Table 3 Adverse events in the All-Patients-Treated Set
Adverse event | Grades 1–2 | Grades 3–4 | ||||
|---|---|---|---|---|---|---|
D-SOX (n = 39)% | DOS (n = 39)% | P | D-SOX (n = 39)% | DOS (n = 39)% | P | |
Leukopenia | 23 (59%) | 19 (49%) | 0.36 | 8 (20%) | 18 (46%) | 0.02 |
Neutropenia | 18 (46%) | 16 (41%) | 0.48 | 10 (26%) | 21 (54%) | 0.01 |
Anemia | 30 (77%) | 28 (72%) | 0.60 | 5 (13%) | 8 (21%) | 0.36 |
Thrombocytopenia | 12 (31%) | 15 (38%) | 0.47 | 2 (5%) | 2 (5%) | 1.00 |
Febrile neutropenia | – | – | – | 1 (3%) | 3 (8%) | 0.61 |
Nausea | 18 (46%) | 21 (54%) | 0.49 | 2 (5%) | 4 (10%) | 0.67 |
Vomiting | 11 (28%) | 16 (41%) | 0.23 | 2 (5%) | 3 (8%) | 1.00 |
Diarrhea | 15 (38%) | 17 (44%) | 0.65 | 2 (5%) | 1 (3%) | 1.00 |
Anorexia | 25 (64%) | 23 (59%) | 0.64 | 4 (10%) | 6 (15%) | 0.5 |
Fatigue | 22 (56%) | 25 (64%) | 0.48 | 2 (5%) | 3 (8%) | 1.00 |
AST increased | 5 (13%) | 8 (21%) | 0.36 | 1 (3%) | 1 (3%) | 1.00 |
ALT increased | 8 (21%) | 10 (26%) | 0.59 | 1 (3%) | 1 (3%) | 1.00 |
Creatinine increased | 6 (15%) | 8 (21%) | 0.55 | 0 | 0 | – |
Peripheral sensory neuropathy | 15 (38%) | 19 (49%) | 0.36 | 0 | 0 | – |
Rash maculopapular | 3 (8%) | 5 (13%) | 0.71 | 0 | 0 | – |
Skin hyperpigmentation | 15 (38%) | 14 (36%) | 0.82 | 0 | 0 | – |
Mucositis oral | 13 (33%) | 16 (41%) | 0.48 | 0 | 0 | – |