Grade ≥ 3 treatment-related adverse events observed in ≥ 10% of patients (N = 25)
| AE . | Grade ≥ 3 . | Grade 3 . | Grade 4 . | Grade 5 . | All grades . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of patients . | % of patients . | No. of patients . | % of patients . | No. of patients . | % of patients . | No. of patients . | % of patients . | No. of patients . | % of patients . | |
| Anemia | 16 | 64 | 15 | 60 | 1 | 4 | 0 | 0 | 16 | 64 |
| Thrombocytopenia | 16 | 64 | 0 | 0 | 16 | 64 | 0 | 0 | 16 | 64 |
| Febrile neutropenia | 15 | 60 | 7 | 28 | 8 | 32 | 0 | 0 | 15 | 60 |
| Neutropenia | 13 | 52 | 2 | 8 | 11 | 44 | 0 | 0 | 13 | 52 |
| Increased AST | 10 | 40 | 9 | 36 | 1 | 4 | 0 | 0 | 12 | 48 |
| Hypokalemia | 9 | 36 | 6 | 24 | 3 | 12 | 0 | 0 | 9 | 36 |
| Increased ALT | 7 | 28 | 7 | 28 | 0 | 0 | 0 | 0 | 9 | 36 |
| Hypotension | 6 | 24 | 5 | 20 | 1 | 4 | 0 | 0 | 10 | 40 |
| Decreased appetite | 5 | 20 | 5 | 20 | 0 | 0 | 0 | 0 | 11 | 44 |
| Increased lipase | 5 | 20 | 4 | 16 | 1 | 4 | 0 | 0 | 5 | 20 |
| Leukopenia | 4 | 16 | 1 | 4 | 3 | 12 | 0 | 0 | 4 | 16 |
| Pyrexia | 4 | 16 | 3 | 12 | 1 | 4 | 0 | 0 | 13 | 52 |
| Acute renal failure | 4 | 16 | 0 | 0 | 2 | 8 | 2 | 8 | 4 | 16 |
| Septic shock | 4 | 16 | 0 | 0 | 3 | 12 | 1 | 4 | 4 | 16 |
| Typhlitis | 3 | 12 | 1 | 4 | 2 | 8 | 0 | 0 | 3 | 12 |
| Coagulopathy | 3 | 12 | 2 | 8 | 1 | 4 | 0 | 0 | 3 | 12 |
| Enterococcal bacteremia | 3 | 12 | 3 | 12 | 0 | 0 | 0 | 0 | 3 | 12 |
| Gingival bleeding | 3 | 12 | 3 | 12 | 0 | 0 | 0 | 0 | 4 | 16 |
| Hyperbilirubinemia | 3 | 12 | 1 | 4 | 2 | 8 | 0 | 0 | 7 | 28 |
| Hypophosphatemia | 3 | 12 | 2 | 8 | 1 | 4 | 0 | 0 | 4 | 16 |
| Nausea | 3 | 12 | 3 | 12 | 0 | 0 | 0 | 0 | 18 | 72 |
| Pulmonary edema | 3 | 12 | 0 | 0 | 2 | 8 | 1 | 4 | 3 | 12 |
| VOD | 3 | 12 | 1 | 4 | 0 | 0 | 2 | 8 | 3 | 12 |
| AE . | Grade ≥ 3 . | Grade 3 . | Grade 4 . | Grade 5 . | All grades . | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. of patients . | % of patients . | No. of patients . | % of patients . | No. of patients . | % of patients . | No. of patients . | % of patients . | No. of patients . | % of patients . | |
| Anemia | 16 | 64 | 15 | 60 | 1 | 4 | 0 | 0 | 16 | 64 |
| Thrombocytopenia | 16 | 64 | 0 | 0 | 16 | 64 | 0 | 0 | 16 | 64 |
| Febrile neutropenia | 15 | 60 | 7 | 28 | 8 | 32 | 0 | 0 | 15 | 60 |
| Neutropenia | 13 | 52 | 2 | 8 | 11 | 44 | 0 | 0 | 13 | 52 |
| Increased AST | 10 | 40 | 9 | 36 | 1 | 4 | 0 | 0 | 12 | 48 |
| Hypokalemia | 9 | 36 | 6 | 24 | 3 | 12 | 0 | 0 | 9 | 36 |
| Increased ALT | 7 | 28 | 7 | 28 | 0 | 0 | 0 | 0 | 9 | 36 |
| Hypotension | 6 | 24 | 5 | 20 | 1 | 4 | 0 | 0 | 10 | 40 |
| Decreased appetite | 5 | 20 | 5 | 20 | 0 | 0 | 0 | 0 | 11 | 44 |
| Increased lipase | 5 | 20 | 4 | 16 | 1 | 4 | 0 | 0 | 5 | 20 |
| Leukopenia | 4 | 16 | 1 | 4 | 3 | 12 | 0 | 0 | 4 | 16 |
| Pyrexia | 4 | 16 | 3 | 12 | 1 | 4 | 0 | 0 | 13 | 52 |
| Acute renal failure | 4 | 16 | 0 | 0 | 2 | 8 | 2 | 8 | 4 | 16 |
| Septic shock | 4 | 16 | 0 | 0 | 3 | 12 | 1 | 4 | 4 | 16 |
| Typhlitis | 3 | 12 | 1 | 4 | 2 | 8 | 0 | 0 | 3 | 12 |
| Coagulopathy | 3 | 12 | 2 | 8 | 1 | 4 | 0 | 0 | 3 | 12 |
| Enterococcal bacteremia | 3 | 12 | 3 | 12 | 0 | 0 | 0 | 0 | 3 | 12 |
| Gingival bleeding | 3 | 12 | 3 | 12 | 0 | 0 | 0 | 0 | 4 | 16 |
| Hyperbilirubinemia | 3 | 12 | 1 | 4 | 2 | 8 | 0 | 0 | 7 | 28 |
| Hypophosphatemia | 3 | 12 | 2 | 8 | 1 | 4 | 0 | 0 | 4 | 16 |
| Nausea | 3 | 12 | 3 | 12 | 0 | 0 | 0 | 0 | 18 | 72 |
| Pulmonary edema | 3 | 12 | 0 | 0 | 2 | 8 | 1 | 4 | 3 | 12 |
| VOD | 3 | 12 | 1 | 4 | 0 | 0 | 2 | 8 | 3 | 12 |
AST indicates aspartate aminotransferase; ALT, alanine aminotransferase; and VOD, veno-occlusive disease (hepatic).