Table 2.
Drug-related adverse events
| S-1 (n = 569) |
Docetaxel (n = 560) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Any grade | Grade 3–4 | Any grade | Grade 3–4 | |||||
| Decreased appetite | 287 | (50.4) | 37 | (6.5) | 204 | (36.4) | 15 | (2.7) |
| Nausea | 207 | (36.4) | 5 | (0.9) | 149 | (26.6) | 8 | (1.4) |
| Diarrhea | 204 | (35.9) | 36 | (6.3) | 92 | (16.4) | 6 | (1.1) |
| Skin hyperpigmentation | 178 | (31.3) | 0 | (0) | 11 | (2.0) | 0 | (0) |
| Stomatitis | 133 | (23.4) | 14 | (2.5) | 80 | (14.3) | 5 | (0.9) |
| Vomiting | 106 | (18.6) | 9 | (1.6) | 64 | (11.4) | 4 | (0.7) |
| Malaise | 105 | (18.5) | 1 | (0.2) | 131 | (23.4) | 4 | (0.7) |
| Fatigue | 95 | (16.7) | 7 | (1.2) | 106 | (18.9) | 5 | (0.9) |
| Neutropenia | 85 | (14.9) | 31 | (5.4) | 307 | (54.8) | 267 | (47.7) |
| Constipation | 70 | (12.3) | 1 | (0.2) | 92 | (16.4) | 1 | (0.2) |
| Anemia | 69 | (12.1) | 15 | (2.6) | 53 | (9.5) | 8 | (1.4) |
| Weight decreased | 69 | (12.1) | 3 | (0.5) | 20 | (3.6) | 0 | (0) |
| Thrombocytopenia | 63 | (11.1) | 7 | (1.2) | 13 | (2.3) | 1 | (0.2) |
| Rash maculo-papular | 59 | (10.4) | 5 | (0.9) | 45 | (8.0) | 1 | (0.2) |
| Leukocytopenia | 54 | (9.5) | 7 | (1.2) | 246 | (43.9) | 163 | (29.1) |
| Peripheral sensory neuropathy | 23 | (4.0) | 1 | (0.2) | 87 | (15.5) | 4 | (0.7) |
| Edema peripheral | 13 | (2.3) | 0 | (0) | 88 | (15.7) | 5 | (0.9) |
| Alopecia | 11 | (1.9) | 0 | (0) | 261 | (46.6) | 0 | (0) |
| Febrile neutropenia | 5 | (0.9) | 5 | (0.9) | 75 | (13.4) | 75 | (13.4) |
Data are n (%). Drug-related adverse events occurring in 10% or more of patients in either arm are shown. Treatment-related deaths were observed: disseminated intravascular coagulation and ileus in the docetaxel arm, hypovolemic shock in the S-1 arm.