Trial Outcomes & Findings for Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4) (NCT NCT03400956)
NCT ID: NCT03400956
Last Updated: 2022-06-30
Results Overview
Amenorrhea was defined as menstrual blood loss (MBL) \< 2 mL during the last 28 days of treatment. The evaluation of MBL was based on the Alkaline hematin (AH) method.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
The last 28 days of treatment period 1
Results posted on
2022-06-30
Participant Flow
The study was conducted at 87 study centers in USA, Japan, Czech Republic, Russia, and Ukraine between 24-Jan-2018 (first participant first visit) and 30-Jun-2021 (last participant last visit).
Overall, 481 participants were screened, of them, 378 (78.6%) participants were not randomized to treatment. The majority of these (n=286) were screen failures. Of the 103 participants who were randomized, 91 participants received study treatment. Full analysis set (FAS) consisted of all randomized subjects, excluding randomized subjects who did not start treatment period 1 (never received study drug) due to the study being closed prematurely (7 \[6.8%\]), and included 96 (93.2%) subjects.
Participant milestones
| Measure |
Vilaprisan (A1)
Vilaprisan in treatment period (TP) 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Treatment Period 1
STARTED
|
35
|
34
|
34
|
|
Treatment Period 1
Treated
|
31
|
30
|
30
|
|
Treatment Period 1
FAS
|
32
|
33
|
31
|
|
Treatment Period 1
COMPLETED
|
31
|
26
|
25
|
|
Treatment Period 1
NOT COMPLETED
|
4
|
8
|
9
|
|
Post-treatment Period 1
STARTED
|
31
|
26
|
25
|
|
Post-treatment Period 1
COMPLETED
|
9
|
10
|
9
|
|
Post-treatment Period 1
NOT COMPLETED
|
22
|
16
|
16
|
|
Treatment Period 2
STARTED
|
9
|
10
|
9
|
|
Treatment Period 2
COMPLETED
|
5
|
7
|
5
|
|
Treatment Period 2
NOT COMPLETED
|
4
|
3
|
4
|
|
Follow-up Period
STARTED
|
6
|
9
|
7
|
|
Follow-up Period
COMPLETED
|
6
|
9
|
5
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Vilaprisan (A1)
Vilaprisan in treatment period (TP) 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
1
|
0
|
|
Treatment Period 1
Lost to Follow-up
|
0
|
0
|
1
|
|
Treatment Period 1
Protocol Violation
|
0
|
2
|
0
|
|
Treatment Period 1
Study terminated by sponsor
|
3
|
1
|
1
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
2
|
4
|
|
Treatment Period 1
Other
|
1
|
2
|
3
|
|
Post-treatment Period 1
Adverse Event
|
0
|
0
|
1
|
|
Post-treatment Period 1
Physician Decision
|
2
|
3
|
0
|
|
Post-treatment Period 1
Study terminated by sponsor
|
11
|
10
|
11
|
|
Post-treatment Period 1
Withdrawal by Subject
|
5
|
0
|
0
|
|
Post-treatment Period 1
Other
|
4
|
3
|
4
|
|
Treatment Period 2
Adverse Event
|
2
|
1
|
1
|
|
Treatment Period 2
Lost to Follow-up
|
1
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
3
|
|
Treatment Period 2
Other
|
1
|
1
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
0
|
1
|
|
Follow-up Period
Other
|
0
|
0
|
1
|
Baseline Characteristics
Safety analysis set (SAF) was analyzed. The SAF consisted of all randomized participants who took at least 1 dose of study drug and included 91 (88.3%) participants.
Baseline characteristics by cohort
| Measure |
Vilaprisan (A1)
n=32 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=33 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 5.5 • n=32 Participants
|
42.7 Years
STANDARD_DEVIATION 6.0 • n=33 Participants
|
43.8 Years
STANDARD_DEVIATION 4.3 • n=31 Participants
|
43.2 Years
STANDARD_DEVIATION 5.3 • n=96 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=32 Participants
|
33 Participants
n=33 Participants
|
31 Participants
n=31 Participants
|
96 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
5 Participants
n=31 Participants
|
10 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=32 Participants
|
30 Participants
n=33 Participants
|
26 Participants
n=31 Participants
|
86 Participants
n=96 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=32 Participants
|
11 Participants
n=33 Participants
|
11 Participants
n=31 Participants
|
33 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=32 Participants
|
7 Participants
n=33 Participants
|
8 Participants
n=31 Participants
|
21 Participants
n=96 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=32 Participants
|
15 Participants
n=33 Participants
|
10 Participants
n=31 Participants
|
38 Participants
n=96 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=96 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=96 Participants
|
|
Endometrial thickness
|
12.8 Millimeters
STANDARD_DEVIATION 4.5 • n=31 Participants • Safety analysis set (SAF) was analyzed. The SAF consisted of all randomized participants who took at least 1 dose of study drug and included 91 (88.3%) participants.
