Skip to main content
. Author manuscript; available in PMC: 2016 Jan 31.
Published in final edited form as: Menopause. 2015 Feb;22(2):185–197. doi: 10.1097/GME.0000000000000280

Table 3.

Adverse Events for Major System, by Site and Treatmenta

AE System Site Treatment Rateb Count Exposure Site effect
(p value)		 Treatment effect
(p value)
Cardiovascular ISU Placebo 0.050 2 120.00 0.67 0.68
80 mg/d 0.049 2 123.00
120 mg/d 0.102 4 117.50
UCD Placebo 0.053 2 113.50
80 mg/d 0.125 5 120.00
120 mg/d 0.056 2 107.75
Endocrine ISU Placebo 0.325 13 120.00 0.091 0.38
80 mg/d 0.122 5 123.00
120 mg/d 0.255 10 117.50
UCD Placebo 0.132 6 113.50
80 mg/d 0.150 6 120.00
120 mg/d 0.111 4 107.75
Gastrointestinal ISU Placebo 0.450 18 120.00 0.50 0.25
80 mg/d 0.683 28 123.00
120 mg/d 0.383 15 117.50
UCD Placebo 0.423 16 113.50
80 mg/d 0.450 18 120.00
120 mg/d 0.418 15 107.75
Genitourinary ISU Placebo 0.150 6 120.00 0.78 0.005
80 mg/d 0.366 15 123.00
120 mg/d 0.128 5 117.50
UCD Placebo 0.185 7 113.50
80 mg/d 0.300 12 120.00
120 mg/d 0.084 3 107.75
Gynecologic ISU Placebo 0.250 10 120.00 0.085 0.32
80 mg/d 0.537 22 123.00
120 mg/d 0.255 10 117.50
UCD Placebo 0.238 9 113.50
80 mg/d 0.175 7 120.00
120 mg/d 0.251 9 107.75
Hematologic ISU Placebo 0.300 12 120.00 0.33 0.084
80 mg/d 0.268 11 123.00
120 mg/d 0.409 16 117.50
UCD Placebo 0.106 4 113.50
80 mg/d 0.250 10 120.00
120 mg/d 0.390 14 107.75
Metabolic ISU Placebo 0.450 18 120.00 0.51 0.69
80 mg/d 0.415 17 123.00
120 mg/d 0.664 26 117.50
UCD Placebo 0.582 22 113.50
80 mg/d 0.425 17 120.00
120 mg/d 0.278 10 107.75
Nervous ISU Placebo 0.300 12 120.00 0.97 0.99
80 mg/d 0.244 10 123.00
120 mg/d 0.102 4 117.50
UCD Placebo 0.132 5 113.50
80 mg/d 0.175 7 120.00
120 mg/d 0.334 12 107.75
Nonspecific ISU Placebo 1.050 42 120.00 0.31 0.88
80 mg/d 0.854 35 123.00
120 mg/d 1.302 51 117.50
UCD Placebo 0.846 32 113.50
80 mg/d 1.075 43 120.00
120 mg/d 0.752 27 107.75
Ophthalmic ISU Placebo 0.050 2 120.00 0.29 0.18
80 mg/d 0.073 3 123.00
120 mg/d 0.128 5 117.50
UCD Placebo 0.079 3 113.50
80 mg/d 0.100 4 120.00
120 mg/d 0.195 7 107.75
Pathological ISU Placebo 0.850 34 120.00 0.0017 0.13
80 mg/d 0.512 21 123.00
120 mg/d 0.511 20 117.50
UCD Placebo 0.344 13 113.50
80 mg/d 0.250 10 120.00
120 mg/d 0.390 14 107.75
Pulmonary ISU Placebo 2.250 90 120.00 ≤0.0001 0.83
80 mg/d 1.610 66 123.00
120 mg/d 1.736 68 117.50
UCD Placebo 0.449 17 113.50
80 mg/d 0.975 39 120.00
120 mg/d 0.780 28 107.75
Renal ISU Placebo 0 0 120.00 0.92 0.77
80 mg/d 0.024 1 123.00
120 mg/d 0.026 1 117.50
UCD Placebo 0.026 1 113.50
80 mg/d 0 0 120.00
120 mg/d 0.028 1 107.75
Skin ISU Placebo 0.275 11 120.00 0.72 0.36
80 mg/d 0.146 6 123.00
120 mg/d 0.281 11 117.50
UCD Placebo 0.185 7 113.50
80 mg/d 0.175 7 120.00
120 mg/d 0.251 9 107.75
a

Results were obtained by fitting a Poisson regression model with an extra dispersion parameter that links the natural logarithms of rates of occurrence of AEs to treatment and site effects.

b

Incidence rates are calculated using the expected counts divided by exposure time. For women who completed the entire study, exposure time=36 mo; for women who dropped out, exposure time=time point when woman was last examined plus ½ of next time interval.

HHS Vulnerability Disclosure