Table 4.
Drug‐related adverse events occurred in >10% of postmenopausal Japanese women with breast cancer treated with TAS‐108, in either dose group
| Eventa | Dose group | Total (n = 97) | ||||||
|---|---|---|---|---|---|---|---|---|
| 40 mg (n = 33) | 80 mg (n = 32) | 120 mg (n = 32) | ||||||
| All grades, n (%) | Grades 3–5, n (%) | All grades, n (%) | Grades 3–5, n (%) | All grades, n (%) | Grades 3–5, n (%) | All grades, n (%) | Grades 3–5, n (%) | |
| Hot flush | 7 (21.2) | 0 (0) | 8 (25.0) | 0 (0) | 7 (21.9) | 0 (0) | 22 (22.7) | 0 (0) |
| Hyperhidrosis | 2 (6.1) | 0 (0) | 3 (9.4) | 0 (0) | 6 (18.8) | 0 (0) | 11 (11.3) | 0 (0) |
| Nausea | 1 (3.0) | 0 (0) | 3 (9.4) | 0 (0) | 5 (15.6) | 0 (0) | 9 (9.3) | 0 (0) |
| Uterine leiomyoma | 0 (0) | 0 (0) | 4 (12.5) | 0 (0) | 1 (3.1) | 0 (0) | 5 (5.2) | 0 (0) |
| Blood cholesterol increased | 4 (12.1) | 0 (0) | 1 (3.1) | 0 (0) | 0 (0) | 0 (0) | 5 (5.2) | 0 (0) |
a
Patients could have had more than one event.