Table 5.
Adverse drug reactions occurring in ≥3% of patients
| <65 years (n = 146) |
≥65 years (n = 108) |
ALL (N = 254) |
||||
|---|---|---|---|---|---|---|
| All grade | Grade ≥3 | All grade | Grade ≥3 | All grade | Grade ≥3 | |
| Any | 120 (82.2) | 103 (70.5) | 92 (85.2) | 76 (70.4) | 212 (83.5) | 179 (70.5) |
| Hematological toxicity | ||||||
| Neutropenia | 82 (56.2) | 73 (50.0) | 72 (66.7) | 64 (59.3) | 154 (60.6) | 137 (53.9) |
| Leukopenia | 84 (57.5) | 67 (45.9) | 66 (61.1) | 54 (50.0) | 150 (59.1) | 121 (47.6) |
| Lymphopenia | 26 (17.8) | 24 (16.4) | 14 (13.0) | 14 (13.0) | 40 (15.7) | 38 (15.0) |
| Anemia | 14 (9.6) | 10 (6.8) | 16 (14.8) | 10 (9.3) | 30 (11.8) | 20 (7.9) |
| Thrombocytopenia | 7 (4.8) | 4 (2.7) | 2 (1.9) | 1 (0.9) | 9 (3.5) | 5 (2.0) |
| Febrile neutropenia | 3 (2.1) | 3 (2.1) | 6 (5.6) | 6 (5.6) | 9 (3.5) | 9 (3.5) |
| Non-hematological toxicity | ||||||
| Peripheral neuropathy | 18 (12.3) | 2 (1.4) | 12 (11.1) | 3 (2.8) | 30 (11.8) | 5 (2.0) |
| Stomatitis | 5 (3.4) | 0 | 4 (3.7) | 1 (1.0) | 9 (3.5) | 1 (0.4) |
| Alopeciaa | 7 (4.8) | – | 4 (3.7) | – | 11 (4.3) | – |
| Malaise | 8 (5.5) | 1 (0.7) | 5 (4.6) | 0 | 13 (5.1) | 1 (0.4) |
| Pyrexia | 7 (4.8) | 0 | 2 (1.9) | 0 | 9 (3.5) | 0 |
| Laboratory test abnormalities | ||||||
| ALT-increased | 23 (15.8) | 3 (2.1) | 10 (9.3) | 0 | 33 (13.0) | 3 (1.2) |
| AST-increased | 20 (13.7) | 2 (1.4) | 12 (11.1) | 0 | 32 (12.6) | 2 (0.8) |
| γ-GTP increased | 11 (7.5) | 8 (5.5) | 2 (1.9) | 1 (0.9) | 13 (5.1) | 9 (3.5) |
| CRP increased | 8 (5.5) | 2 (1.4) | 9 (8.3) | 5 (4.6) | 17 (6.7) | 7 (2.8) |
| Hemoglobin decreased | 10 (6.8) | 4 (2.7) | 2 (1.9) | 2 (1.9) | 12 (4.7) | 6 (2.4) |
Data are presented as n (%). ALT alanine aminotransferase, AST aspartate aminotransferase, CRP C-reactive protein, GTP glutamyl transferase
a Grading for alopecia is not available as indicated by ‘-‘