Trial Outcomes & Findings for Bay98-7196, Dose Finding / POC Study (NCT NCT02203331)
NCT ID: NCT02203331
Last Updated: 2023-11-07
Results Overview
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
319 participants
Primary outcome timeframe
Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)
Results posted on
2023-11-07
Participant Flow
Study was conducted in fourteen countries in Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Germany, Japan, Netherlands, Norway, Poland, Spain, Switzerland, United States, between 16 October 2014 (first participant first visit) and 24 October 2016 (last participant last visit).
Overall, 605 participants were screened, of them 286 failed screening, remaining 319 participants were randomized and allocated to treatment, of them 14 participants did not receive study treatment for various reasons, remaining 305 participants were treated and 272 participants completed study treatment.
Participant milestones
| Measure |
LNG 40 mcg IVR + Placebo Injection
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
55
|
53
|
53
|
53
|
|
Overall Study
Treated
|
49
|
50
|
54
|
49
|
50
|
53
|
|
Overall Study
COMPLETED
|
45
|
39
|
50
|
46
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
5
|
7
|
7
|
7
|
Reasons for withdrawal
| Measure |
LNG 40 mcg IVR + Placebo Injection
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
3
|
|
Overall Study
Adverse Event
|
4
|
8
|
3
|
4
|
3
|
3
|
|
Overall Study
Other Reasons
|
1
|
2
|
0
|
2
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Bay98-7196, Dose Finding / POC Study
Baseline characteristics by cohort
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=52 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=53 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=55 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=53 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=53 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=53 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Total
n=319 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.27 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
32.96 years
STANDARD_DEVIATION 8.79 • n=7 Participants
|
33.96 years
STANDARD_DEVIATION 5.73 • n=5 Participants
|
33.72 years
STANDARD_DEVIATION 7.85 • n=4 Participants
|
33.7 years
STANDARD_DEVIATION 6.29 • n=21 Participants
|
34.89 years
STANDARD_DEVIATION 7.13 • n=10 Participants
|
33.75 years
STANDARD_DEVIATION 7.23 • n=115 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
53 Participants
n=10 Participants
|
319 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Body Mass Index (BMI)
|
24.19 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.52 • n=5 Participants
|
26.07 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.71 • n=7 Participants
|
23.84 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 6.15 • n=5 Participants
|
25.47 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.68 • n=4 Participants
|
25.47 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.51 • n=21 Participants
|
24.43 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.08 • n=10 Participants
|
24.91 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.67 • n=115 Participants
|
|
Mean Pain of the 7 Days With Worst Endometriosis Associated Pelvic Pain (EAPP)
|
7.8205 units on a scale
STANDARD_DEVIATION 1.171 • n=5 Participants
|
7.4664 units on a scale
STANDARD_DEVIATION 0.9893 • n=7 Participants
|
8.1905 units on a scale
STANDARD_DEVIATION 1.068 • n=5 Participants
|
7.5429 units on a scale
STANDARD_DEVIATION 1.2568 • n=4 Participants
|
7.8964 units on a scale
STANDARD_DEVIATION 1.1952 • n=21 Participants
|
7.6886 units on a scale
STANDARD_DEVIATION 1.2389 • n=10 Participants
|
7.7842 units on a scale
STANDARD_DEVIATION 1.1702 • n=115 Participants
|
|
Percentage of Days With Pain Greater Than or Equal to (>=) 7
|
50.094 percentage of days
STANDARD_DEVIATION 35.5201 • n=5 Participants
|
40.1521 percentage of days
STANDARD_DEVIATION 29.8714 • n=7 Participants
|
55.1155 percentage of days
STANDARD_DEVIATION 33.7625 • n=5 Participants
|
37.3044 percentage of days
STANDARD_DEVIATION 30.2894 • n=4 Participants
|
48.7001 percentage of days
STANDARD_DEVIATION 33.6685 • n=21 Participants
|
