Trial Outcomes & Findings for Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (NCT NCT04191382)
NCT ID: NCT04191382
Last Updated: 2025-09-18
Results Overview
Tumor tissue collected through a core-cut biopsy at Baseline and Day 15 was used to determine Ki67 expression. Ki67 expression was defined as the percentage of positive tumor cells assessed by central reading. Ki67 percent change from Baseline for a given participant was defined as 100\*(Ki67pre - Ki67post) / Ki67pre, where Ki67pre and Ki67post were pre-treatment and post-treatment Ki67 value of the participant. Adjusted geometric least square (LS) means and 95 percentage (%) confidence interval (CI) for the percent change were obtained from analysis of covariance (ANCOVA) model of the log proportional change i.e., log (Ki67post/ki67pre) with treatment and log-Ki67pre as fixed effect and converted by antilog transformation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline, Day 15
Results posted on
2025-09-18
Participant Flow
The study was conducted at 32 active sites in 8 countries. A total of 135 participants were screened from 04-February-2020 to 21-April-2021, of which 30 participants were screen failures mainly due to selection criteria not met.
A total of 105 participants with early breast cancer were randomized in 1:1:1 ratio to receive treatment with amcenestrant 400 milligrams (mg), amcenestrant 200 mg, or letrozole 2.5 mg.
Participant milestones
| Measure |
Amcenestrant 400 mg
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
36
|
35
|
|
Overall Study
Treated
|
33
|
36
|
35
|
|
Overall Study
COMPLETED
|
33
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Amcenestrant 400 mg
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Here, 'Number analyzed' signifies participants with available data at Baseline for the specified Baseline measure.
Baseline characteristics by cohort
| Measure |
Amcenestrant 400 mg
n=34 Participants
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=36 Participants
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=35 Participants
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
Total Title
n=105 Participants
|
|---|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 8.6 • n=34 Participants
|
63.4 years
STANDARD_DEVIATION 8.4 • n=36 Participants
|
63.7 years
STANDARD_DEVIATION 8.5 • n=35 Participants
|
63.2 years
STANDARD_DEVIATION 8.4 • n=105 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=34 Participants
|
36 Participants
n=36 Participants
|
35 Participants
n=35 Participants
|
105 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=34 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=35 Participants
|
10 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=34 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=105 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=34 Participants
|
24 Participants
n=36 Participants
|
25 Participants
n=35 Participants
|
72 Participants
n=105 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=105 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=34 Participants
|
8 Participants
n=36 Participants
|
4 Participants
n=35 Participants
|
20 Participants
n=105 Participants
|
|
Ki67 expression at Baseline
|
33.8 percentage of positive tumor cells
STANDARD_DEVIATION 16.3 • n=32 Participants • Here, 'Number analyzed' signifies participants with available data at Baseline for the specified Baseline measure.
|
31.2 percentage of positive tumor cells
STANDARD_DEVIATION 14.3 • n=36 Participants • Here, 'Number analyzed' signifies participants with available data at Baseline for the specified Baseline measure.
|
32.6 percentage of positive tumor cells
STANDARD_DEVIATION 18.5 • n=32 Participants • Here, 'Number analyzed' signifies participants with available data at Baseline for the specified Baseline measure.
|
32.5 percentage of positive tumor cells
STANDARD_DEVIATION 16.3 • n=100 Participants • Here, 'Number analyzed' signifies participants with available data at Baseline for the specified Baseline measure.
|
PRIMARY outcome
Timeframe: Baseline, Day 15Population: Analysis was performed on modified intent-to-treat (mITT) population that included all enrolled participants for whom there was a confirmation of successful allocation of a randomization number by IRT, who had taken at least one study drug, and who had both Baseline and post treatment available biopsies with Ki67 values.
Tumor tissue collected through a core-cut biopsy at Baseline and Day 15 was used to determine Ki67 expression. Ki67 expression was defined as the percentage of positive tumor cells assessed by central reading. Ki67 percent change from Baseline for a given participant was defined as 100\*(Ki67pre - Ki67post) / Ki67pre, where Ki67pre and Ki67post were pre-treatment and post-treatment Ki67 value of the participant. Adjusted geometric least square (LS) means and 95 percentage (%) confidence interval (CI) for the percent change were obtained from analysis of covariance (ANCOVA) model of the log proportional change i.e., log (Ki67post/ki67pre) with treatment and log-Ki67pre as fixed effect and converted by antilog transformation.
Outcome measures
| Measure |
Amcenestrant 400 mg
n=31 Participants
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=35 Participants
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=29 Participants
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Percent Change From Baseline in Ki67 Level at Day 15
|
75.9 percent change
Interval 67.9 to 81.9
|
68.2 percent change
Interval 58.4 to 75.7
|
77.7 percent change
Interval 70.0 to 83.4
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: Analysis was performed on mITT population.
Tumor tissue collected through a core-cut biopsy at Baseline and Day 15 was used to determine Ki67 expression. Ki67 expression was defined as the percentage of positive tumor cells assessed by central reading. Ki67 percent change from Baseline for a given participant was defined as 100\*(Ki67pre - Ki67post) / Ki67pre, where Ki67pre and Ki67post were pre-treatment and post-treatment Ki67 value of the participant.
