Trial Outcomes & Findings for Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (NCT NCT03194646)
NCT ID: NCT03194646
Last Updated: 2025-07-28
Results Overview
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1272 participants
Primary outcome timeframe
From baseline to about 1 year after start of treatment
Results posted on
2025-07-28
Participant Flow
The study was conducted at 219 study centers in 13 countries worldwide between 30-Jun-2017 (first participant first visit) and 11-Jul-2024 (last participant last visit).
Overall, 2368 participants were screened. Of the 2368 screened participants, 1096 (46.3%) participants were not randomized to treatment due to screen failures. 1272 (53.7%) participants were randomized and 1238 (52.3%) participants received study treatment.
Participant milestones
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
363
|
361
|
183
|
365
|
|
Overall Study
Treated
|
349
|
347
|
177
|
365
|
|
Overall Study
COMPLETED
|
59
|
93
|
44
|
85
|
|
Overall Study
NOT COMPLETED
|
304
|
268
|
139
|
280
|
Reasons for withdrawal
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
24
|
25
|
14
|
17
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
2
|
12
|
|
Overall Study
Lost to Follow-up
|
30
|
22
|
12
|
35
|
|
Overall Study
Non-compliance with study drug
|
4
|
0
|
1
|
1
|
|
Overall Study
Other
|
89
|
68
|
34
|
31
|
|
Overall Study
Physician Decision
|
7
|
9
|
5
|
4
|
|
Overall Study
Pregnancy
|
4
|
5
|
1
|
2
|
|
Overall Study
Protocol Violation
|
4
|
2
|
1
|
1
|
|
Overall Study
Site terminated by sponsor
|
0
|
0
|
2
|
0
|
|
Overall Study
Study terminated by sponsor
|
62
|
61
|
30
|
34
|
|
Overall Study
Withdrawal by Subject
|
75
|
74
|
36
|
131
|
|
Overall Study
Missing
|
1
|
0
|
1
|
12
|
Baseline Characteristics
Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
Baseline characteristics by cohort
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
n=361 Participants
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
n=357 Participants
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
n=181 Participants
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
n=365 Participants
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
Total
n=1264 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.7 Years
STANDARD_DEVIATION 5.9 • n=361 Participants
|
41.6 Years
STANDARD_DEVIATION 6.0 • n=357 Participants
|
41.9 Years
STANDARD_DEVIATION 6.0 • n=181 Participants
|
42.2 Years
STANDARD_DEVIATION 6.1 • n=365 Participants
|
41.9 Years
STANDARD_DEVIATION 6.0 • n=1264 Participants
|
|
Sex: Female, Male
Female
|
361 Participants
n=361 Participants
|
357 Participants
n=357 Participants
|
181 Participants
n=181 Participants
|
365 Participants
n=365 Participants
|
1264 Participants
n=1264 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=361 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=181 Participants
|
0 Participants
n=365 Participants
|
0 Participants
n=1264 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=361 Participants
|
36 Participants
n=357 Participants
|
15 Participants
n=181 Participants
|
35 Participants
n=365 Participants
|
114 Participants
n=1264 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
330 Participants
n=361 Participants
|
319 Participants
n=357 Participants
|
166 Participants
n=181 Participants
|
327 Participants
n=365 Participants
|
1142 Participants
n=1264 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=361 Participants
|
2 Participants
n=357 Participants
|
0 Participants
n=181 Participants
|
3 Participants
n=365 Participants
|
8 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=361 Participants
|
6 Participants
n=357 Participants
|
2 Participants
n=181 Participants
|
3 Participants
n=365 Participants
|
17 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
Asian
|
124 Participants
n=361 Participants
|
126 Participants
n=357 Participants
|
64 Participants
n=181 Participants
|
129 Participants
n=365 Participants
|
443 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=361 Participants
|
0 Participants
n=357 Participants
|
0 Participants
n=181 Participants
|
0 Participants
n=365 Participants
|
0 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
Black or African American
|
99 Participants
n=361 Participants
|
90 Participants
n=357 Participants
|
43 Participants
n=181 Participants
|
100 Participants