41.1847 percentage of days
STANDARD_DEVIATION 33.0479 • n=10 Participants
|
45.8234 percentage of days
STANDARD_DEVIATION 33.1247 • n=115 Participants
|
|
Percentage of Days With Pain >=4
|
86.0058 percentage of days
STANDARD_DEVIATION 19.3136 • n=5 Participants
|
84.7239 percentage of days
STANDARD_DEVIATION 18.1713 • n=7 Participants
|
89.029 percentage of days
STANDARD_DEVIATION 16.3667 • n=5 Participants
|
85.8451 percentage of days
STANDARD_DEVIATION 17.9466 • n=4 Participants
|
92.9141 percentage of days
STANDARD_DEVIATION 11.6008 • n=21 Participants
|
80.4397 percentage of days
STANDARD_DEVIATION 20.1004 • n=10 Participants
|
86.6042 percentage of days
STANDARD_DEVIATION 17.6568 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)Population: The dose-response analysis was performed using the MCP-Mod method with groups containing LNG, ATZ + LNG, and Placebo. It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=39 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=33 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=40 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD
|
-1.8974 units on a scale
Standard Deviation 1.6416 • Interval 1.6416 to
|
-1.6061 units on a scale
Standard Deviation 1.6652 • Interval 1.6652 to
|
-2.4014 units on a scale
Standard Deviation 2.1833 • Interval 2.1833 to
|
-2.2653 units on a scale
Standard Deviation 1.5972 • Interval 1.5972 to
|
-3.7679 units on a scale
Standard Deviation 2.3507 • Interval 1.8247 to
|
-2.293 units on a scale
Standard Deviation 1.8247
|
SECONDARY outcome
Timeframe: Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)Population: It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=39 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=34 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=40 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD
Change at Treatment 1
|
-0.7582 units on a scale
Standard Deviation 1.1518 • Interval 1.1518 to
|
-0.6849 units on a scale
Standard Deviation 1.3832 • Interval 1.3832 to
|
-1.1463 units on a scale
Standard Deviation 1.3992 • Interval 1.3992 to
|
-1.0000 units on a scale
Standard Deviation 1.2579 • Interval 1.2579 to
|
-1.2071 units on a scale
Standard Deviation 1.1978 • Interval 1.1978 to
|
-0.9048 units on a scale
Standard Deviation 1.1686 • Interval 1.1686 to
|
|
Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD
Change at Treatment 2
|
-1.6447 units on a scale
Standard Deviation 1.4831 • Interval 1.4831 to
|
-1.5126 units on a scale
Standard Deviation 2.0161 • Interval 2.0161 to
|
-2.1224 units on a scale
Standard Deviation 2.2791 • Interval 2.2791 to
|
-1.9959 units on a scale
Standard Deviation 1.3978 • Interval 1.3978 to
|
-2.8607 units on a scale
Standard Deviation 2.0665 • Interval 2.0665 to
|
-1.8022 units on a scale
Standard Deviation 1.5131 • Interval 1.5131 to
|
SECONDARY outcome
Timeframe: Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)Population: It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=39 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=34 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=40 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
Change at Treatment 2
|
-1.5774 units on a scale
Standard Deviation 1.6278
|
-1.5068 units on a scale
Standard Deviation 1.8707
|
-1.7349 units on a scale
Standard Deviation 1.9403
|
-1.9615 units on a scale
Standard Deviation 1.3966
|
-2.6855 units on a scale
Standard Deviation 2.0601
|
-1.8994 units on a scale
Standard Deviation 1.3069
|
|
Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
Change at Treatment 1
|
-0.8472 units on a scale
Standard Deviation 1.1905
|
-0.9009 units on a scale
Standard Deviation 1.3434
|
-1.0931 units on a scale
Standard Deviation 1.4002
|
-1.1257 units on a scale
Standard Deviation 1.3317
|
-1.5315 units on a scale
Standard Deviation 1.4809
|
-0.9777 units on a scale
Standard Deviation 1.0680
|
|
Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
Baseline
|
6.0938 units on a scale
Standard Deviation 1.5314
|
5.7409 units on a scale
Standard Deviation 1.3044
|
6.3694 units on a scale
Standard Deviation 1.5300
|
5.7128 units on a scale
Standard Deviation 1.4415
|
6.3962 units on a scale
Standard Deviation 1.4575
|
5.6399 units on a scale
