Trial Outcomes & Findings for Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3) (NCT NCT03400943)
NCT ID: NCT03400943
Last Updated: 2023-05-03
Results Overview
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
93 participants
Primary outcome timeframe
The last 28 days of treatment period 1
Results posted on
2023-05-03
Participant Flow
The study was conducted at 104 study centers in 9 countries worldwide between 17-Jan-2018 (first participant first visit) and 06-Apr- 2022 (last participant last visit).
Overall, 646 participants were screened. Of the 646 screened participants, 553 (85.6%) participants were not randomized to treatment. The majority of these (n=403) were screen failures. Of the 93 participants who were randomized, 79 participants received study treatment.
Participant milestones
| Measure |
Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) 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
|
23
|
23
|
24
|
23
|
|
Treatment Period 1
Treated
|
18
|
21
|
20
|
20
|
|
Treatment Period 1
COMPLETED
|
18
|
21
|
18
|
18
|
|
Treatment Period 1
NOT COMPLETED
|
5
|
2
|
6
|
5
|
|
Post-treatment Period 1
STARTED
|
18
|
0
|
18
|
18
|
|
Post-treatment Period 1
COMPLETED
|
7
|
0
|
7
|
5
|
|
Post-treatment Period 1
NOT COMPLETED
|
11
|
0
|
11
|
13
|
|
Treatment Period 2
STARTED
|
7
|
21
|
7
|
5
|
|
Treatment Period 2
COMPLETED
|
6
|
13
|
7
|
5
|
|
Treatment Period 2
NOT COMPLETED
|
1
|
8
|
0
|
0
|
|
Follow-up Period
STARTED
|
7
|
15
|
7
|
5
|
|
Follow-up Period
COMPLETED
|
6
|
15
|
7
|
5
|
|
Follow-up Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Vilaprisan (A1)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
Vilaprisan (2 mg) 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
|
0
|
0
|
1
|
|
Treatment Period 1
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
1
|
1
|
0
|
|
Treatment Period 1
Study terminated by sponsor
|
2
|
0
|
0
|
1
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
3
|
1
|
|
Treatment Period 1
Other
|
2
|
1
|
2
|
2
|
|
Post-treatment Period 1
Adverse Event
|
2
|
0
|
0
|
0
|
|
Post-treatment Period 1
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Post-treatment Period 1
Study terminated by sponsor
|
5
|
0
|
5
|
6
|
|
Post-treatment Period 1
Withdrawal by Subject
|
1
|
0
|
2
|
2
|
|
Post-treatment Period 1
Other
|
2
|
0
|
4
|
5
|
|
Treatment Period 2
Study terminated by sponsor
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Other
|
1
|
6
|
0
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Participants in safety analysis set (SAF) with endometrial thickness measured and analyzed.
Baseline characteristics by cohort
| Measure |
Vilaprisan (A1)
n=18 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=21 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=17 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=23 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and placebo in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.1 Years
STANDARD_DEVIATION 4.4 • n=18 Participants
|
43.1 Years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
42.5 Years
STANDARD_DEVIATION 5.3 • n=17 Participants
|
43.8 Years
STANDARD_DEVIATION 5.1 • n=23 Participants
|
43.2 Years
STANDARD_DEVIATION 5.1 • n=79 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=18 Participants
|
21 Participants
n=21 Participants
|
17 Participants
n=17 Participants
|
23 Participants
n=23 Participants
|
79 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=79 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=18 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
6 Participants
n=79 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=18 Participants
|
20 Participants
n=21 Participants
|
16 Participants
n=17 Participants
|
22 Participants
n=23 Participants
|
71 Participants
n=79 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=79 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=18 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=17 Participants
|
7 Participants
n=23 Participants
|
25 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=18 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=17 Participants
|
11 Participants
n=23 Participants
|
29 Participants
n=79 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=18 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=17 Participants
|
5 Participants
n=23 Participants
|
23 Participants
n=79 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=79 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=79 Participants
|
|
Endometrial thickness
|
13.6 Millimeters
STANDARD_DEVIATION 7.6 • n=18 Participants • Participants in safety analysis set (SAF) with endometrial thickness measured and analyzed.
