Table 5 Incidence and Rate per 1,000 Women-Years (95% CI) of VTEs (Adjudicated Data)
Bazedoxifene | Raloxifene | Placebo | ||
|---|---|---|---|---|
20 mg (n = 1886) | 40 mg (n = 1872) | 60 mg (n = 1849) | (n = 1885) | |
Any VTE | ||||
n | 13 | 13 | 9 | 8 |
Year 1 | 8 | 4 | 2 | 3 |
Year 2 | 4 | 6 | 4 | 2 |
Year 3 | 1 | 3 | 3 | 3 |
Rate | 2.8 (1.49, 4.79) | 2.9 (1.54, 4.94) | 2.0 (0.90, 3.74) | 1.7 (0.74, 3.39) |
Year 1 | 4.6 (2.00, 9.14) | 2.4 (0.65, 6.09) | 1.2 (0.14, 4.29) | 1.7 (0.36, 5.05) |
Year 2 | 2.7 (0.73, 6.83) | 4.2 (1.53, 9.05) | 2.7 (0.74, 6.93) | 1.3 (0.16, 4.82) |
Year 3 | 0.7 (0.02, 3.94) | 2.2 (0.45, 6.38) | 2.1 (0.44, 6.22) | 2.1 (0.44, 6.20) |
DVT | ||||
n | 8 | 9 | 7 | 1 |
Rate | 1.7 (0.74, 3.40) | 2.0 (0.92, 3.80) | 1.5 (0.62, 3.15) | 0.2 (0.01, 1.20) |
PE | ||||
n | 3 | 3 | 4 | 4 |
Rate | 0.7 (0.13, 1.89) | 0.7 (0.14, 1.95) | 0.9 (0.24, 2.24) | 0.9 (0.23, 2.20) |
RVT | ||||
n | 2 | 1 | 0 | 3 |
Rate | 0.4 (0.05, 1.56) | 0.2 (0.01, 1.24) | 0 (0.00, 0.66) | 0.7 (0.13, 1.89) |
Superficial thrombophlebitis | ||||
n | 11 | 18 | 13 | 8 |
Rate | 2.4 (1.19, 4.25) | 4.0 (2.38, 6.34) | 2.9 (1.52, 4.87) | 1.7 (0.74, 3.40) |