SPC - Example Only

breast cancer
Non-invasive
cancers
77
(0.5%)
112
(0.8%)
(6.0%) (8.1%) (2.2%) (3.8%) (6.6%) (8.4%)
0.73 (0.61-0.87) 0.57 (0.46-0.70) 0.78 (0.58-1.04)
35
(1.0%)
53
(1.5%)
60
(0.9%)
93
(1.4%)
14
(1.1%)
0.72 (0.57-0.92) 0.65 (0.43-1.00) 0.63 (0.45-0.89) NR
9
(0.7%)
Oestrogen
receptorpositive
219
(1.5%)
396
(2.8%)
160
(4.5%)
238
(6.7%)
70
(1.1%)
182
(2.8%)
53
(4.2%)
86
(7.0%)
cancers 0.56 (0.47-0.67) 0.66 (0.54-0.81) 0.38 (0.28-0.50) 0.61 (0.43-0.86)
Oestrogen
receptornegative
116
(0.8%)
103
(0.7%)
50
(1.4%)
47
(1.3%)
56
(0.8%)
42
(0.6%)
24
(1.9%)
17
(1.4%)
cancers 1.13 (0.86-1.49) 1.05 (0.71-1.57) 1.31 (0.86-2.01) 1.4 (0.7-2.6)
1038
(2.3%*)
All cause
mortality 0·98*
Breast cancer
mortality
30
(0.07%*)
1050
(2.5%*)
(0·90–1·06)
29
(0.07%*)
182
(5.1%)
OR 1·10
166
(4.6%)
(0·88–1·37)
31
(0.9%)
26
(1.0%)
126
(1.9%)
12
(0.2%)
RR 1.10
(0.85-1.43)
114
(1.7%)
11
(0.2%)
54
(4.3%)
12
(1.0%)
0.99
(0.68-1.44)
54
(4.3%)
9
(0.7%)
1.03*
(0.55–1.92)
OR 1.19
(0.68–2.10)
NR
NR
Safety
Events
OR or RR (95% CI)
Endometrial
cancer
67
(0.5%)
31 (0.2%)
OR 2.18 (95% CI
1.39-3.42)
29
(0.8%)
20
(0.6%)
OR 1.45 (95% CI
0.79-2.71)
53
(0.8%)
17
(0.3%)
RR 3.28 (95% CI
1.87-6.03)
13
(1.0%)
NR
5 (0.4%)
787
(1.8%)
Other
cancers OR 0.98*
799
(1.9%)
(95% CI 0.89-1.08)
322
(9.0%)
NR
295
(8.3%)
NR
64
(5.1%)
NR
70
(5.6%)
Venous
thromboembl
ism (DVT,
PE)
131
(0.9%)
82
(0.6%)
104
(2.9%)
62
(1.7%)
DVT 49
(0.7%)
PE 28
(0.4%)
DVT 34
(0.5%)
PE 13
(0.2%)
8
(0.6%)
3
(0.2%)
OR 1.60
(95% CI 1.21-2.12)
OR 1.70
(95% CI 1.22-2.37)
DVT RR 1.44
(95% CI 0.91-2.30)
PE RR 2.15 (95%
CI 1.08-4.51)
Stroke NR 30 28 71 50 7 9
NR