Table 3.
Incidence of drug-related adverse events (safety population), by grade of severity, during induction and maintenance
| Adverse event | Induction (n = 40) | Maintenance (n = 29) |
|---|---|---|
| Leukopenia | ||
| Grade 1–2 | 7 (17.5) | 4 (14) |
| Grade 3 | 1 (2.5) | 1 (3.5) |
| Grade 4 | – | – |
| Neutropenia | ||
| Grade 1–2 | 8 (20) | 4 (14) |
| Grade 3 | 1 (2.5) | 2 (7) |
| Grade 4 | – | – |
| Thrombocytopenia | ||
| Grade 1–2 | 9 (22.5) | 7 (24) |
| Grade 3 | 2 (5) | 2 (7) |
| Grade 4 | – | – |
| Anemia | ||
| Grade 1–2 | 6 (15) | 2 (7) |
| Grade 3 | 1 (2.5) | – |
| Grade 4 | – | – |
| Nausea | ||
| Grade 1–2 | 5 (12.5) | 3 (10) |
| Grade 3 | – | – |
| Grade 4 | – | – |
| Vomiting | ||
| Grade 1–2 | 4 (10) | 3 (10) |
| Grade 3 | – | – |
| Grade 4 | – | – |
| Cutaneous rush | ||
| Grade 1–2 | 2 (5) | – |
| Grade 3 | – | – |
| Grade 4 | – | – |
| Metabolic/laboratory AST/ALT | ||
| Grade 1–2 | 3 (7.5) | 7 (24) |
| Grade 3 | – | 3 (10) |
| Grade 4 | – | – |
AST aspartate transaminase, ALT alanine transaminase