|
11.0 Millimeters
STANDARD_DEVIATION 5.4 • n=20 Participants • Participants in safety analysis set (SAF) with endometrial thickness measured and analyzed.
|
11.9 Millimeters
STANDARD_DEVIATION 6.5 • n=17 Participants • Participants in safety analysis set (SAF) with endometrial thickness measured and analyzed.
|
10.5 Millimeters
STANDARD_DEVIATION 3.9 • n=22 Participants • Participants in safety analysis set (SAF) with endometrial thickness measured and analyzed.
|
11.7 Millimeters
STANDARD_DEVIATION 5.9 • n=77 Participants • Participants in safety analysis set (SAF) with endometrial thickness measured and analyzed.
|
PRIMARY outcome
Timeframe: The last 28 days of treatment period 1Population: FAS was analysed. FAS consists of all randomized participants, excluding randomized participants who did not start treatment period 1 due to the study being temporarily on hold, including 84 participants. Participants were analyzed as randomized.
Amenorrhea was defined as menstrual blood loss (MBL) \<2 mL during the last 28 days of treatment measured by the alkaline hematin (AH) method.
Outcome measures
| Measure |
Vilaprisan (A1)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=23 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=20 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=21 Participants
Vilaprisan (2 mg) 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
|
16 Participants
|
20 Participants
|
4 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: The last 28 days of treatment period 1 and treatment period 2Population: FAS population was analysed.
HMB response was defined as MBL \<80 mL during the last 28 days of treatment and \>50% reduction from baseline based on AH-method.
Outcome measures
| Measure |
Vilaprisan (A1)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=23 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=20 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=21 Participants
Vilaprisan (2 mg) 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
|
17 Participants
|
20 Participants
|
8 Participants
|
17 Participants
|
|
Number of Participants With Heavy Menstrual Bleeding (HMB) Response
Treatment period 2
|
6 Participants
|
14 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)Population: FAS population was analysed. 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. For treatment arm Vilaprisan (A2), the combined data of treatment period 1 and treatment period 2 were entered.
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).
Outcome measures
| Measure |
Vilaprisan (A1)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=23 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=20 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=21 Participants
Vilaprisan (2 mg) 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: not applicable. For treatment arm Vilaprisan (A2), the combined data of treatment period 1 and treatment period 2 were entered.
|
NA Days
NA indicates that the value cannot be estimated due to censored data.
|
6 Days
Interval 1.0 to 46.0
|
|
Time to Onset of Amenorrhea
Treatment periods 1 and 2 combined
|
NA Days
NA: not applicable.
|
9 Days
Interval 3.0 to 107.0
|
NA Days
NA: not applicable.
|
NA Days
NA: not applicable.
|
|
Time to Onset of Amenorrhea
Treatment Period 2
|
21 Days
Interval 2.0 to 32.0
|
NA Days
NA: not applicable. For treatment arm Vilaprisan (A2), the combined data of treatment period 1 and treatment period 2 were entered.
|
2 Days
Interval 1.0 to
NA indicates that the value cannot be estimated due to censored data.
|
NA Days
NA indicates that the value cannot 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 was analysed. 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. For treatment arm Vilaprisan (A2), the combined data of treatment period 1 and treatment period 2 were entered.
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 based on AH-method.
Outcome measures
| Measure |
Vilaprisan (A1)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=23 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=20 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=21 Participants
Vilaprisan (2 mg) 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 2.0
|
NA Days
NA: not applicable. For treatment arm Vilaprisan (A2), the combined data of treatment period 1 and treatment period 2 were entered.
|
NA Days
Interval 53.0 to
NA indicates that the value cannot be estimated due to censored data.
|
1 Days
Interval 1.0 to 1.0
|
|
Time to Onset of Controlled Bleeding
Treatment period 2
|
1 Days
Interval 1.0 to 1.0
|
NA Days
NA: not applicable. For treatment arm Vilaprisan (A2), the combined data of treatment period 1 and treatment period 2 were entered.
|
1 Days
Interval 1.0 to 2.0
|
NA Days
NA indicates that the value cannot be estimated due to censored data.
|
|
Time to Onset of Controlled Bleeding
Treatment periods 1 and 2 combined
|
NA Days
NA: not applicable.
|
1 Days
Interval 1.0 to 7.0
|
NA Days
NA: not applicable.
|
NA Days
NA: not applicable.
|
SECONDARY outcome
Timeframe: The last 28 days of treatment period 1 and treatment period 2Population: FAS population was analysed.
