Adverse events
| Adverse event . | Induction (A1; n = 81) . | Consolidation (B1; n = 78) . | Consolidation (C1; n = 70) . | Consolidation (A2; n = 62) . | Consolidation (B2; n = 58) . | Consolidation (C2; n = 50) . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Allergic/hypersensitivity | 0 | 0 | 0 | 1 1.3% | 1 1.3% | 0 | 0 | 1 1.4% | 0 | 1 1.6% | 1 1.6% | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AST/ALT | 21 25.9% | 2 2.5% | 0 | 4 5.1% | 0 | 0 | 1 1.4% | 0 | 0 | 5 6.5% | 1 1.6% | 0 | 0 | 0 | 0 | 3 6.0% | 0 | 0 |
| Bilirubin | 8 9.9% | 1 1.2% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Febrile neutropenia | 20 24.7% | 1 1.2% | 0 | 25 32.0% | 1 1.3% | 0 | 8 11.4% | 0 | 0 | 12 19.4% | 0 | 0 | 16 27.6% | 1 1.7% | 0 | 5 10.0% | 0 | 0 |
| Infection | 13 16.0% | 2 2.5% | 0 | 13 16.7% | 0 | 1 1.3% | 3 4.3% | 0 | 0 | 6 9.7% | 0 | 0 | 9 15.5% | 3 5.2% | 0 | 2 4.0% | 0 | 0 |
| Stomatitis | 1 1.2% | 0 | 0 | 0 | 0 | 0 | 4 5.7% | 0 | 0 | 0 | 0 | 0 | 1 1.7% | 0 | 0 | 1 2.0% | 0 | 0 |
| Pancreatitis | 1 1.2% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypofibrinogenemia | 21 25.9% | 2 2.5% | 0 | 0 | 0 | 0 | 2 2.9% | 0 | 0 | 10 16.0% | 1 1.6% | 0 | 0 | 0 | 0 | 2 4.0% | 0 | 0 |
| Peripheral neuropathy | 4 4.9% | 0 | 0 | 2 2.6% | 0 | 0 | 4 5.7% | 0 | 0 | 3 4.8% | 0 | 0 | 2 3.4% | 0 | 0 | 5 10.0% | 0 | 0 |
| Creatinine | 0 | 0 | 0 | 0 | 0 | 0 | 3 4.3% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cardiac | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse event . | Induction (A1; n = 81) . | Consolidation (B1; n = 78) . | Consolidation (C1; n = 70) . | Consolidation (A2; n = 62) . | Consolidation (B2; n = 58) . | Consolidation (C2; n = 50) . | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | Grade 3 . | Grade 4 . | Grade 5 . | |
| Allergic/hypersensitivity | 0 | 0 | 0 | 1 1.3% | 1 1.3% | 0 | 0 | 1 1.4% | 0 | 1 1.6% | 1 1.6% | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AST/ALT | 21 25.9% | 2 2.5% | 0 | 4 5.1% | 0 | 0 | 1 1.4% | 0 | 0 | 5 6.5% | 1 1.6% | 0 | 0 | 0 | 0 | 3 6.0% | 0 | 0 |
| Bilirubin | 8 9.9% | 1 1.2% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Febrile neutropenia | 20 24.7% | 1 1.2% | 0 | 25 32.0% | 1 1.3% | 0 | 8 11.4% | 0 | 0 | 12 19.4% | 0 | 0 | 16 27.6% | 1 1.7% | 0 | 5 10.0% | 0 | 0 |
| Infection | 13 16.0% | 2 2.5% | 0 | 13 16.7% | 0 | 1 1.3% | 3 4.3% | 0 | 0 | 6 9.7% | 0 | 0 | 9 15.5% | 3 5.2% | 0 | 2 4.0% | 0 | 0 |
| Stomatitis | 1 1.2% | 0 | 0 | 0 | 0 | 0 | 4 5.7% | 0 | 0 | 0 | 0 | 0 | 1 1.7% | 0 | 0 | 1 2.0% | 0 | 0 |
| Pancreatitis | 1 1.2% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypofibrinogenemia | 21 25.9% | 2 2.5% | 0 | 0 | 0 | 0 | 2 2.9% | 0 | 0 | 10 16.0% | 1 1.6% | 0 | 0 | 0 | 0 | 2 4.0% | 0 | 0 |
| Peripheral neuropathy | 4 4.9% | 0 | 0 | 2 2.6% | 0 | 0 | 4 5.7% | 0 | 0 | 3 4.8% | 0 | 0 | 2 3.4% | 0 | 0 | 5 10.0% | 0 | 0 |
| Creatinine | 0 | 0 | 0 | 0 | 0 | 0 | 3 4.3% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cardiac | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase.