Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled phase 3 study of postmenopausal women with osteoporosis

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 disease^a	6 (0.3)	4 (0.2)	15 (0.8)	9 (0.5)
Breast neoplasm^b	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 neoplasia^c	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.
^a P < 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).

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