Trial Outcomes & Findings for Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue (NCT NCT03199963)
NCT ID: NCT03199963
Last Updated: 2022-07-26
Results Overview
Percent MBD at screening compared to percent MBD after 52 weeks of treatment with either BHR-700 or Placebo.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
223 participants
Primary outcome timeframe
Blinded Phase: Baseline; Week 52
Results posted on
2022-07-26
Participant Flow
Participant milestones
| Measure |
BHR-700 (0.2% 4-OHT Gel)
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
|---|---|---|
|
Blinded Phase - Overall Study
STARTED
|
149
|
74
|
|
Blinded Phase - Overall Study
Received at Least 1 Gel Application
|
149
|
73
|
|
Blinded Phase - Overall Study
COMPLETED
|
16
|
8
|
|
Blinded Phase - Overall Study
NOT COMPLETED
|
133
|
66
|
|
Optional Open-Label Phase - BHR-700
STARTED
|
7
|
6
|
|
Optional Open-Label Phase - BHR-700
COMPLETED
|
0
|
0
|
|
Optional Open-Label Phase - BHR-700
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
BHR-700 (0.2% 4-OHT Gel)
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
|---|---|---|
|
Blinded Phase - Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Blinded Phase - Overall Study
Lost to Follow-up
|
9
|
2
|
|
Blinded Phase - Overall Study
Adverse Event
|
10
|
5
|
|
Blinded Phase - Overall Study
Study was terminated early by the Sponsor for administrative reasons.
|
109
|
54
|
|
Optional Open-Label Phase - BHR-700
Study terminated early by Sponsor for administrative reasons; data contribution was negligible.
|
7
|
5
|
|
Optional Open-Label Phase - BHR-700
Adverse Event
|
0
|
1
|
Baseline Characteristics
Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue
Baseline characteristics by cohort
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=149 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
n=74 Participants
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
54.9 years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
132 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 participants
n=5 Participants
|
71 participants
n=7 Participants
|
211 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blinded Phase: Baseline; Week 52Population: Study was terminated early for administrative and not safety reasons; an abbreviated clinical study report was prepared and results were limited to safety parameters only. This outcome was not collected and therefore cannot be reported.
Percent MBD at screening compared to percent MBD after 52 weeks of treatment with either BHR-700 or Placebo.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Blinded Phase: Baseline; Weeks 13, 26, 39, 52/EOS and Open Label PhasePopulation: A total of 223 subjects were enrolled in this study; 222 subjects were randomized to the study treatment and received at least one dose of study drug.
AEs monitored and reported throughout study
Outcome measures
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=149 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
n=73 Participants
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
n=7 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
n=6 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Number and Severity of Adverse Events (AEs)
Subjects with at least one mild AE
|
56 Participants
|
31 Participants
|
2 Participants
|
1 Participants
|
|
Number and Severity of Adverse Events (AEs)
Subjects with at least one moderate AE
|
49 Participants
|
29 Participants
|
2 Participants
|
1 Participants
|
|
Number and Severity of Adverse Events (AEs)
Subjects with at least one severe AE
|
8 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Blinded Phase: Baseline; Week 52/EOSPopulation: This parameter captures data from Week 52 or End of Study for subjects who stopped treatment at various timepoints before the 52 weeks.
SHBG levels at baseline will be compared to levels at Week 52/EOS
Outcome measures
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=111 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
n=56 Participants
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Change in Serum Concentration of Sex Hormone Binding Globulin (SHBG) From Baseline to Week 52/End of Study (EOS)
|
0.1 mg/L
Standard Deviation 1.6
|
0.3 mg/L
Standard Deviation 1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Blinded Phase: Baseline; Weeks 26, 52/EOS.Population: Study was terminated early for administrative and not safety reasons; an abbreviated clinical study report was prepared and results were limited to safety and pharmacokinetic (PK)/pharmacodynamic (PD) parameters only. Of all subjects that attended the Week 52/End of Study visit, only 24 subjects completed 52 weeks of treatment. All other subjects stopped treatment at various timepoints before the 52 weeks.