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 Uterine Fibroid Daily Bleeding Diary (UF-DBD).
Outcome measures
| Measure |
Vilaprisan (A1)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=23 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=20 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=21 Participants
Vilaprisan (2 mg) 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 1
|
16 Participants
|
20 Participants
|
4 Participants
|
15 Participants
|
|
Number of Participants With Absence of Bleeding (Spotting Allowed)
Treatment period 2
|
6 Participants
|
13 Participants
|
6 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeks after end of treatmentPopulation: Participants in safety analysis set with adequate tissue were analyzed.
Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia WHO 2014, no atypia or Hyperplasia WHO 2014, atypia and Endometrial Polyps.
Outcome measures
| Measure |
Vilaprisan (A1)
n=18 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=17 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=22 Participants
Vilaprisan (2 mg) 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 Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Malignant Neoplasm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Benign Endometrium
|
17 Participants
|
20 Participants
|
17 Participants
|
22 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Hyperplasia WHO 2014, no atypia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Hyperplasia WHO 2014, atypia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Endometrial Histology Findings by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
Endometrial Polyps
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment phase (up to 2 weeks after end of treatment) and follow-up phase (starts on the day after the end of the treatment until the last study visit [up to approximately 2 years])Population: Participants in SAF with endometrial thickness measured and analyzed.
Ultrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline in endometrial thickness was provided in below table.
Outcome measures
| Measure |
Vilaprisan (A1)
n=18 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan (A2)
n=20 Participants
Vilaprisan (2 mg) in treatment period 1 for 12 weeks and in treatment period 2 for 12 weeks without a break.
|
Placebo+Vilaprisan (B1)
n=17 Participants
Placebo in treatment period 1 for 12 weeks, and vilaprisan (2 mg) in treatment period 2 for 12 weeks, separated by 1 bleeding episode.
|
Vilaprisan+Placebo (B2)
n=22 Participants
Vilaprisan (2 mg) 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 phase
|
-2.2 Millimeters
Standard Deviation 3.0
|
-1.3 Millimeters
Standard Deviation 4.3
|
-1.8 Millimeters
Standard Deviation 4.9
|
-1.8 Millimeters
Standard Deviation 3.4
|
|
Change From Baseline of Endometrial Thickness
Follow-up phase
|
-3.0 Millimeters
Standard Deviation 4.6
|
-0.5 Millimeters
Standard Deviation 3.8
|
-3.1 Millimeters
Standard Deviation 4.0
|
-1.8 Millimeters
Standard Deviation 3.7
|
Adverse Events
Vilaprisan - Treatment Emergent AEs
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo - Treatment Emergent AEs
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Vilaprisan (A1) - Post Treatment AEs
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Vilaprisan (A2) - Post Treatment AEs
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo+ Vilaprisan (B1) - Post Treatment AEs
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Vilaprisan+ Placebo (B2) - Post Treatment AEs
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vilaprisan - Treatment Emergent AEs
n=69 participants at risk
Participants who received the treatment of Vilaprisan in the study - Treatment emergent AEs.
|
Placebo - Treatment Emergent AEs
n=22 participants at risk
Participants who received placebo in the study - Treatment emergent AEs.
|
Vilaprisan (A1) - Post Treatment AEs
n=18 participants at risk
Vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode - Post treatment AEs.
|
Vilaprisan (A2) - Post Treatment AEs
n=21 participants at risk
Vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break - Post treatment AEs.
|
Placebo+ Vilaprisan (B1) - Post Treatment AEs
n=17 participants at risk
Placebo, 1 treatment period of 12 weeks, and Vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode - Post treatment AEs.