Standard Deviation 1.5312
|
|
Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD
Change at Treatment 3
|
-1.8001 units on a scale
Standard Deviation 1.7687
|
-1.6411 units on a scale
Standard Deviation 1.8071
|
-2.0112 units on a scale
Standard Deviation 1.9575
|
-2.1268 units on a scale
Standard Deviation 1.6877
|
-3.502 units on a scale
Standard Deviation 2.3096
|
-2.2228 units on a scale
Standard Deviation 1.4957
|
SECONDARY outcome
Timeframe: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)Population: It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain \>=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was \>=7.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=41 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=34 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=41 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
Treatment 1
|
35.6034 percentage of days
Standard Deviation 34.3126
|
27.5659 percentage of days
Standard Deviation 27.6426
|
40.0813 percentage of days
Standard Deviation 37.2694
|
23.9322 percentage of days
Standard Deviation 28.6234
|
28.2015 percentage of days
Standard Deviation 28.8430
|
25.1742 percentage of days
Standard Deviation 24.2811
|
|
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
Treatment 2
|
25.6257 percentage of days
Standard Deviation 33.9315
|
22.8695 percentage of days
Standard Deviation 28.3443
|
34.4364 percentage of days
Standard Deviation 40.5623
|
14.9331 percentage of days
Standard Deviation 23.8028
|
12.1320 percentage of days
Standard Deviation 25.1638
|
14.1869 percentage of days
Standard Deviation 17.7364
|
|
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD
Treatment 3
|
23.1293 percentage of days
Standard Deviation 33.9451
|
19.9332 percentage of days
Standard Deviation 26.0540
|
29.8103 percentage of days
Standard Deviation 39.0434
|
14.3362 percentage of days
Standard Deviation 25.6770
|
8.5351 percentage of days
Standard Deviation 20.7819
|
12.7574 percentage of days
Standard Deviation 18.5154
|
SECONDARY outcome
Timeframe: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)Population: It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain \>=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was \>=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=39 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=34 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=40 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
Change at Treatment 1
|
-13.6756 percentage of days
Standard Deviation 22.6822
|
-12.5862 percentage of days
Standard Deviation 21.4336
|
-15.0341 percentage of days
Standard Deviation 21.0071
|
-13.3722 percentage of days
Standard Deviation 19.6416
|
-19.8898 percentage of days
Standard Deviation 25.9273
|
-16.0105 percentage of days
Standard Deviation 19.0190
|
|
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
Change at Treatment 2
|
-24.1404 percentage of days
Standard Deviation 28.5082
|
-17.2826 percentage of days
Standard Deviation 29.0007
|
-20.6791 percentage of days
Standard Deviation 30.2152
|
-22.3713 percentage of days
Standard Deviation 24.4098
|
-36.3540 percentage of days
Standard Deviation 34.9706
|
-26.9979 percentage of days
Standard Deviation 24.9493
|
|
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD
Change at Treatment 3
|
-26.4197 percentage of days
Standard Deviation 31.4648
|
-20.8529 percentage of days
Standard Deviation 28.3939
|
-25.3052 percentage of days
Standard Deviation 33.5497
|
-22.9682 percentage of days
Standard Deviation 28.8677
|
-39.9516 percentage of days
Standard Deviation 33.8277
|
-28.4273 percentage of days
Standard Deviation 29.6186
|
SECONDARY outcome
Timeframe: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)Population: It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain \>=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was \>=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=41 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=34 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=41 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
Treatment 1
|
71.8037 percentage of days
Standard Deviation 32.3658
|
69.3092 percentage of days
Standard Deviation 27.8642
