Table 3.
Treatment-related adverse events (as-treated population)
| TAS-114/S-1 (n = 64) |
S-1 (n = 63) |
|||
|---|---|---|---|---|
| All Grades | ≥Grade 3 | All Grades | ≥Grade 3 | |
| Event | n (%) | n (%) | n (%) | n (%) |
| All | 60 (93.8) | 35 (54.7) | 57 (90.5) | 10 (15.9) |
| Hematology | ||||
| Anemia | 37 (57.8) | 14 (21.9) | 10 (15.9) | 0 |
| White blood cell count decreased | 10 (15.6) | 2 (3.1) | 5 (7.9) | 0 |
| Platelet count decreased | 8 (12.5) | 1 (1.6) | 6 (9.5) | 0 |
| Neutrophil count decreased | 6 (9.4) | 2 (3.1) | 7 (11.1) | 1 (1.6) |
| Non-hematology | ||||
| Decreased appetite | 25 (39.1) | 3 (4.7) | 22 (34.9) | 1 (1.6) |
| Nausea | 20 (31.3) | 0 | 20 (31.7) | 1 (1.6) |
| Diarrhea | 18 (28.1) | 2 (3.1) | 12 (19.0) | 1 (1.6) |
| Skin hyperpigmentation | 18 (28.1) | 0 | 11 (17.5) | 0 |
| Maculo-papular rash | 18 (28.1) | 4 (6.3) | 2 (3.2) | 0 |
| Asthenia | 17 (26.6) | 4 (6.3) | 9 (14.3) | 2 (3.2) |
| Rash | 15 (23.4) | 5 (7.8) | 3 (4.8) | 0 |
| Vomiting | 10 (15.6) | 0 | 11 (17.5) | 2 (3.2) |
| Pruritus | 10 (15.6) | 0 | 7 (11.1) | 0 |
| Stomatitis | 9 (14.1) | 1 (1.6) | 4 (6.3) | 0 |
| Malaise | 8 (12.5) | 0 | 5 (7.9) | 0 |
| Fatigue | 6 (9.4) | 1 (1.6) | 9 (14.3) | 1 (1.6) |
| Dry skin | 9 (14.1) | 0 | 5 (7.9) | 0 |