Outcome measures
| Measure |
Amcenestrant 400 mg
n=31 Participants
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=35 Participants
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=29 Participants
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Percentage of Participants With Percent Change From Baseline in Ki67 Greater Than or Equal to (>=) 50 Percent at Day 15
|
74.2 percentage of participants
Interval 55.4 to 88.1
|
68.6 percentage of participants
Interval 50.7 to 83.1
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
SECONDARY outcome
Timeframe: Baseline, Day 15Population: Analysis was performed on mITT population. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure.
Change from Baseline in ER expression was measured by H-Score. The H-score was calculated as the sum of the percent of cells staining positive (0 to 100) multiplied staining intensity level from 0 to 3 (0=none, 1=low, 2=moderate, 3=high). Total ER expression H-score ranged from 0 to 300, where higher score indicated stronger ER expression. Change from Baseline in H-Score equals H-scorepost minus H-scorepre; where H-scorepost and H-scorepre denoted post-treatment and pre-treatment H-scores, respectively. LS-means and 95% CI were obtained from an ANCOVA model for change from baseline with treatment and baseline as fixed effect.
Outcome measures
| Measure |
Amcenestrant 400 mg
n=28 Participants
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=32 Participants
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=28 Participants
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Change From Baseline in Estrogen Receptor (ER) Expression as Measured by H-Score at Day 15
|
-176.7 score on a scale
Interval -201.4 to -152.0
|
-202.9 score on a scale
Interval -226.1 to -179.7
|
-32.5 score on a scale
Interval -57.2 to -7.7
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Day 14Population: Analysis was performed on safety population that included all participants who were randomly assigned to study drug and who took at least 1 dose of study drug. Here, 'Number analyzed' signifies participants with available data for each specified category for this outcome measure.
Hematology parameters covered by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and included: Hemoglobin, Lymphocyte, Neutrophils, Leukocytes (white blood cells), Anemia, Platelets, Eosinophils, and international normalized ratio (INR). An NCI-CTCAE Grades 1 to 5 were described as: Grade 1-Mild; asymptomatic/mild symptoms; Grade 2-Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental daily activities. Grade 3-Severe/medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4-Life-threatening consequences; Grade 5-Death. Data for 'All Grades' were reported in this outcome measure.
Outcome measures
| Measure |
Amcenestrant 400 mg
n=33 Participants
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=36 Participants
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=35 Participants
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Number of Participants With Abnormalities: Hematological Parameters
Anemia (hemoglobin decreased)
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
White blood cell decreased
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
Neutrophil count decreased
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
Hemoglobin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
Platelet count decreased
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
Lymphocyte count decreased
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
INR increased
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities: Hematological Parameters
Eosinophilia (eosinophils increased)
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Day 14Population: Analysis was performed on safety population. Here, 'Number analyzed' signifies participants with available data for each specified category for this outcome measure.
Clinical chemistry laboratory parameters covered by NCI-CTCAE and included: Glucose, Potassium, Sodium, Creatinine. An NCI-CTCAE Grades 1 to 5 were described as: Grade 1-Mild; asymptomatic or mild symptoms; Grade 2- Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental daily activities; Grade 3-Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4-Life-threatening consequences; Grade 5-Death. Data for 'All Grades' were reported in this outcome measure.
Outcome measures
| Measure |
Amcenestrant 400 mg
n=33 Participants
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=36 Participants
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=35 Participants
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Number of Participants With Abnormalities: Clinical Chemistry
Hypokalemia (potassium decreased)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities: Clinical Chemistry
Creatinine increased
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities: Clinical Chemistry
Hypernatremia (sodium increased)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities: Clinical Chemistry
Hyponatremia (sodium decreased)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities: Clinical Chemistry
Hyperkalemia (potassium increased)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities: Clinical Chemistry
Hypoglycemia (glucose decreased)
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Amcenestrant 400 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Amcenestrant 200 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Letrozole 2.5 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amcenestrant 400 mg
n=33 participants at risk
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=36 participants at risk
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=35 participants at risk
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/33 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
Other adverse events
| Measure |
Amcenestrant 400 mg
n=33 participants at risk
Participants received 4 capsules of 100 mg of amcenestrant once daily (QD) from Day 1 to Day 14.
|
Amcenestrant 200 mg
n=36 participants at risk
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
|
Letrozole 2.5 mg
n=35 participants at risk
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.0%
1/33 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
5.6%
2/36 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/33 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
8.3%
3/36 • Number of events 3 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
6.1%
2/33 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
5.6%
2/36 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
6.1%
2/33 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.9%
1/35 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
General disorders
Feeling Cold
|
6.1%
2/33 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/36 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
6.1%
2/33 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.0%
1/33 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
5.6%
2/36 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.1%
2/33 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/36 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Number of events 3 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/36 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
5.7%
2/35 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Anxiety
|
3.0%
1/33 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
5.6%
2/36 • Number of events 2 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
12.1%
4/33 • Number of events 4 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/35 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Breast Pain
|
3.0%
1/33 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
0.00%
0/36 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
8.6%
3/35 • Number of events 3 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Hot Flush
|
12.1%
4/33 • Number of events 4 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
2.8%
1/36 • Number of events 1 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
14.3%
5/35 • Number of events 5 • From first dose up to 30 days following the last dose of study drug (up to 45 days)
Reported adverse events (AEs) are treatment-emergent adverse events (TEAEs) i.e., AEs that developed, worsened, or became serious during the treatment period (time from the first dose of study drug up to 30 days after last dose of study drug). Analysis was performed on safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER