Trial Outcomes & Findings for A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause (NCT NCT06112756)
NCT ID: NCT06112756
Last Updated: 2025-11-10
Results Overview
WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
From baseline until week 4
Results posted on
2025-11-10
Participant Flow
The study was conducted at 39 study centers, of which 30 centers had randomized participants in Europe and the US. In the US, separate sleep laboratories were used by 9 sites that did not have polysomnography (PSG) capability.
Out of the 338 screened participants, 110 were randomized and received treatment, and 103 participants completed the study. Among the 228 participants who did not proceed to randomization, screening failure was the primary reason (223 participants).
Participant milestones
| Measure |
Elinzanetant
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
52
|
51
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Elinzanetant
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Subject took an out of state job and had to early terminate
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Baseline characteristics by cohort
| Measure |
Elinzanetant
n=55 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=55 Participants
2 soft gel capsules orally once daily for 12 weeks
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
54.9 Years
STANDARD_DEVIATION 4.7 • n=20 Participants
|
54.8 Years
STANDARD_DEVIATION 4.6 • n=40 Participants
|
|
Sex/Gender, Customized
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=20 Participants
|
110 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
45 Participants
n=20 Participants
|
85 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Weight (kg)
|
75.77 Kilograms
STANDARD_DEVIATION 12.45 • n=5 Participants
|
74.41 Kilograms
STANDARD_DEVIATION 10.61 • n=20 Participants
|
75.09 Kilograms
STANDARD_DEVIATION 11.53 • n=40 Participants
|
|
Height (cm)
|
164.64 Centimeters
STANDARD_DEVIATION 7.08 • n=5 Participants
|
164.18 Centimeters
STANDARD_DEVIATION 7.01 • n=20 Participants
|
164.41 Centimeters
STANDARD_DEVIATION 7.02 • n=40 Participants
|
|
Body Mass Index (kg/m2)
|
27.97 Kilogram per square meter
STANDARD_DEVIATION 4.36 • n=5 Participants
|
27.63 Kilogram per square meter
STANDARD_DEVIATION 3.75 • n=20 Participants
|
27.80 Kilogram per square meter
STANDARD_DEVIATION 4.05 • n=40 Participants
|
|
Average weekly frequency of moderate to severe HF
<35 moderate to severe HF per week
|
13 Participants
n=5 Participants
|
11 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Average weekly frequency of moderate to severe HF
>=35 - <50 moderate to severe HF per week
|
11 Participants
n=5 Participants
|
13 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Average weekly frequency of moderate to severe HF
>=50 moderate to severe HF per week
|
31 Participants
n=5 Participants
|
31 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Smoking
Never
|
40 Participants
n=5 Participants
|
42 Participants
n=20 Participants
|
82 Participants
n=40 Participants
|
|
Smoking
Former
|
5 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Smoking
Current
|
10 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Alcohol consumption
Abstinent
|
14 Participants
n=5 Participants
|
25 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Alcohol consumption
Light
|
41 Participants
n=5 Participants
|
30 Participants
n=20 Participants
|
71 Participants
n=40 Participants
|
|
Caffeine consumption (mg) per day
|
142.07 Miligrams
STANDARD_DEVIATION 129.87 • n=5 Participants
|
119.79 Miligrams
STANDARD_DEVIATION 99.53 • n=20 Participants
|
131.43 Miligrams
STANDARD_DEVIATION 116.26 • n=40 Participants
|
|
Level of education
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Level of education
College or university education
|
32 Participants
n=5 Participants
|
34 Participants
n=20 Participants
|
66 Participants
n=40 Participants
|
|
Level of education
Professional certification
|
3 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Level of education
Attending college
|
5 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Level of education
Other
|
14 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From baseline until week 4WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.
Outcome measures
| Measure |
Elinzanetant
n=47 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=47 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG)
|
-23.50 Minutes
Standard Error 4.63
|
-1.01 Minutes
Standard Error 4.68
|
SECONDARY outcome
Timeframe: From baseline until week 12WASO is defined as total time (min) spent awake from onset of persistent sleep to lights on. Persistent sleep is defined as 20 consecutive epochs (10 min) of non wakefulness. Smaller WASO values indicate shorter periods of wakefulness after sleep onset.
Outcome measures
| Measure |
Elinzanetant
n=46 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=43 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in WASO at Week 12 as Measured by PSG
|
-16.48 Minutes
Standard Error 4.64
|
-15.54 Minutes
Standard Error 4.76
|
SECONDARY outcome
Timeframe: From baseline to Week 4Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.
