Trial Outcomes & Findings for A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer (NCT NCT01101438)
NCT ID: NCT01101438
Last Updated: 2023-09-13
Results Overview
Invasive disease-free survival (IDFS) is defined as percentage of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3649 participants
Primary outcome timeframe
5 years
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Metformin
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Overall Study
STARTED
|
1824
|
1825
|
|
Overall Study
COMPLETED
|
1816
|
1816
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Metformin
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
Baseline Characteristics
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
Baseline characteristics by cohort
| Measure |
Metformin
n=1824 Participants
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1825 Participants
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
Total
n=3649 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.18 years
STANDARD_DEVIATION 10.05 • n=93 Participants
|
52.56 years
STANDARD_DEVIATION 10.12 • n=4 Participants
|
52.37 years
STANDARD_DEVIATION 10.09 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1821 Participants
n=93 Participants
|
1822 Participants
n=4 Participants
|
3643 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
167 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
1653 Participants
n=93 Participants
|
1651 Participants
n=4 Participants
|
3304 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
599 participants
n=93 Participants
|
604 participants
n=4 Participants
|
1203 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1132 participants
n=93 Participants
|
1127 participants
n=4 Participants
|
2259 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
68 participants
n=93 Participants
|
69 participants
n=4 Participants
|
137 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
|
Body mass index
|
28.72 Kg/m^2
STANDARD_DEVIATION 6.58 • n=93 Participants
|
28.52 Kg/m^2
STANDARD_DEVIATION 6.22 • n=4 Participants
|
28.62 Kg/m^2
STANDARD_DEVIATION 6.40 • n=27 Participants
|
|
Hormone Receptor
Positive
|
1268 Participants
n=93 Participants
|
1265 Participants
n=4 Participants
|
2533 Participants
n=27 Participants
|
|
Hormone Receptor
Negative
|
556 Participants
n=93 Participants
|
560 Participants
n=4 Participants
|
1116 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 yearsInvasive disease-free survival (IDFS) is defined as percentage of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.
Outcome measures
| Measure |
Metformin
n=1268 Participants
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1265 Participants
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Invasive Disease-free Survival in Hormone Receptor (ER and PgR) Positive Sub-groups
|
86.5 percentage of patients without event
Interval 84.5 to 88.5
|
85.9 percentage of patients without event
Interval 83.9 to 87.9
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All randomized patients will be analyzed according to the arm that they were randomized to (intent to treat population).
Invasive disease-free survival (IDFS) is defined as the percent of patients without documented development of ipsilateral and contralateral invasive breast tumour, local/regional invasive recurrence, distant recurrence, death from any causes. If a subject has not had invasive disease or died at the time of data cut-off for this final analysis, IDFS was censored on the date of last follow-up.
Outcome measures
| Measure |
Metformin
n=1824 Participants
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1825 Participants
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Invasive Disease-free Survival
|
84.9 percentage of patients without event
Interval 83.2 to 86.6
|
84.1 percentage of patients without event
Interval 82.4 to 85.8
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Intent to treat
Number of patients who died from any causes.
Outcome measures
| Measure |
Metformin
n=1824 Participants
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1825 Participants
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Overall Survival
Patients who died
|
201 Participants
|
198 Participants
|
|
Overall Survival
Patients who alive
|
1623 Participants
|
1627 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDistant Relapse Free Survival (DRFS) is defined as the percentage of patients without any documented distant recurrence, death from breast cancer, death from a non breast cancer cause or death from an unknown cause. If a subject has not had distant DRFS event nor died at the time of data cut-off for this analysis, DRFS will be censored on the date of last disease assessment.
Outcome measures
| Measure |
Metformin
n=1824 Participants
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1825 Participants
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Distant Relapse-free Survival
|
88.7 percentage of patients without event
Interval 87.2 to 90.2
|
87.8 percentage of patients without event
Interval 86.3 to 89.3
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Intent to treat
Patients who died from breast cancer
Outcome measures
| Measure |
Metformin
n=1824 Participants
Patients receive oral metformin hydrochloride (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1825 Participants
Patients receive oral placebo (850mg) twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Breast Cancer-specific Mortality
|
155 Participants
|
160 Participants
|
Adverse Events
Metformin
Serious events: 1 serious events
Other events: 1707 other events
Deaths: 201 deaths
Placebo
Serious events: 3 serious events
Other events: 1670 other events
Deaths: 198 deaths
Serious adverse events
| Measure |
Metformin
n=1816 participants at risk
Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1816 participants at risk
Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
0.06%
1/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Pregnancy, puerperium and perinatal conditions
Fetal death
|
0.06%
1/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
0.11%
2/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
Other adverse events
| Measure |
Metformin
n=1816 participants at risk
Patients receive oral metformin hydrochloride twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given orally
|
Placebo
n=1816 participants at risk
Patients receive oral placebo twice daily (once daily in weeks 1-4). Treatment continues for up to 5 years in receptor positive (ER and/or PgR positive) subjects in the absence of disease progression or unacceptable toxicity.
placebo: Given orally
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
191/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.0%
146/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Bloating
|
9.9%
179/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.3%
151/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Constipation
|
15.9%
288/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
12.4%
226/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Diarrhea
|
45.1%
819/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
19.5%
354/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Dyspepsia
|
9.6%
174/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
7.8%
141/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Flatulence
|
8.5%
155/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.0%
145/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
121/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
6.3%
114/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Nausea
|
30.8%
560/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
16.4%
297/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
139/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
5.5%
100/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
General disorders
Edema limbs
|
7.9%
143/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
7.2%
130/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
General disorders
Fatigue
|
44.7%
811/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
43.9%
797/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
General disorders
Pain
|
13.8%
250/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
15.2%
276/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
7.0%
127/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
7.6%
138/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Investigations
Weight gain
|
5.0%
90/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.6%
156/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Investigations
Weight loss
|
9.4%
171/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
4.5%
81/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
182/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
4.6%
84/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.4%
80/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
5.1%
93/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
389/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
23.5%
427/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.7%
86/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
5.5%
99/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.6%
211/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
10.4%
189/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
90/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
5.6%
102/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.4%
226/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
13.7%
248/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.1%
328/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
18.3%
332/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Nervous system disorders
Dizziness
|
8.3%
150/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.0%
145/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Nervous system disorders
Dysgeusia
|
5.2%
95/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
3.4%
61/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Nervous system disorders
Headache
|
16.7%
304/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
17.9%
325/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.7%
484/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
28.5%
517/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Psychiatric disorders
Anxiety
|
13.8%
251/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
13.3%
241/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Psychiatric disorders
Depression
|
13.4%
243/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
13.3%
242/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Psychiatric disorders
Insomnia
|
23.0%
417/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
20.9%
380/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Reproductive system and breast disorders
Breast pain
|
6.1%
111/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.0%
145/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
5.5%
99/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
5.5%
99/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
159/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
9.4%
171/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
165/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
9.4%
170/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.7%
194/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
8.8%
159/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Vascular disorders
Hot flashes
|
39.4%
716/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
38.9%
706/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Vascular disorders
Hypertension
|
11.4%
207/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
12.5%
227/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
|
Vascular disorders
Lymphedema
|
9.4%
171/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
9.8%
178/1816 • 10 years
For all cause mortality, the analysis population is intent to treat, which includes all randomized patients. This is different from the analysis population for the adverse event and serious adverse event (treated population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place