Hematologic and nonhematologic toxicity
| Grade 3/4 adverse events . | MEL200 (N = 149), no. (%) . | MEL100 (N = 149), no. (%) . | P* . |
|---|---|---|---|
| Hematologic | |||
| Grade 4 neutropenia, no. (%) | 114 (77) | 100 (67) | .07 |
| Grade 4 neutropenia duration, d | |||
| Median | 6 | 6 | |
| Range | 0-15 | 0-15 | |
| Grade 4 thrombocytopenia, no. (%) | 113 (76) | 73 (49) | < .001 |
| Grade 4 thrombocytopenia duration, d | |||
| Median | 1 | 1 | |
| Range | 0-20 | 0-21 | |
| Red cell transfusion, no. (%) | 43 (29) | 48 (33) | .45 |
| Platelet transfusion, no. (%) | 82 (56) | 55 (38) | .002 |
| Hospitalization after engraftment | |||
| No. of patients (%) | 100 (68) | 90 (62) | .23 |
| Median, d | 3 | 2 | |
| Range, d | 1-25 | 1-23 | |
| Intravenous antibiotics | |||
| No. of patients (%) | 60 (41) | 42 (29) | .03 |
| Median, d | 7 | 6 | |
| Range, d | 2-28 | 2-13 | |
| Nonhematologic | |||
| Mucositis, no. (%) | 26 (17) | 5 (3) | < .001 |
| Gastrointestinal, no. (%) | 16 (11) | 2 (1) | < .001 |
| Diarrhea | 7 | 1 | |
| Vomiting | 9 | 1 | |
| Infection, no. (%) | 60 (40) | 44 (30) | .06 |
| Neutropenic fever | 26 | 26 | |
| Pneumonia | 11 | 6 | |
| Sepsis | 14 | 6 | |
| Central venous catheter | 2 | 3 | |
| Viral | 4 | 2 | |
| Other | 3 | 1 | |
| Thromboembolism, no. (%) | 3 (2) | 4 (3) | 1 |
| Deep vein thrombosis | 1 | 4 | |
| Pulmonary embolism | 2 | 0 | |
| Renal, no. (%) | 1 (1) | 0 (0) | 1 |
| Cardiac, no. (%) | 1 (1) | 0 (0) | 1 |
| Pulmonary, no. (%) | 1 (1) | 0 (0) | 1 |
| Neurologic, no. (%) | 1 (1) | 0 (0) | 1 |
| Bleeding, no. (%) | 1 (1) | 1 (1) | 1 |
| Coagulation, no. (%) | 0 (0) | 1 (1) | 1 |
| At least 1 event, no. (%) | 67 (45) | 45 (30) | .008 |
| Grade 3/4 adverse events . | MEL200 (N = 149), no. (%) . | MEL100 (N = 149), no. (%) . | P* . |
|---|---|---|---|
| Hematologic | |||
| Grade 4 neutropenia, no. (%) | 114 (77) | 100 (67) | .07 |
| Grade 4 neutropenia duration, d | |||
| Median | 6 | 6 | |
| Range | 0-15 | 0-15 | |
| Grade 4 thrombocytopenia, no. (%) | 113 (76) | 73 (49) | < .001 |
| Grade 4 thrombocytopenia duration, d | |||
| Median | 1 | 1 | |
| Range | 0-20 | 0-21 | |
| Red cell transfusion, no. (%) | 43 (29) | 48 (33) | .45 |
| Platelet transfusion, no. (%) | 82 (56) | 55 (38) | .002 |
| Hospitalization after engraftment | |||
| No. of patients (%) | 100 (68) | 90 (62) | .23 |
| Median, d | 3 | 2 | |
| Range, d | 1-25 | 1-23 | |
| Intravenous antibiotics | |||
| No. of patients (%) | 60 (41) | 42 (29) | .03 |
| Median, d | 7 | 6 | |
| Range, d | 2-28 | 2-13 | |
| Nonhematologic | |||
| Mucositis, no. (%) | 26 (17) | 5 (3) | < .001 |
| Gastrointestinal, no. (%) | 16 (11) | 2 (1) | < .001 |
| Diarrhea | 7 | 1 | |
| Vomiting | 9 | 1 | |
| Infection, no. (%) | 60 (40) | 44 (30) | .06 |
| Neutropenic fever | 26 | 26 | |
| Pneumonia | 11 | 6 | |
| Sepsis | 14 | 6 | |
| Central venous catheter | 2 | 3 | |
| Viral | 4 | 2 | |
| Other | 3 | 1 | |
| Thromboembolism, no. (%) | 3 (2) | 4 (3) | 1 |
| Deep vein thrombosis | 1 | 4 | |
| Pulmonary embolism | 2 | 0 | |
| Renal, no. (%) | 1 (1) | 0 (0) | 1 |
| Cardiac, no. (%) | 1 (1) | 0 (0) | 1 |
| Pulmonary, no. (%) | 1 (1) | 0 (0) | 1 |
| Neurologic, no. (%) | 1 (1) | 0 (0) | 1 |
| Bleeding, no. (%) | 1 (1) | 1 (1) | 1 |
| Coagulation, no. (%) | 0 (0) | 1 (1) | 1 |
| At least 1 event, no. (%) | 67 (45) | 45 (30) | .008 |
Proportions were compared with the use of the χ2 test or Fisher exact test.