|
12.8 Millimeters
STANDARD_DEVIATION 2.9 • n=30 Participants • Safety analysis set (SAF) was analyzed. The SAF consisted of all randomized participants who took at least 1 dose of study drug and included 91 (88.3%) participants.
|
11.9 Millimeters
STANDARD_DEVIATION 3.9 • n=30 Participants • Safety analysis set (SAF) was analyzed. The SAF consisted of all randomized participants who took at least 1 dose of study drug and included 91 (88.3%) participants.
|
12.5 Millimeters
STANDARD_DEVIATION 3.9 • n=91 Participants • Safety analysis set (SAF) was analyzed. The SAF consisted of all randomized participants who took at least 1 dose of study drug and included 91 (88.3%) participants.
|
PRIMARY outcome
Timeframe: The last 28 days of treatment period 1Population: FAS population with evaluable data.
Amenorrhea was defined as menstrual blood loss (MBL) \< 2 mL during the last 28 days of treatment. The evaluation of MBL was based on the Alkaline hematin (AH) method.
Outcome measures
| Measure |
Vilaprisan (A1)
n=32 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=33 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Number of Participants With Amenorrhea
|
29 Participants
|
1 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: The last 28 days of treatment period 1 and treatment period 2Population: FAS population with valuable data.
HMB was defined as MBL \<80.00 mL during the last 28 days of treatment and \>50% reduction compared to baseline (assessed by the AH method).
Outcome measures
| Measure |
Vilaprisan (A1)
n=32 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=33 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
Treatment period 1
|
30 Participants
|
7 Participants
|
26 Participants
|
|
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
Treatment period 2
|
6 Participants
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)Population: FAS population with valuable data. In treatment period 2, participants who did not start the respective treatment period or had less than 28 days of treatment are included among censored observations.
Onset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<2 mL (amenorrhea defined similar to primary endpoint and assessed by the AH method).
Outcome measures
| Measure |
Vilaprisan (A1)
n=32 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=33 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Time to Onset of Amenorrhea
Treatment period 1
|
3 Days
Interval 2.0 to 4.0
|
NA Days
NA: value could not be estimated due to censored data.
|
3 Days
Interval 1.0 to 9.0
|
|
Time to Onset of Amenorrhea
Treatment period 2
|
3 Days
Interval 2.0 to 20.0
|
4 Days
Interval 3.0 to
NA: value could not be estimated due to censored data.
|
NA Days
NA: value could not be estimated due to censored data.
|
SECONDARY outcome
Timeframe: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)Population: FAS population with valuable data. In treatment period 2, participants who did not start the respective treatment period or had less than 28 days of treatment are included among censored observations.
Onset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was \<80.00 mL (assessed by the AH method).
Outcome measures
| Measure |
Vilaprisan (A1)
n=32 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=33 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Time to Onset of Controlled Bleeding
Treatment period 1
|
1 Days
Interval 1.0 to 1.0
|
NA Days
NA: value could not be calculated because less than 50% of subjects in group showed response.
|
1 Days
Interval 1.0 to 2.0
|
|
Time to Onset of Controlled Bleeding
Treatment period 2
|
1.5 Days
Interval 1.0 to 1.9
|
1 Days
Interval 1.0 to 2.0
|
NA Days
NA: value could not be calculated because less than 50% of subjects in group showed response.
|
SECONDARY outcome
Timeframe: The last 28 days of treatment period 1 and treatment period 2Population: FAS population with valuable data.
Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects' daily responses to the UF-DBD (Uterine Fibroid Daily Bleeding Diary).
Outcome measures
| Measure |
Vilaprisan (A1)
n=32 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=33 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Number of Participants With Absence of Bleeding (Spotting Allowed)
Treatment period 2
|
6 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Absence of Bleeding (Spotting Allowed)
Treatment period 1
|
29 Participants
|
2 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Up to 36 weeksPopulation: Samples with sufficient tissue for analysis in SAF population was analyzed.
Number of participants with endometrial histology findings, e.g. benign endometrium, malignant neoplasm, hyperplasia without atypia, hyperplasia with atypia and endometrial polyps.
Outcome measures
| Measure |
Vilaprisan (A1)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=30 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=30 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Adequate endometrial tissue
|
31 Participants
|
30 Participants
|
26 Participants
|
|
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Benign Endometrium
|
31 Participants
|
30 Participants
|
26 Participants
|
|
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Hyperplasia WHO 2014, no atypia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Hyperplasia WHO 2014, atypia
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Malignant Neoplasm
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Endometrial Polyps
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)Population: SAF was analyzed. Overall number of participants analyzed represents number of participants without missing data.