n=365 Participants
|
332 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=361 Participants
|
129 Participants
n=357 Participants
|
71 Participants
n=181 Participants
|
132 Participants
n=365 Participants
|
461 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=361 Participants
|
3 Participants
n=357 Participants
|
0 Participants
n=181 Participants
|
0 Participants
n=365 Participants
|
6 Participants
n=1264 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=361 Participants
|
3 Participants
n=357 Participants
|
1 Participants
n=181 Participants
|
1 Participants
n=365 Participants
|
5 Participants
n=1264 Participants
|
|
Baseline bone mineral density (BMD) of lumbar spine, hip and femoral neck
Lumbar spine
|
1.1468 g/cm^2
STANDARD_DEVIATION 0.1869 • n=339 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.1653 g/cm^2
STANDARD_DEVIATION 0.1889 • n=338 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.1560 g/cm^2
STANDARD_DEVIATION 0.1807 • n=174 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.1532 g/cm^2
STANDARD_DEVIATION 0.1851 • n=350 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.1552 g/cm^2
STANDARD_DEVIATION 0.1860 • n=1201 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
|
Baseline bone mineral density (BMD) of lumbar spine, hip and femoral neck
Hip
|
0.9998 g/cm^2
STANDARD_DEVIATION 0.1528 • n=340 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.0044 g/cm^2
STANDARD_DEVIATION 0.1614 • n=337 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.0063 g/cm^2
STANDARD_DEVIATION 0.1508 • n=174 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
0.9944 g/cm^2
STANDARD_DEVIATION 0.1486 • n=357 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
1.0004 g/cm^2
STANDARD_DEVIATION 0.1536 • n=1208 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
|
Baseline bone mineral density (BMD) of lumbar spine, hip and femoral neck
Femoral neck
|
0.9050 g/cm^2
STANDARD_DEVIATION 0.1700 • n=340 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
0.9174 g/cm^2
STANDARD_DEVIATION 0.1808 • n=337 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
0.9150 g/cm^2
STANDARD_DEVIATION 0.1730 • n=174 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
0.9021 g/cm^2
STANDARD_DEVIATION 0.1703 • n=357 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
0.9090 g/cm^2
STANDARD_DEVIATION 0.1735 • n=1208 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline was missing.
|
|
Endometrial thickness
|
8.3 Millimeters
STANDARD_DEVIATION 3.8 • n=348 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline were missing.
|
8.3 Millimeters
STANDARD_DEVIATION 4.0 • n=344 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline were missing.
|
8.6 Millimeters
STANDARD_DEVIATION 3.8 • n=176 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline were missing.
|
8.7 Millimeters
STANDARD_DEVIATION 4.3 • n=363 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline were missing.
|
8.5 Millimeters
STANDARD_DEVIATION 4.0 • n=1231 Participants • Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Some data in baseline were missing.
|
PRIMARY outcome
Timeframe: From baseline to about 1 year after start of treatmentPopulation: Safety analysis set (SAF) was analyzed. SAF: All participants randomized to vilaprisan treatment groups who took at least 1 dose of study drug and all participants randomized to group B (standard of care) treatment group were included in the SAF. Participants were analyzed as treated. Overall number of participants analyzed represents number of participants without missing data.
The percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.
Outcome measures
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
n=112 Participants
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
n=143 Participants
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
n=57 Participants
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
n=181 Participants
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Percentage Change in Bone Mineral Density (BMD) of Lumbar Spine
|
-1.56 Percentage change
Standard Deviation 2.72
|
-2.04 Percentage change
Standard Deviation 2.50
|
-1.51 Percentage change
Standard Deviation 2.28
|
0.29 Percentage change
Standard Deviation 2.36
|
SECONDARY outcome
Timeframe: Treatment phase: approximately 1 yearPopulation: FAS was analyzed.
