Table 6.
Incidence of Breast- and Reproductive System-related AEs
| Bazedoxifene | Raloxifene | Placebo | ||
|---|---|---|---|---|
| Subjects, n (%) | 20 mg (n = 1886) |
40 mg (n = 1872) |
60 mg (n = 1849) |
(n = 1885) |
| Breast carcinoma | 6 (0.3) | 4 (0.2) | 7 (0.4) | 8 (0.4) |
| Breast cyst | 8 (0.4) | 10 (0.5) | 17 (0.9) | 11 (0.6) |
| Fibrocystic breast diseasea | 6 (0.3) | 4 (0.2) | 15 (0.8) | 9 (0.5) |
| Breast neoplasmb | 12 (0.6) | 14 (0.7) | 11 (0.6) | 22 (1.2) |
| Breast pain | 53 (2.8) | 45 (2.4) | 56 (3.0) | 48 (2.5) |
| Endometrial carcinoma | 0 | 2 (0.1) | 2 (0.1) | 3 (0.2) |
| Endometrial hyperplasia | 1 (0.1) | 1 (0.1) | 1 (0.1) | 1 (0.1) |
| Endometrial neoplasiac | 9 (0.5) | 12 (0.6) | 12 (0.6) | 10 (0.5) |
| Ovarian carcinoma | 3 (0.2) | 0 | 2 (0.1) | 0 |
| Ovarian cyst | 16 (0.8) | 8 (0.4) | 13 (0.7) | 14 (0.7) |
| Uterine hemorrhage | 3 (0.2) | 5 (0.3) | 4 (0.2) | 3 (0.2) |
| Vaginal hemorrhage | 16 (0.8) | 18 (1.0) | 22 (1.2) | 23 (1.2) |
AE, adverse event.
aP < 0.05; Chi-square test.
bEvents reported as breast neoplasm included breast mass, breast lump, solid formation, lipoma, fibroadenoma, tumor, nodule, microcalcification, intracanalar papilloma, and cyst.
cEvents reported as endometrial neoplasia included endometrial polyps, uterine polyps, thickening of endometrium due to polyps, hyperplastic endometrial polyps, accentuated cystocele and polyps, and endometrial polyps with cystic atrophy (benign).