grades 3/4) Febrile neutropenia Hypophosphatemia Hyponatremia Hyperglycemia | 7 (27)/3 (12) 6 (23)/0 4 (15)/0 4 (15)/1 (4) |
| Grade ≥3 infectious toxicities (grades 3-5) Pneumonia Sepsis Enterocolitis Sinusitis | 2 (8)/1 (4)/0 0/2 (8)/1 (4) 2 (8)/1 (4)/0 2 (8)/0/0 |
| Protocol-defined efficacy evaluable patients | 20 |
| Response to treatment in evaluable patients Complete response at end of combination therapy Complete response at any time on study Partial response at any time on study | 16 (80) 9 (45) 13 (65) 3 (15) |
| Response not achieved (in all 26 study patients who received study therapy) Progression of disease before starting combination therapy Toxicity before starting combination therapy Withdrawal of consent before starting combination therapy Progression of disease after starting combination therapy | 10 (38) 3 2 1 4 |