Number of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 days
Outcome measures
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
n=349 Participants
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
n=347 Participants
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
n=177 Participants
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
n=365 Participants
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Number of Bleeding Days
|
1.57 Days
Standard Deviation 1.99
|
1.74 Days
Standard Deviation 2.52
|
1.81 Days
Standard Deviation 1.24
|
4.72 Days
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Up to 3 years (from study treatment start to end of study)Population: SAF was analyzed.
Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancy
Outcome measures
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
n=349 Participants
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
n=347 Participants
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
n=177 Participants
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
n=365 Participants
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Benign Endometrium
|
346 Participants
|
346 Participants
|
175 Participants
|
359 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Hyperplasia WHO 2014, no atypia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Hyperplasia WHO 2014, atypia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Malignant Neoplasm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Endometrial Polyps
|
6 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Adequate endometrial tissue
|
346 Participants
|
346 Participants
|
175 Participants
|
359 Participants
|
SECONDARY outcome
Timeframe: Treatment phase: approximately 1 year, follow-up phase: up to 2 yearsPopulation: SAF was analyzed.
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.
Outcome measures
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
n=349 Participants
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
n=347 Participants
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
n=177 Participants
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
n=365 Participants
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Change From Baseline in Endometrial Thickness
Baseline
|
10.4 Millimeters
Standard Deviation 4.0
|
10.7 Millimeters
Standard Deviation 4.0
|
10.9 Millimeters
Standard Deviation 4.0
|
11.0 Millimeters
Standard Deviation 4.4
|
|
Change From Baseline in Endometrial Thickness
Treatment phase (change from baseline)
|
-0.5 Millimeters
Standard Deviation 5.6
|
-0.2 Millimeters
Standard Deviation 5.7
|
-0.9 Millimeters
Standard Deviation 4.7
|
-0.4 Millimeters
Standard Deviation 4.5
|
|
Change From Baseline in Endometrial Thickness
Follow up phase (change from baseline)
|
-0.2 Millimeters
Standard Deviation 5.2
|
-0.3 Millimeters
Standard Deviation 5.7
|
-1.1 Millimeters
Standard Deviation 4.5
|
-2.7 Millimeters
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Treatment phase: approximately 1 year, follow-up phase: up to 2 yearsPopulation: SAF was analyzed. Percentage change from baseline in BMD of lumbar spine, hip and femoral neck was presented by time interval in below table.
Percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.
Outcome measures
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen)
n=349 Participants
4 treatment periods of 12 weeks, each separated by 1 bleeding episode
|
Vilaprisan 2 mg A2 (6/2 Regimen)
n=347 Participants
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen)
n=177 Participants
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
B (Standard of Care)
n=365 Participants
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Lumbar spine - End of follow up
|
-0.64 Percentage change
Standard Deviation 4.23
|
-0.28 Percentage change
Standard Deviation 4.11
|
-0.38 Percentage change
Standard Deviation 4.26
|
-0.07 Percentage change
Standard Deviation 3.49
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Hip - Month 6 on treatment
|
-1.00 Percentage change
Standard Deviation 2.89
|
-0.48 Percentage change
Standard Deviation 2.49
|
1.54 Percentage change
Standard Deviation 1.21
|
-0.23 Percentage change
Standard Deviation 1.81
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Hip - Month 12 on treatment
|
-0.84 Percentage change
Standard Deviation 2.19
|
-0.99 Percentage change
Standard Deviation 2.23
|
-0.91 Percentage change
Standard Deviation 2.68
|
-0.03 Percentage change
Standard Deviation 2.47
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Hip - End of treatment
|
-0.85 Percentage change
Standard Deviation 2.28
|
-0.91 Percentage change
Standard Deviation 2.34
|
-0.61 Percentage change
Standard Deviation 2.63
|
-0.06 Percentage change
Standard Deviation 2.65
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Hip - Month 6 post treatment
|
-0.45 Percentage change
Standard Deviation 2.30
|
-0.62 Percentage change
Standard Deviation 2.60
|
-0.54 Percentage change
Standard Deviation 3.06
|
0.20 Percentage change
Standard Deviation 2.72
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Hip - Month 12 post treatment
|
-0.72 Percentage change
Standard Deviation 1.95
|
-0.33 Percentage change
Standard Deviation 1.91
|
1.41 Percentage change
Standard Deviation 2.22
|
-0.23 Percentage change
Standard Deviation 3.77
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Hip - End of follow up
|
-0.80 Percentage change
Standard Deviation 3.06
|
-0.03 Percentage change
Standard Deviation 3.85
|
-0.20 Percentage change
Standard Deviation 3.81
|
0.08 Percentage change
Standard Deviation 2.91