|
73.8956 percentage of days
Standard Deviation 31.6868
|
70.6504 percentage of days
Standard Deviation 27.8528
|
70.2066 percentage of days
Standard Deviation 28.9333
|
65.9074 percentage of days
Standard Deviation 30.0166
|
|
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
Treatment 2
|
61.8199 percentage of days
Standard Deviation 37.1217
|
57.8777 percentage of days
Standard Deviation 34.7429
|
62.5822 percentage of days
Standard Deviation 37.6989
|
52.6028 percentage of days
Standard Deviation 35.6106
|
54.0965 percentage of days
Standard Deviation 38.9629
|
49.487 percentage of days
Standard Deviation 31.3566
|
|
Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD
Treatment 3
|
60.2902 percentage of days
Standard Deviation 37.8585
|
57.0171 percentage of days
Standard Deviation 34.3642
|
56.7691 percentage of days
Standard Deviation 40.3803
|
50.7332 percentage of days
Standard Deviation 36.2903
|
38.6986 percentage of days
Standard Deviation 39.6045
|
47.0976 percentage of days
Standard Deviation 35.3227
|
SECONDARY outcome
Timeframe: Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)Population: It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.
Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain \>=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was \>=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.
Outcome measures
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=39 Participants
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=34 Participants
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=42 Participants
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=35 Participants
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=40 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=39 Participants
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
Change at Treatment 1
|
-12.8228 percentage of days
Standard Deviation 20.4330
|
-15.4147 percentage of days
Standard Deviation 24.0608
|
-15.1334 percentage of days
Standard Deviation 22.5347
|
-15.1947 percentage of days
Standard Deviation 21.1740
|
-21.4331 percentage of days
Standard Deviation 23.4546
|
-14.5323 percentage of days
Standard Deviation 20.9670
|
|
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
Change at Treatment 2
|
-22.4950 percentage of days
Standard Deviation 28.1535
|
-26.8462 percentage of days
Standard Deviation 32.6194
|
-26.4468 percentage of days
Standard Deviation 34.4661
|
-33.2423 percentage of days
Standard Deviation 27.3686
|
-37.7330 percentage of days
Standard Deviation 36.9484
|
-30.9527 percentage of days
Standard Deviation 25.4665
|
|
Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD
Change at Treatment 3
|
-23.5498 percentage of days
Standard Deviation 30.2853
|
-27.4770 percentage of days
Standard Deviation 34.2051
|
-32.2600 percentage of days
Standard Deviation 37.4997
|
-35.1119 percentage of days
Standard Deviation 30.9316
|
-53.4266 percentage of days
Standard Deviation 38.8452
|
-33.3421 percentage of days
Standard Deviation 25.7105
|
Adverse Events
LNG 40 mcg IVR + Placebo Injection
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo IVR + Leuprorelin Injection
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo IVR + Placebo Injection
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=49 participants at risk
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=50 participants at risk
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=54 participants at risk
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=49 participants at risk
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=50 participants at risk
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=53 participants at risk
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy of unknown location
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Endometriosis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
Other adverse events
| Measure |
LNG 40 mcg IVR + Placebo Injection
n=49 participants at risk
Participants wore an intra-vaginal ring (IVR) of Levonorgestrel (LNG) 40 microgram (mcg) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin intramuscular (i.m.) injection (3 month depot) on the first day of study treatment.
|
ATZ 300 mcg / LNG 40 mcg IVR + Placebo Injection
n=50 participants at risk
Participants wore IVR of Anastrozole (ATZ) 300 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 600 mcg / LNG 40 mcg IVR + Placebo Injection
n=54 participants at risk
Participants wore IVR of ATZ 600 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
ATZ 1050 mcg / LNG 40 mcg IVR + Placebo Injection
n=49 participants at risk
Participants wore IVR of ATZ 1050 mcg and LNG 40 mcg (BAY98-7196) continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Leuprorelin Injection
n=50 participants at risk
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of 11.25 milligram (mg) leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
Placebo IVR + Placebo Injection
n=53 participants at risk
Participants wore IVR of placebo matched to BAY98-7196 continuously for 84 days, with exchange of the IVR every 28 days and participants were administered a single dose of placebo matched to leuprorelin i.m. injection (3 month depot) on the first day of study treatment.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Ear and labyrinth disorders
Deafness transitory
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Eye disorders
Conjunctivitis allergic
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Eye disorders
Eyelid rash
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
8.2%
4/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.0%
3/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.1%
3/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
7.5%
4/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
8.2%
4/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.0%
3/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.7%
3/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Noninfectious peritonitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Gastrointestinal disorders
Faeces soft
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Asthenia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Chest pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Face oedema
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Fatigue
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.0%
3/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Feeling hot
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Hunger
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Injection site reaction
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Malaise
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Oedema
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Oedema peripheral
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Pelvic mass
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Pyrexia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Swelling
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Peripheral swelling
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Medical device discomfort
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
General disorders
Medical device site discomfort
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Bacterial vaginosis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Bronchitis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Cystitis
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Ear infection
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Influenza
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.0%
3/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Nasopharyngitis
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
13.0%
7/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
10.2%
5/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.7%
3/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Periodontitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Pulpitis dental
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Sinusitis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.6%
3/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Urethritis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Nail infection
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Injury, poisoning and procedural complications
Closed globe injury
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Blood triglycerides increased
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Colonoscopy
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Blood urine present
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Red blood cells urine positive
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Weight decreased
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Weight increased
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
White blood cells urine positive
|
6.1%
3/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Urine bilirubin increased
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Nitrite urine present
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Protein urine present
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Urine ketone body present
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Smear vaginal abnormal
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Investigations
Gardnerella test positive
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.7%
3/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Headache
|
10.2%
5/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
16.0%
8/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.6%
3/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
16.3%
8/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
16.0%
8/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
11.3%
6/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Migraine
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Neuralgia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
8.0%
4/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Mood swings
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Breast cyst
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Breast pain
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Dyspareunia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.0%
3/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Endometriosis
|
6.1%
3/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.6%
3/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
9.4%
5/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Galactorrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Metrorrhagia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
40.8%
20/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
40.0%
20/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
44.4%
24/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
32.7%
16/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
10.0%
5/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
13.2%
7/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Ovarian rupture
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.0%
3/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.7%
2/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
8.2%
4/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Varicose veins pelvic
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
8.0%
4/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.0%
2/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Uterine haematoma
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vaginal flatulence
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Reproductive system and breast disorders
Abnormal withdrawal bleeding
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.1%
2/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
10.2%
5/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Surgical and medical procedures
Wisdom teeth removal
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Vascular disorders
Flushing
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Vascular disorders
Haematoma
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Vascular disorders
Hot flush
|
2.0%
1/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
5.6%
3/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
6.1%
3/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
34.0%
17/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
3.8%
2/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Product Issues
Device breakage
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
1.9%
1/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
|
Product Issues
Device expulsion
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
2.0%
1/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/54 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/49 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/50 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
0.00%
0/53 • From start of study treatment up to 30 days after end of treatment (Day 114)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For a period of five (5) years from the date of last disclosure under this Agreement. Recipient shall (a) maintain all Confidential Information in confidence and not disclose the same to any third party unless required to do so by court order or by law, in which case Recipient shall notify Bayer in writing prior to making such a disclosure, and (b) not use any Confidential Information for its own benefit or for the benefit of any third party.
- Publication restrictions are in place
Restriction type: OTHER