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
Outcome measures
| Measure |
Vilaprisan (A1)
n=31 Participants
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Placebo+Vilaprisan (B1)
n=30 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=30 Participants
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
|---|---|---|---|
|
Change From Baseline of Endometrial Thickness
Treatment period 1
|
-2.5 Millimeters
Standard Deviation 4.1
|
-2.8 Millimeters
Standard Deviation 2.6
|
-3.1 Millimeters
Standard Deviation 3.7
|
|
Change From Baseline of Endometrial Thickness
Treatment period 2
|
-5.3 Millimeters
Standard Deviation 7.6
|
-3.5 Millimeters
Standard Deviation 4.1
|
-0.4 Millimeters
Standard Deviation 4.1
|
Adverse Events
Vilaprisan (A1) - Treatment Emergent AEs
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo+Vilaprisan (B1) - Treatment Emergent AEs
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Vilaprisan +Placebo (B2) - Treatment Emergent AEs
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Vilaprisan (A1) - Post Treatment AEs
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo+Vilaprisan (B1) - Post Treatment AEs
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Vilaprisan+Placebo (B2) - Post Treatment AEs
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vilaprisan (A1) - Treatment Emergent AEs
n=31 participants at risk
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that "started from the first application of study medication up to 60 calendar days after end of treatment with study medication".
|
Placebo+Vilaprisan (B1) - Treatment Emergent AEs
n=30 participants at risk
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that "started from the first application of study medication up to 60 calendar days after end of treatment with study medication".
|
Vilaprisan +Placebo (B2) - Treatment Emergent AEs
n=30 participants at risk
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that "started from the first application of study medication up to 60 calendar days after end of treatment with study medication".
|
Vilaprisan (A1) - Post Treatment AEs
n=31 participants at risk
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
|
Placebo+Vilaprisan (B1) - Post Treatment AEs
n=30 participants at risk
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
|
Vilaprisan+Placebo (B2) - Post Treatment AEs
n=30 participants at risk
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Investigations
Liver function test increased
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial neoplasm
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Myomectomy
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Salpingectomy
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Urinary cystectomy
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Hysterosalpingo-oophorectomy
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Hysterosalpingectomy
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Endometriosis ablation
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Surgical and medical procedures
Uterine leiomyoma embolisation
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
Other adverse events
| Measure |
Vilaprisan (A1) - Treatment Emergent AEs
n=31 participants at risk
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that "started from the first application of study medication up to 60 calendar days after end of treatment with study medication".
|
Placebo+Vilaprisan (B1) - Treatment Emergent AEs
n=30 participants at risk
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that "started from the first application of study medication up to 60 calendar days after end of treatment with study medication".
|
Vilaprisan +Placebo (B2) - Treatment Emergent AEs
n=30 participants at risk
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. TEAEs: defined as AEs that "started from the first application of study medication up to 60 calendar days after end of treatment with study medication".
|
Vilaprisan (A1) - Post Treatment AEs
n=31 participants at risk
Vilaprisan in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
|
Placebo+Vilaprisan (B1) - Post Treatment AEs
n=30 participants at risk
Placebo in treatment period 1 for 12 weeks, and vilaprisan in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
|
Vilaprisan+Placebo (B2) - Post Treatment AEs
n=30 participants at risk
Vilaprisan in treatment period 1 for 12 weeks, and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode. Post-treatment AEs: defined as all AEs that started from Day 61 after the end of treatment with study medication. (All AEs identified during the safety follow-up are included in this portion).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Ear and labyrinth disorders
Vertigo
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Gastrointestinal disorders
Nausea
|
9.7%
3/31 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
General disorders
Malaise
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Infections and infestations
Bacterial vaginosis
|
6.5%
2/31 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
3/31 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
13.3%
4/30 • Number of events 4 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
16.1%
5/31 • Number of events 9 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
16.7%
5/30 • Number of events 5 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.5%
2/31 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Investigations
Blood pressure increased
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
13.3%
4/30 • Number of events 4 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Nervous system disorders
Headache
|
12.9%
4/31 • Number of events 6 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
13.3%
4/30 • Number of events 4 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.5%
2/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
3.2%
1/31 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
13.3%
4/30 • Number of events 5 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Endometrial thickening
|
9.7%
3/31 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Vascular disorders
Hypertension
|
0.00%
0/31 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
|
Vascular disorders
Hot flush
|
12.9%
4/31 • Number of events 4 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
6.7%
2/30 • Number of events 2 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.3%
1/30 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
3.2%
1/31 • Number of events 1 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
0.00%
0/30 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
10.0%
3/30 • Number of events 3 • For TEAEs: started from the first application of study medication up to 60 calendar days after end of treatment with study medication. For Post-treatment AEs: started from Day 61 after the end of treatment with study medication (All AEs identified during the safety follow-up are included in this portion).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60