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Femoral neck - Month 6 on treatment
|
-0.71 Percentage change
Standard Deviation 2.69
|
0.66 Percentage change
Standard Deviation 3.27
|
1.23 Percentage change
Standard Deviation 3.08
|
0.08 Percentage change
Standard Deviation 3.80
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Femoral neck - Month 12 on treatment
|
-0.84 Percentage change
Standard Deviation 3.42
|
-0.64 Percentage change
Standard Deviation 3.45
|
-0.66 Percentage change
Standard Deviation 3.07
|
-0.01 Percentage change
Standard Deviation 3.42
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Femoral neck - Month 12 post treatment
|
-0.82 Percentage change
Standard Deviation 3.83
|
-1.27 Percentage change
Standard Deviation 3.60
|
-0.65 Percentage change
Standard Deviation 1.06
|
1.40 Percentage change
Standard Deviation 5.19
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Femoral neck - End of treatment
|
-1.12 Percentage change
Standard Deviation 3.37
|
-0.36 Percentage change
Standard Deviation 3.46
|
-0.42 Percentage change
Standard Deviation 3.21
|
-0.02 Percentage change
Standard Deviation 3.47
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Femoral neck - Month 6 post treatment
|
-0.87 Percentage change
Standard Deviation 3.45
|
-0.49 Percentage change
Standard Deviation 3.52
|
-0.35 Percentage change
Standard Deviation 3.80
|
-0.42 Percentage change
Standard Deviation 3.32
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Lumbar spine - Month 6 on treatment
|
-0.18 Percentage change
Standard Deviation 1.70
|
-0.49 Percentage change
Standard Deviation 2.74
|
0.51 Percentage change
Standard Deviation 2.52
|
-0.88 Percentage change
Standard Deviation 2.60
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Lumbar spine - End of treatment
|
-1.48 Percentage change
Standard Deviation 2.68
|
-1.76 Percentage change
Standard Deviation 2.64
|
-1.22 Percentage change
Standard Deviation 2.36
|
0.13 Percentage change
Standard Deviation 2.38
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Lumbar spine - Month 6 post treatment
|
-0.69 Percentage change
Standard Deviation 3.30
|
-0.89 Percentage change
Standard Deviation 2.72
|
-0.57 Percentage change
Standard Deviation 2.36
|
-0.17 Percentage change
Standard Deviation 2.76
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Lumbar spine - Month 12 post treatment
|
-0.10 Percentage change
Standard Deviation 2.81
|
-0.45 Percentage change
Standard Deviation 3.61
|
0.86 Percentage change
Standard Deviation 2.73
|
1.03 Percentage change
Standard Deviation 6.79
|
|
Percentage Change From Baseline in BMD Measured at Lumbar Spine (Other Time Points Not Mentioned as Primary Safety Variable) and Hip/Femoral Neck
Femoral neck - End of follow up
|
-0.90 Percentage change
Standard Deviation 4.41
|
-0.09 Percentage change
Standard Deviation 5.16
|
-0.52 Percentage change
Standard Deviation 5.70
|
-0.34 Percentage change
Standard Deviation 3.73
|
Adverse Events
Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs
Serious events: 15 serious events
Other events: 136 other events
Deaths: 0 deaths
Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs
Serious events: 17 serious events
Other events: 152 other events
Deaths: 0 deaths
Vilaprisan 2 mg A3 (3/2 Regimen) - Treatment Emergent AEs
Serious events: 6 serious events
Other events: 56 other events
Deaths: 0 deaths
Standard of Care B - Treatment Emergent AEs
Serious events: 17 serious events
Other events: 90 other events
Deaths: 0 deaths
Vilaprisan 2 mg A1 (3/1 Regimen) - Post Treatment AEs
Serious events: 54 serious events
Other events: 75 other events
Deaths: 0 deaths
Vilaprisan 2 mg A2 (6/2 Regimen) - Post Treatment AEs
Serious events: 42 serious events
Other events: 67 other events
Deaths: 0 deaths
Vilaprisan 2 mg A3 (3/2 Regimen) - Post Treatment AEs
Serious events: 27 serious events
Other events: 44 other events
Deaths: 0 deaths
Standard of Care B - Post Treatment AEs
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs
n=349 participants at risk
4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
|
Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs
n=347 participants at risk
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen) - Treatment Emergent AEs
n=177 participants at risk
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
Standard of Care B - Treatment Emergent AEs
n=365 participants at risk
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
Vilaprisan 2 mg A1 (3/1 Regimen) - Post Treatment AEs
n=349 participants at risk
4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
|
Vilaprisan 2 mg A2 (6/2 Regimen) - Post Treatment AEs
n=347 participants at risk
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen) - Post Treatment AEs
n=177 participants at risk
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
Standard of Care B - Post Treatment AEs
n=365 participants at risk
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.55%
2/365 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Congenital, familial and genetic disorders
Venous angioma of brain
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Congenital, familial and genetic disorders
BRCA1 gene mutation
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Endocrine disorders
Primary hyperaldosteronism
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.1%
2/177 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Endocrine disorders
Thyroid mass
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
General disorders
Chest pain
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