|
Vilaprisan+ Placebo (B2) - Post Treatment AEs
n=23 participants at risk
Vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 Weeks, separated by 1 bleeding episode - Post treatment AEs.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
General disorders
Chest pain
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Investigations
Cystoscopy
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
9.5%
2/21 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.5%
1/22 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
8.7%
2/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Surgical and medical procedures
Myomectomy
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
11.8%
2/17 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Surgical and medical procedures
Renal lesion excision
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Surgical and medical procedures
Salpingectomy
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Surgical and medical procedures
Endometrial ablation
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Surgical and medical procedures
Hysterosalpingectomy
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
Other adverse events
| Measure |
Vilaprisan - Treatment Emergent AEs
n=69 participants at risk
Participants who received the treatment of Vilaprisan in the study - Treatment emergent AEs.
|
Placebo - Treatment Emergent AEs
n=22 participants at risk
Participants who received placebo in the study - Treatment emergent AEs.
|
Vilaprisan (A1) - Post Treatment AEs
n=18 participants at risk
Vilaprisan (2 mg), 2 treatment periods of 12 weeks, separated by 1 bleeding episode - Post treatment AEs.
|
Vilaprisan (A2) - Post Treatment AEs
n=21 participants at risk
Vilaprisan (2 mg), 2 treatment periods of 12 weeks without a break - Post treatment AEs.
|
Placebo+ Vilaprisan (B1) - Post Treatment AEs
n=17 participants at risk
Placebo, 1 treatment period of 12 weeks, and Vilaprisan (2 mg), 1 treatment period of 12 weeks, separated by 1 bleeding episode - Post treatment AEs.
|
Vilaprisan+ Placebo (B2) - Post Treatment AEs
n=23 participants at risk
Vilaprisan (2 mg), 1 treatment period of 12 weeks, and placebo, 1 treatment period of 12 Weeks, separated by 1 bleeding episode - Post treatment AEs.
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Blood and lymphatic system disorders
Anaemia
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0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
18.2%
4/22 • Number of events 4 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
22.2%
4/18 • Number of events 4 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
9.5%
2/21 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
13.0%
3/23 • Number of events 3 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
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|
Cardiac disorders
Tachycardia
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0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
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Endocrine disorders
Cushing's syndrome
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0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
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5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Eye disorders
Eye swelling
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
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5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
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Gastrointestinal disorders
Abdominal discomfort
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2.9%
2/69 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
4/69 • Number of events 4 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
22.7%
5/22 • Number of events 7 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.8%
4/69 • Number of events 6 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
9/69 • Number of events 10 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
13.6%
3/22 • Number of events 3 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
General disorders
Chest pain
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
General disorders
Fatigue
|
5.8%
4/69 • Number of events 5 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
13.6%
3/22 • Number of events 3 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
General disorders
Pyrexia
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.5%
1/22 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
4/69 • Number of events 5 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.2%
5/69 • Number of events 6 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Investigations
Blood pressure increased
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Investigations
Blood testosterone increased
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
8.7%
2/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Investigations
Cortisol increased
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
27.8%
5/18 • Number of events 5 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
4/69 • Number of events 4 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.5%
1/22 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
2/69 • Number of events 3 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Nervous system disorders
Headache
|
13.0%
9/69 • Number of events 10 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
8.7%
2/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Psychiatric disorders
Poor quality sleep
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.9%
2/69 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.5%
1/22 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 3 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
5.8%
4/69 • Number of events 6 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.5%
1/22 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.5%
1/22 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
11.1%
2/18 • Number of events 4 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.8%
1/21 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/69 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.9%
2/69 • Number of events 2 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.6%
1/18 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Vascular disorders
Hypertension
|
1.4%
1/69 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
5.9%
1/17 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
4.3%
1/23 • Number of events 1 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
|
Vascular disorders
Hot flush
|
8.7%
6/69 • Number of events 6 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/22 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/18 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/21 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/17 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
0.00%
0/23 • For TEAEs: From the first application of study medication up to 60 calendar days after end of treatment with study medication, an average of 26 weeks. For Post-treatment AEs: All AEs that started from Day 61 after the end of treatment with study medication, up to 73 weeks.
For TEAEs: participant will be counted for both treatment groups if she received different treatments (vilaprisan or placebo) in the two treatment periods. SAF population was used. For Post-treatment AEs: Mistakes in the administration of study drug might have affected the assignment to treatment. In general, participants who received a different study drug to the one they were randomized to, were assigned to the treatment most often received. SAF population was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER