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Table 4 HR (95% CI) Versus Placebo for Cerebrovascular Events and VTEs (Adjudicated Data)

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

 

Bazedoxifene

Raloxifene

 

20 mg

(n = 1886)

40 mg

(n = 1872)

60 mg

(n = 1849)

Total stroke

0.9 (0.40, 1.86)

1.0 (0.49, 2.17)

0.9 (0.40, 1.88)

   Hemorrhagic stroke

0.5 (0.05, 5.53)

0.5 (0.05, 5.70)

0.5 (0.05, 5.65)

   Ischemic stroke

0.9 (0.37, 2.22)

1.2 (0.54, 2.87)

1.0 (0.42, 2.44)

   Stroke (unspecified)

1.0 (0.14, 7.10)

0.5 (0.05, 5.74)

0.5 (0.05, 5.54)

TIA

1.3 (0.34, 4.68)

1.8 (0.53, 6.18)

0.8 (0.17, 3.41)

Any VTE

1.6 (0.68, 3.94)

1.7 (0.70, 4.07)

1.1 (0.44, 2.96)

   DVT

8.0 (1.01, 64.25)

9.4 (1.18, 73.82)

7.1 (0.88, 57.95)

   PE

0.8 (0.17, 3.36)

0.8 (0.17, 3.47)

1.0 (0.25, 4.08)

   RVT

0.7 (0.11, 4.00)

0.4 (0.04, 3.32)

0

Superficial thrombophlebitis

1.4 (0.55, 3.43)

2.3 (1.01, 5.33)

1.7 (0.68, 3.99)

  1. HR, hazard ratio; CI, confidence interval; VTE, venous thromboembolic event; TIA, transient ischemic attack; DVT, deep vein thrombosis; PE, pulmonary embolus; RVT, retinal vein thrombosis.