General disorders
Pyrexia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Endometritis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Mastitis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Pneumonia
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Alanine aminotransferase increased
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Biopsy peritoneum
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Blood pressure increased
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Norepinephrine increased
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Scan adrenal gland abnormal
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.3%
8/349 • Number of events 8 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.1%
2/177 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.57%
2/349 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.82%
3/365 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.86%
3/347 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.8%
5/177 • Number of events 5 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mesenteric neoplasm
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine myoma expulsion
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.57%
2/349 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord abnormality
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Psychiatric disorders
Suicidal ideation
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Psychiatric disorders
Psychotic disorder
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Psychiatric disorders
Substance abuse
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.55%
2/365 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.4%
5/349 • Number of events 5 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Hysterectomy
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.55%
2/365 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
5.2%
18/349 • Number of events 18 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.6%
16/347 • Number of events 16 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.5%
8/177 • Number of events 8 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Myomectomy
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.55%
2/365 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.7%
6/349 • Number of events 6 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.4%
5/347 • Number of events 5 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.1%
2/177 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Salpingectomy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Salpingo-oophorectomy bilateral
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Simple mastectomy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Hysterosalpingo-oophorectomy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Endometrial ablation
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Cyst removal
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Intestinal adhesion lysis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Hysterosalpingectomy
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.86%
3/349 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Meniscus removal
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Uterine leiomyoma embolisation
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Degeneration of uterine leiomyoma
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.57%
2/349 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia with cellular atypia
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Uterine artery embolisation
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/349 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Surgical and medical procedures
Abdominal adhesiolysis
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/347 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/349 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.29%
1/347 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
Other adverse events
| Measure |
Vilaprisan 2 mg A1 (3/1 Regimen) - Treatment Emergent AEs
n=349 participants at risk
4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
|
Vilaprisan 2 mg A2 (6/2 Regimen) - Treatment Emergent AEs
n=347 participants at risk
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen) - Treatment Emergent AEs
n=177 participants at risk
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
Standard of Care B - Treatment Emergent AEs
n=365 participants at risk
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
Vilaprisan 2 mg A1 (3/1 Regimen) - Post Treatment AEs
n=349 participants at risk
4 treatment periods of 12 weeks, each separated by 1 bleeding episode (3/1 regimen)
|
Vilaprisan 2 mg A2 (6/2 Regimen) - Post Treatment AEs
n=347 participants at risk
2 treatment periods of 24 weeks, separated by 2 bleeding episodes
|
Vilaprisan 2 mg A3 (3/2 Regimen) - Post Treatment AEs
n=177 participants at risk
3 treatment periods of 12 weeks, each separated by 2 bleeding episodes
|
Standard of Care B - Post Treatment AEs
n=365 participants at risk
Standard of care symptomatic nonhormonal medical treatment as determined by the investigators and/or watch and wait
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
4/349 • Number of events 4 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.3%
8/347 • Number of events 8 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.7%
3/177 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
7.9%
29/365 • Number of events 30 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.9%