Lipid levels at baseline will be compared to levels measured at time-points in the study
Outcome measures
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=148 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
n=73 Participants
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
Cholesterol (mmol/L) - Change from Baseline to Week 26
|
-0.1 mmol/L
Standard Deviation 0.6
|
-0.2 mmol/L
Standard Deviation 0.7
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
Cholesterol (mmol/L) - Change from Baseline to Week 52/EOS
|
0.1 mmol/L
Standard Deviation 0.7
|
0.0 mmol/L
Standard Deviation 0.7
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
Triglycerides (mmol/L) - Change from Baseline to Week 26
|
-0.2 mmol/L
Standard Deviation 1.2
|
-0.2 mmol/L
Standard Deviation 0.6
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
Triglycerides (mmol/L) - Change from Baseline to Week 52/EOS
|
-0.1 mmol/L
Standard Deviation 0.8
|
0.0 mmol/L
Standard Deviation 0.8
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
HDL Cholesterol (mmol/L) - Change from Baseline to Week 26
|
-0.0 mmol/L
Standard Deviation 0.3
|
0.0 mmol/L
Standard Deviation 0.2
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
HDL Cholesterol (mmol/L) - Change from Baseline to Week 52/EOS
|
0.0 mmol/L
Standard Deviation 0.2
|
0.0 mmol/L
Standard Deviation 0.3
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
LDL Cholesterol (mmol/L) - Change from Baseline to Week 26
|
0.0 mmol/L
Standard Deviation 0.6
|
-0.1 mmol/L
Standard Deviation 0.7
|
—
|
—
|
|
Change in Serum Concentration of: Cholesterol, Triglycerides, High-density Lipoprotein (HDL), and Low-density Lipoprotein (LDL).
LDL Cholesterol (mmol/L) - Change from Baseline to Week 52/EOS
|
0.1 mmol/L
Standard Deviation 0.5
|
-0.0 mmol/L
Standard Deviation 0.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Blinded Phase: Baseline; Week 52/EOSPopulation: 133 participants in the BHR-700 arm and 65 in the placebo arm were included at baseline. Data from 97 BHR-700 and 48 placebo participants are reported at Week 52/EOS.
Bone biomarker levels (BSAP) at baseline will be compared to levels measured at Week 52.
Outcome measures
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=97 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
n=48 Participants
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Change in Serum Concentration of Select Bone Biomarkers: Bone Specific Alkaline Phosphatase (BSAP) (U/L)
|
1.0 BSAP in U/L
Standard Deviation 4.1
|
0.7 BSAP in U/L
Standard Deviation 3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Blinded Phase: Weeks 13, 26, 52/EOSPopulation: Concentrations measured only in participants who received BHR-700. Of all subjects that attended the Week 52/End of Study visit, only 24 subjects completed 52 weeks of treatment. All other subjects stopped treatment at various timepoints before the 52 weeks.
Blood samples will be taken to measure plasma concentrations of 4-OHT at time-points in the study
Outcome measures
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=179 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 13 E-4-OHT · Participants with measurable concentration
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 13 E-4-OHT · Participants with concentration below lower limit of quantitation
|
128 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 26 E-4-OHT · Participants with measurable concentration
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 26 E-4-OHT · Participants with concentration below lower limit of quantitation
|
88 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 52/EOS E-4-OHT · Participants with measurable concentration
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 52/EOS E-4-OHT · Participants with concentration below lower limit of quantitation
|
179 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 13 Z-4-OHT · Participants with measurable concentration
|
75 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 13 Z-4-OHT · Participants with concentration below lower limit of quantitation
|
65 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 26 Z-4-OHT · Participants with measurable concentration
|
48 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 26 Z-4-OHT · Participants with concentration below lower limit of quantitation
|
47 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 52/EOS Z-4-OHT · Participants with measurable concentration
|
16 Participants
|
—
|
—
|
—
|
|
Number of Participants With Measurable Plasma Concentrations of the E and Z Isomers of 4-OHT by Visit
Week 52/EOS Z-4-OHT · Participants with concentration below lower limit of quantitation
|
163 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blinded Phase: Baseline; Week 52/EOSPopulation: 133 participants in the BHR-700 arm and 65 in the placebo arm were included at baseline. Data from 97 BHR-700 and 48 placebo participants are reported at Week 52/EOS.
Bone biomarker levels (CTx) at baseline will be compared to levels measured at Week 52.
