Trial Outcomes & Findings for A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause (NCT NCT05030584)
NCT ID: NCT05030584
Last Updated: 2025-12-01
Results Overview
The HFDD items assess the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF are defined as a "sensation of heat without sweating", moderate HF are defined as a "sensation of heat with sweating, but able to continue activity", and severe HF are defined as a "sensation of heat with sweating, causing cessation (stopping) of activity".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
628 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2025-12-01
Participant Flow
The study was conducted at 75 study centers in North America and in several countries in Europe, between 27-Aug-2021 (first participant first visit) and 12-Feb-2024 (last participant last visit).
A total of 1524 patients were screened, of whom 628 were randomized.
Participant milestones
| Measure |
Elinzanetant (BAY3427080)
Participants received 120 mg elinzanetant orally once daily.
|
Placebo
Participants received matching placebo orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
313
|
315
|
|
Overall Study
Received Treatment
|
312
|
315
|
|
Overall Study
COMPLETED
|
222
|
231
|
|
Overall Study
NOT COMPLETED
|
91
|
84
|
Reasons for withdrawal
| Measure |
Elinzanetant (BAY3427080)
Participants received 120 mg elinzanetant orally once daily.
|
Placebo
Participants received matching placebo orally once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Non-Compliance with Study Drug
|
2
|
3
|
|
Overall Study
Other reason
|
4
|
3
|
|
Overall Study
Physician Decision
|
1
|
4
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Randomized by Mistake
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
21
|
28
|
|
Overall Study
Technical Problems
|
0
|
1
|
|
Overall Study
Completed post-treatment/FU visits
|
41
|
31
|
Baseline Characteristics
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
Baseline characteristics by cohort
| Measure |
Elinzanetant (BAY3427080)
n=313 Participants
Participants received 120 mg elinzanetant orally once daily.
|
Placebo
n=315 Participants
Participants received matching placebo orally once daily.
|
Total
n=628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 Years
STANDARD_DEVIATION 4.7 • n=121 Participants
|
54.9 Years
STANDARD_DEVIATION 5.0 • n=122 Participants
|
54.7 Years
STANDARD_DEVIATION 4.8 • n=243 Participants
|
|
Sex: Female, Male
Female
|
313 Participants
n=121 Participants
|
315 Participants
n=122 Participants
|
628 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=121 Participants
|
34 Participants
n=122 Participants
|
68 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
266 Participants
n=121 Participants
|
273 Participants
n=122 Participants
|
539 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
21 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=121 Participants
|
44 Participants
n=122 Participants
|
95 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
240 Participants
n=121 Participants
|
253 Participants
n=122 Participants
|
493 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=121 Participants
|
15 Participants
n=122 Participants
|
34 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: All randomized participants with data available at the time of evaluation.
The HFDD items assess the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF are defined as a "sensation of heat without sweating", moderate HF are defined as a "sensation of heat with sweating, but able to continue activity", and severe HF are defined as a "sensation of heat with sweating, causing cessation (stopping) of activity".
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=312 Participants
Participants received 120 mg elinzanetant orally once daily.
|
Placebo
n=315 Participants
Participants received matching placebo orally once daily.
|
|---|---|---|
|
Mean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD])
Baseline
|
6.71 Number of HF
Standard Deviation 7.15
|
6.81 Number of HF
Standard Deviation 6.15
|
|
Mean Change in Frequency of Moderate to Severe Hot Flashes (HFs) From Baseline to Week 12 (Assessed by Hot Flash Daily Diary [HFDD])
Change from Baseline
|
-5.40 Number of HF
Standard Deviation 7.29
|
-3.50 Number of HF
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: Baseline to Week 56Population: All randomized participants with data available at the time of evaluation.
The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from "not at all", "never" or "very poor" to "very much", "always" or "very good". Four of the items are scored reversely. Individual item scores are aggregated to total raw scores which range from 8 to 40. Total raw scores are converted into T-scores for comparison with population norms, with a mean of 50 and standard deviation of 10. T-scores range from 28.9 to 76.5. For both raw and T-scores higher scores indicate greater severity of sleep disturbance. According to available score cut points from PROMIS developers, T-scores can be interpreted as indicating mild (55-59), moderate (60-69), or severe (\>70) sleep disturbance.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=270 Participants
Participants received 120 mg elinzanetant orally once daily.
|
Placebo
n=274 Participants
Participants received matching placebo orally once daily.
|
|---|---|---|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Baseline
|
57.35 T-score
Standard Deviation 6.66
|
57.96 T-score
Standard Deviation 7.63
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 1
|
-5.19 T-score
Standard Deviation 7.17
|
-1.60 T-score
Standard Deviation 5.39
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 2
|
-6.78 T-score
Standard Deviation 7.96
|
-2.89 T-score
Standard Deviation 6.78
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 3
|
-7.67 T-score
Standard Deviation 8.24
|
-3.34 T-score
Standard Deviation 6.88
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 4
|
-7.70 T-score
Standard Deviation 8.27
|
-3.81 T-score
Standard Deviation 6.98
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 8
|
-7.98 T-score
Standard Deviation 8.58
|
-4.36 T-score
Standard Deviation 7.64
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 12
|
-7.97 T-score
Standard Deviation 8.04
|
-5.26 T-score
Standard Deviation 8.02
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 18
|
-8.83 T-score
Standard Deviation 9.05
|
-5.77 T-score
Standard Deviation 7.82
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 24
|
-9.77 T-score
Standard Deviation 9.00
|
-5.85 T-score
Standard Deviation 7.79
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 36
|
-9.20 T-score
Standard Deviation 8.74
|
-5.88 T-score
Standard Deviation 8.38
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 52
|
-9.36 T-score
Standard Deviation 8.41
|
-5.73 T-score
Standard Deviation 7.91
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score From Baseline Over Time.