10/349 • Number of events 10 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
3.5%
12/347 • Number of events 12 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.5%
8/177 • Number of events 8 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
General disorders
Fatigue
|
3.7%
13/349 • Number of events 13 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
5.8%
20/347 • Number of events 20 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
3.4%
6/177 • Number of events 6 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.9%
18/365 • Number of events 20 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.57%
2/349 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.86%
3/347 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.7%
3/177 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.55%
2/365 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
37/349 • Number of events 51 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
12.1%
42/347 • Number of events 55 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
7.9%
14/177 • Number of events 15 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
3.3%
12/365 • Number of events 16 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.0%
14/349 • Number of events 22 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
3.5%
12/347 • Number of events 16 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.3%
4/177 • Number of events 4 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Investigations
Bone density decreased
|
0.29%
1/349 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/177 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
7.7%
27/349 • Number of events 27 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
7.2%
25/347 • Number of events 25 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
8.5%
15/177 • Number of events 15 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.6%
6/365 • Number of events 6 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Nervous system disorders
Headache
|
8.6%
30/349 • Number of events 43 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
6.9%
24/347 • Number of events 37 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
5.1%
9/177 • Number of events 9 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.9%
7/365 • Number of events 13 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.7%
6/349 • Number of events 6 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.58%
2/347 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.3%
4/177 • Number of events 4 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
4.6%
16/349 • Number of events 26 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
6.9%
24/347 • Number of events 45 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
5.1%
9/177 • Number of events 15 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.6%
6/365 • Number of events 8 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.6%
16/349 • Number of events 34 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.9%
10/347 • Number of events 15 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.1%
2/177 • Number of events 2 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.82%
3/365 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Endometrial thickening
|
8.0%
28/349 • Number of events 34 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
11.2%
39/347 • Number of events 44 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
5.1%
9/177 • Number of events 9 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
3.6%
13/365 • Number of events 16 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.57%
2/349 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.2%
4/347 • Number of events 4 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.0%
7/177 • Number of events 7 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
3.4%
12/349 • Number of events 13 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
2.9%
10/347 • Number of events 10 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.7%
3/177 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
7.4%
27/365 • Number of events 30 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.6%
16/349 • Number of events 21 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.7%
6/347 • Number of events 8 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
4.5%
8/177 • Number of events 9 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.27%
1/365 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
|
Vascular disorders
Hot flush
|
11.5%
40/349 • Number of events 53 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
12.7%
44/347 • Number of events 51 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
11.3%
20/177 • Number of events 24 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.86%
3/349 • Number of events 3 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
1.4%
5/347 • Number of events 5 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.56%
1/177 • Number of events 1 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
0.00%
0/365 • Treatment emergent adverse events (TEAEs): From first application of study medication up to 60 calendar days after end of study medication intake (mean duration 321 days). Post-treatment AEs: All AEs that started from Day 61 after end of study medication intake (mean duration 314 days for all participants until premature termination of the study, and 1572 days for Turkish participants who continued follow-up up to 5 years after individual end of study medication intake unless they withdrew).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60