Outcome measures
| Measure |
Elinzanetant
n=52 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=53 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Sleep Efficiency (SE) at Week 4 as Measured by PSG
|
6.85 Percentage
Standard Deviation 8.07
|
1.13 Percentage
Standard Deviation 10.31
|
SECONDARY outcome
Timeframe: From baseline to week 12Sleep efficiency is defined as the percentage of time spent asleep while in bed. (Total sleep time / time in bed) x 100. Higher sleep efficiency values indicate more time spent asleep.
Outcome measures
| Measure |
Elinzanetant
n=52 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=51 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in SE at Week 12 as Measured by PSG
|
5.15 Percentage
Standard Deviation 9.68
|
4.67 Percentage
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: From baseline until week 4Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Outcome measures
| Measure |
Elinzanetant
n=45 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=43 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 4
|
-11.17 T-Score
Standard Deviation 8.04
|
-6.59 T-Score
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: From baseline until week 12Participants' responses to the 8 items of the instrument are scored on a 1-5 numeric rating scale and will be aggregated to derive total raw scores ranging from 8-40 with higher scores indicating greater severity of sleep disturbance. These total raw scores will be converted into T-scores for comparison with population norms (United States general population). T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Outcome measures
| Measure |
Elinzanetant
n=27 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=31 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline inPatient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total T-score at Week 12
|
-14.66 T-Score
Standard Deviation 9.36
|
-6.65 T-Score
Standard Deviation 8.29
|
SECONDARY outcome
Timeframe: From baseline until week 4Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.
Outcome measures
| Measure |
Elinzanetant
n=48 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=50 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in Insomnia Severity Index (ISI) Total Score at Week 4
|
-7.8 Scores on a scale
Standard Deviation 6.0
|
-4.7 Scores on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: From baseline until week 12Insomnia Severity Index (ISI): The ISI is a 7-item tool that measures insomnia severity over the past two weeks (Bastien et al., 2001). It evaluates sleep onset, maintenance issues, early morning awakenings, satisfaction with sleep, noticeability of problems, distress caused, and daytime interference. Scoring: The ISI uses a 5-point Likert scale (0 to 4). Item scores are summed to yield a total score ranging from 0 to 28. Severity Categories: 0-7: No clinically significant insomnia (better outcome) 8-14: Subthreshold insomnia (moderate outcome) 15-21: Clinical insomnia (moderate severity) (worse outcome) 22-28: Clinical insomnia (severe) (worse outcome) Interpretation: Higher total scores indicate worse insomnia severity, while lower scores indicate better sleep quality. The total score is the sum of individual item scores.
Outcome measures
| Measure |
Elinzanetant
n=42 Participants
120 mg (2x 60 mg soft gel capsules) of elinzanetant orally once daily for 12 weeks
|
Placebo
n=47 Participants
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Change From Baseline in ISI Total Score at Week 12
|
-9.8 ISI total score
Standard Deviation 6.4
|
-6.9 ISI total score
Standard Deviation 5.6
|
Adverse Events
BAY 3427080 / Elinzanetant
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BAY 3427080 / Elinzanetant
n=55 participants at risk
Soft gel capsule, two capsules of 60 mg
|
Placebo
n=55 participants at risk
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
Other adverse events
| Measure |
BAY 3427080 / Elinzanetant
n=55 participants at risk
Soft gel capsule, two capsules of 60 mg
|
Placebo
n=55 participants at risk
2 soft gel capsules orally once daily for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
General disorders
Fatigue
|
7.3%
4/55 • Number of events 4 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Bronchitis
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
5.5%
3/55 • Number of events 3 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Gastroenteritis viral
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Influenza
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Pharyngitis
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Urinary tract infection
|
3.6%
2/55 • Number of events 3 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
Viral infection
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Infections and infestations
COVID-19
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Glycosylated haemoglobin increased
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Weight increased
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Thyroxine free increased
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Hepatic enzyme increased
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Investigations
Liver function test increased
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Nervous system disorders
Headache
|
9.1%
5/55 • Number of events 9 • After the first study intervention up to 113 days until the last follow-up visit
|
10.9%
6/55 • Number of events 7 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Nervous system disorders
Migraine
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Nervous system disorders
Somnolence
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Psychiatric disorders
Stress
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Vascular disorders
Hypertension
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
1.8%
1/55 • Number of events 1 • After the first study intervention up to 113 days until the last follow-up visit
|
|
Vascular disorders
Hot flush
|
0.00%
0/55 • After the first study intervention up to 113 days until the last follow-up visit
|
3.6%
2/55 • Number of events 2 • After the first study intervention up to 113 days until the last follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60