Change from baseline to Week 56 (Follow-up)
|
-5.83 T-score
Standard Deviation 8.71
|
-5.38 T-score
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: Baseline to Week 56Population: All randomized participants with data available at the time of evaluation.
The MENQOL questionnaire is comprised of 29 items assessing the presence of menopausal symptoms and the impact of menopause on health-related quality of life over the past week. The items assess four domains of symptoms and functioning: Vasomotor functioning, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If they select yes, they rate how bothered they were by the symptom using a six-point verbal descriptor scale, with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=262 Participants
Participants received 120 mg elinzanetant orally once daily.
|
Placebo
n=264 Participants
Participants received matching placebo orally once daily.
|
|---|---|---|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Baseline
|
4.10 Scores on a scale
Standard Deviation 1.21
|
4.41 Scores on a scale
Standard Deviation 1.37
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 4
|
-0.94 Scores on a scale
Standard Deviation 1.22
|
-0.67 Scores on a scale
Standard Deviation 1.21
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 8
|
-1.07 Scores on a scale
Standard Deviation 1.24
|
-0.86 Scores on a scale
Standard Deviation 1.18
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 12
|
-1.10 Scores on a scale
Standard Deviation 1.25
|
-0.95 Scores on a scale
Standard Deviation 1.32
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 18
|
-1.30 Scores on a scale
Standard Deviation 1.32
|
-1.11 Scores on a scale
Standard Deviation 1.40
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 24
|
-1.25 Scores on a scale
Standard Deviation 1.17
|
-1.15 Scores on a scale
Standard Deviation 1.37
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 36
|
-1.18 Scores on a scale
Standard Deviation 1.21
|
-1.02 Scores on a scale
Standard Deviation 1.42
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 52
|
-1.30 Scores on a scale
Standard Deviation 1.33
|
-1.11 Scores on a scale
Standard Deviation 1.35
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline Over Time
Change from baseline to Week 56 (Follow-up)
|
-0.82 Scores on a scale
Standard Deviation 1.25
|
-1.04 Scores on a scale
Standard Deviation 1.59
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 73 other events
Deaths: 0 deaths
Elinzanetant (BAY3427080)
Serious events: 13 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=314 participants at risk
Participants received matching placebo orally once daily.
|
Elinzanetant (BAY3427080)
n=313 participants at risk
Participants received 120 mg elinzanetant orally once daily.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.32%
1/314 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.00%
0/313 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Infections and infestations
Fusobacterium infection
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Infections and infestations
Infected bite
|
0.32%
1/314 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.00%
0/313 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Infections and infestations
Meningitis meningococcal
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.32%
1/314 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.00%
0/313 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Investigations
Blood glucose increased
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.32%
1/314 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Encephalitis toxic
|
0.32%
1/314 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.00%
0/313 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Hemiparaesthesia
|
0.32%
1/314 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.00%
0/313 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Syncope
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/314 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
0.32%
1/313 • Number of events 1 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
Other adverse events
| Measure |
Placebo
n=314 participants at risk
Participants received matching placebo orally once daily.
|
Elinzanetant (BAY3427080)
n=313 participants at risk
Participants received 120 mg elinzanetant orally once daily.
|
|---|---|---|
|
General disorders
Fatigue
|
2.9%
9/314 • Number of events 9 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
6.7%
21/313 • Number of events 23 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Infections and infestations
COVID-19
|
10.2%
32/314 • Number of events 32 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
7.0%
22/313 • Number of events 22 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
21/314 • Number of events 23 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
4.8%
15/313 • Number of events 16 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Headache
|
7.0%
22/314 • Number of events 51 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
9.6%
30/313 • Number of events 51 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
|
Nervous system disorders
Somnolence
|
1.3%
4/314 • Number of events 4 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
5.1%
16/313 • Number of events 18 • Adverse events tables: up to 14 days from the last drug intake, up to 54 weeks. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 62 weeks.
1 participant who was assigned to the elinzanetant arm received no study drug and was excluded from the SAF. In addition, 1 participant who was assigned to the placebo arm received a kit containing elinzanetant at the Week 8 visit and is therefore assigned to the elinzanetant arm in the SAF. SAF: Elinzanetant=313, Placebo=314.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will submit material for public dissemination to the sponsor at least 60 days prior to submission. The PI agrees that all reasonable comments made by the sponsor will be incorporated into the publication. The sponsor can request that the publication be delayed for up to 6 months and for an exceptional additional delay, if proprietary information and/or Intellectual Property Rights and Know-How might otherwise be compromised or lost.
- Publication restrictions are in place
Restriction type: OTHER