Table 3.
Adverse drug reactions occurring in ≥3% of patients
| Adverse drug reactions (N = 255) | ||
|---|---|---|
| All grades | ≥Grade 3 | |
| Any | 211 (82.7) | 174 (68.2) |
| Hematological toxicity | ||
| Neutropenia | 149 (58.4) | 134 (52.5) |
| Leukopenia | 147 (57.7) | 118 (46.3) |
| Lymphopenia | 38 (14.9) | 37 (14.5) |
| Anemia | 25 (9.8) | 17 (6.7) |
| Thrombocytopenia | 9 (3.5) | 5 (2.0) |
| Febrile neutropenia | 8 (3.1) | 8 (3.1) |
| Non-hematological toxicity | ||
| Neuropathy peripheral | 24 (9.4) | 4 (1.6) |
| Malaise | 11 (4.3) | 1 (0.4) |
| Alopecia | 11 (4.3) | |
| Pyrexia | 8 (3.1) | |
| Laboratory test abnormalities | ||
| ALT increase | 32 (12.6) | 3 (1.2) |
| AST increase | 31 (12.2) | 2 (0.8) |
| CRP increase | 17 (6.7) | 7 (2.7) |
| γ-GT increase | 12 (4.7) | 8 (3.1) |
| Hemoglobin decrease | 12 (4.7) | 6 (2.4) |
Safety analysis set, n (%).
Safety information was collected for any grade for priority AEs and AEs resulting in drug withdrawal and for ≥grade 3 for all other AEs.
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CRP, c-reactive protein; γ-GT, γ-glutamyl transferase.