Table 3: Adverse Events in 4 Randomized Controlled Trials of Breast Cancer Chemoprevention
| Outcomes |
Study |
No. of Events (n) |
Cumulative Rate/1,000 Women |
Relative Risk
(95% CI) |
| Placebo |
Treatment |
Pleacebo |
Treatment |
| Endometrial Cancer |
BCPT1 |
15 |
36 |
0.91 |
2.30 |
2.53(1.35-4.97) |
| <50 y old |
8 |
9 |
1.09 |
1.32 |
1.21(0.41-3.60) |
| >50 y old |
7 |
27 |
0.76 |
3.05 |
4.01(1.70-10.90) |
| RMH2 |
1 |
4 |
NA |
NA |
NA |
| MORE3 |
4 |
6 |
NA |
NA |
0.8(0.2-2.7) |
| Stroke |
BCPT |
24 |
38 |
0.92 |
1.45 |
1.59(0.93-2.77) |
| <50 y old |
4 |
3 |
0.39 |
0.30 |
0.76(0.11-4.49) |
| >50 y old |
20 |
35 |
1.26 |
2.20 |
1.75(0.98-3.20) |
| Italian4 |
0 |
5 |
NA |
NA |
NA |
| Pulmonary Embolism |
BCPT |
6 |
18 |
0.23 |
0.69 |
3.01(1.15-9.27) |
| <50 y old |
1 |
2 |
0.10 |
0.20 |
2.03(0.11-119.62) |
| >50 y old |
5 |
16 |
0.31 |
1.00 |
3.19(1.12-11.15) |
| RMH |
2 |
3 |
NA |
NA |
NA |
| Italian |
1 |
1 |
NA |
NA |
NA |
| MORE |
3 |
10 |
NA |
NA |
3.1(1.5-6.2)5 |
| Deep Vein Thrombosis |
BCPT |
22 |
35 |
0.84 |
1.34 |
1.60(0.91-2.86) |
| <50 y old |
8 |
11 |
0.78 |
1.08 |
1.39(0.51-3.99) |
| >50 y old |
14 |
24 |
0.88 |
1.51 |
1.71(0.85-3.58) |
| RMH |
2 |
4 |
NA |
NA |
NA |
| Italian |
3 |
6 |
NA |
NA |
NA |
| MORE |
5 |
18 |
NA |
NA |
3.1(1.5-6.2)5 |
CI, Confidence Interval; NA, Data not available.
1BCPT, Breast Cancer Prevention Trial (20).
2RMH, Royal Marsden Hospital Tamoxifen Chemoprevention Trial (19).
3MORE, Multiple Outcomes of Raloxifene Evaluation (22).
4Italian, Italian Tamoxifen Prevention Study (21).
5Results reported for pulmonary embolism and deep vein thrombosis combined.
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