Outcome measures
| Measure |
BHR-700 (0.2% 4-OHT Gel)
n=97 Participants
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel
n=48 Participants
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Change in Serum Concentration of Select Bone Biomarkers:Type I Collagen C-Telopeptides (CTx) (pg/mL)
|
-19.6 pg/mL
Standard Deviation 162
|
3.7 pg/mL
Standard Deviation 155.5
|
—
|
—
|
Adverse Events
BHR-700 (0.2% 4-OHT Gel) in Blinded Phase
Serious events: 5 serious events
Other events: 71 other events
Deaths: 0 deaths
Matching Placebo Gel in Blinded Phase
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BHR-700 (0.2% 4-OHT Gel) in Blinded Phase
n=149 participants at risk
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel in Blinded Phase
n=73 participants at risk
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
n=7 participants at risk
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
n=6 participants at risk
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
Other adverse events
| Measure |
BHR-700 (0.2% 4-OHT Gel) in Blinded Phase
n=149 participants at risk
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Matching Placebo Gel in Blinded Phase
n=73 participants at risk
An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
Placebo: An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following BHR-700 in Blinded Phase
n=7 participants at risk
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
Open Label BHR-700 (0.2% 4-OHT Gel) Following Placebo in Blinded Phase
n=6 participants at risk
The gel formulation contains 2 mg/mL 4-OH tamoxifen (0.2%) in a clear, colorless, absorptive hydro-alcoholic gel base formulated to provide continuous release of 4-OH tamoxifen. A total of 8 mg/day (4 mg/breast) of 4-OH tamoxifen will be administered daily for 52 weeks.
4-OH tamoxifen: 4-Hydroxytamoxifen (afimoxifene) gel
|
|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
12/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
6.8%
5/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
6.0%
9/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
4.1%
3/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
8/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
11.0%
8/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
6/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
4.1%
3/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.4%
5/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
2.7%
4/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Bacterial vaginosis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Ear infection
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Heliobacter infection
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Laryngitis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Lip infection
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Mastitis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Otitis externa
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Tooth infection
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
6/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
5/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Peripheral arthritis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast pain
|
2.7%
4/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
2.7%
4/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast tenderness
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
4.1%
3/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast discoloration
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast mass
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Nipple disorder
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal erosion
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
7/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
4.1%
3/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
5/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
4.1%
3/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Lip swelling
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestinal polyp
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
10/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
11.0%
8/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.7%
7/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
9.6%
7/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
5.5%
4/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
8/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
5.5%
4/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
4/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
4.0%
6/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Pain
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Application site reaction
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Axillary pain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Feeling hot
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Inflammation
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Injection site pruritus
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Injection site swelling
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
General disorders
Medical device site ulcer
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
4.7%
7/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Migraine
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Tension headache
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.4%
5/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Body temperature increased
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Blood triglycerides increased
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Platelet count increased
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
QRS axis abnormal
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Rheumatoid factor increased
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Weight increased
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Mammogram abnormal
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Protein S decreased
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lobular breast carcinoma in situ
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval neoplasm
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Vascular disorders
Hot flush
|
2.7%
4/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
4.1%
3/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Vascular disorders
Peripheral venous disease
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Vascular disorders
Varicose vein
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
2.0%
3/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Psychiatric disorders
Libido increased
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Psychiatric disorders
Mood swings
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urine abnormality
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Dry eye
|
1.3%
2/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Cataract
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Eye haemorrhage
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Eye irritation
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Eyelid oedema
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Ear pruritis
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
2.7%
2/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Product Issues
Product odour abnormal
|
0.67%
1/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
1.4%
1/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of the liver
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
16.7%
1/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cyst
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
16.7%
1/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
16.7%
1/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Congenital, familial and genetic disorders
Dolichocolon
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
33.3%
2/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
16.7%
1/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/149 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/73 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
14.3%
1/7 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
0.00%
0/6 • Blinded and Open Label Portions of the Study up to 104 Weeks
The Safety Population is the population of all patients who receive at least 1 dose of study treatment.
|
Additional Information
Global Chief Medical Officer
Besins Healthcare Ireland Ltd
Phone: +353 87 1039215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place