Table 2.

Summary of key safety findings for BZA

Parameter	Global prevention study (N = 1,583)	Global treatment study (N = 7,492)	Japanese phase 2 study (N = 429)
Overall safety/tolerability	• Similar AE rates compared with placebo [85]	• Similar AE rates among groups [88, 90, 93]	• Similar AE rates among groups [94]
Cardiac events	• No cardiac safety concerns [85]	• Incidence was low and similar among groups [88, 90]	• Incidence was low and similar among groups [94]
Cerebrovascular events	• Incidence was low and similar among groups [85]	• Incidence was low and similar among groups [88, 90]	• Incidence was low and similar among groups [94]
VTEs	• Incidence was low and similar among groups [85]	• Higher incidences for BZA versus placebo [88, 90, 93]	• No cases reported [94]
Endometrial safety	• No differences among groups in change in endometrial thickness [86] • No confirmed cases of endometrial carcinoma or hyperplasia [86]	• No differences among groups in change in endometrial thickness [87, 90, 92] • Incidences of endometrial hyperplasia were low and similar among groups [87, 90, 92]	• No differences among groups in change in endometrial thickness [94] • No cases of endometrial carcinoma or hyperplasia reported [94]
		• Lower incidences of endometrial carcinoma with BZA versus placebo (overall p < 0.05) [90, 92]
Breast safety	• Incidence of breast-related AEs was low and similar among groups [86]	• Incidence of breast-related AEs was low and similar among groups [87, 90, 92]	• Incidence of breast-related AEs was low and similar among groups [94]
Other reproductive safety	• No other reproductive safety concerns [86]	• Numerically higher incidence of ovarian carcinoma for BZA versus placebo (not statistically significant) [90, 92] • No other reproductive safety concerns [87, 90, 92]	• No other reproductive safety concerns [94]

BZA bazedoxifene, AE adverse event, VTE venous thromboembolic event