Trial Outcomes & Findings for A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (NCT NCT05587296)
NCT ID: NCT05587296
Last Updated: 2026-02-03
Results Overview
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
474 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2026-02-03
Participant Flow
The study was conducted at 97 study centers, predominantly in Europe and at several centers in Canada, Israel, Kazakhstan and United Kingdom starting 14-Oct-2022 (first participant first visit), reaching primary completion on 29-Jan-2024.
Out of 758 screened participants, 474 were randomized.
Participant milestones
| Measure |
Elinzanetant (BAY3427080)
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Overall Study
STARTED
|
316
|
158
|
|
Overall Study
COMPLETED
|
262
|
133
|
|
Overall Study
NOT COMPLETED
|
54
|
25
|
Reasons for withdrawal
| Measure |
Elinzanetant (BAY3427080)
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
7
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
|
Overall Study
miscellaneous
|
3
|
6
|
|
Overall Study
Did not complete study treatment but completed post-treatment phase/follow-up
|
19
|
8
|
Baseline Characteristics
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 7.5 • n=13 Participants
|
51.5 years
STANDARD_DEVIATION 6.7 • n=15 Participants
|
51.0 years
STANDARD_DEVIATION 7.3 • n=28 Participants
|
|
Sex: Female, Male
Female
|
316 Participants
n=13 Participants
|
158 Participants
n=15 Participants
|
474 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=13 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=13 Participants
|
5 Participants
n=15 Participants
|
12 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
289 Participants
n=13 Participants
|
143 Participants
n=15 Participants
|
432 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=13 Participants
|
10 Participants
n=15 Participants
|
30 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: FAS
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])
Baseline
|
11.41 hot flashes per day
Standard Deviation 6.89
|
11.52 hot flashes per day
Standard Deviation 6.43
|
|
Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])
Change from Baseline Week 4
|
-6.51 hot flashes per day
Standard Deviation 6.13
|
-3.04 hot flashes per day
Standard Deviation 5.04
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: FAS
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Frequency of Moderate to Severe HFs From Baseline to Week 12 (Assessed by HFDD)
Baseline
|
11.41 hot flashes per day
Standard Deviation 6.89
|
11.52 hot flashes per day
Standard Deviation 6.43
|
|
Mean Change in Frequency of Moderate to Severe HFs From Baseline to Week 12 (Assessed by HFDD)
Change from Baseline week 12
|
-7.76 hot flashes per day
Standard Deviation 6.17
|
-4.20 hot flashes per day
Standard Deviation 6.06
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: FAS
In the HFDD, the severity of HFs was categorized as: 1 = mild, 2 = moderate, and 3 = severe; therefore, a decrease in the HF severity score indicates an improvement. The mean daily severity during treatment was calculated for the available days as \[(1 x number of mild HF) + (2 x number of moderate HF) + (3 x number of severe HF)\] / (total number of mild, moderate and severe hot flashes on that day). When no HFs were reported for a particular day, the mean severity for that day was set to 0. The mean daily severity during baseline was calculated for the available days as \[(2 x number of moderate HF) + (3 x number of severe HF)\] / (total number of moderate to severe hot flashes on that day).
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD).
Baseline
|
2.49 score*hot flashes/total of hot flashes
Standard Deviation 0.24
|
2.49 score*hot flashes/total of hot flashes
Standard Deviation 0.22
|
|
Mean Change in Severity of Moderate to Severe HF From Baseline to Week 4 (Assessed by HFDD).
Change from Baseline week 4
|
-0.73 score*hot flashes/total of hot flashes
Standard Deviation 0.60
|
-0.43 score*hot flashes/total of hot flashes
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: FAS
In the HFDD, the severity of HFs was categorized as: 1 = mild, 2 = moderate, and 3 = severe; therefore, a decrease in the HF severity score indicates an improvement. The mean daily severity during treatment was calculated for the available days as \[(1 x number of mild HF) + (2 x number of moderate HF) + (3 x number of severe HF)\] / (total number of mild, moderate and severe hot flashes on that day). When no HFs were reported for a particular day, the mean severity for that day was set to 0. The mean daily severity during baseline was calculated for the available days as \[(2 x number of moderate HF) + (3 x number of severe HF)\] / (total number of moderate to severe hot flashes on that day).
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD)
Baseline
|
2.49 score*hot flashes/total of hot flashes
Standard Deviation 0.24
|
2.49 score*hot flashes/total of hot flashes
Standard Deviation 0.22
|
|
Mean Change in Severity of Moderate to Severe HF From Baseline to Week 12 (Assessed by HFDD)
Change from Baseline week 12
|
-0.98 score*hot flashes/total of hot flashes
Standard Deviation 0.72
|
-0.53 score*hot flashes/total of hot flashes
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: Baseline to Week 1Population: FAS
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD)
Baseline
|
11.41 hot flashes per day
Standard Deviation 6.89
|
11.52 hot flashes per day
Standard Deviation 6.43
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline to Week 1 (Assessed by HFDD)
Change from baseline week 1
|
-4.04 hot flashes per day
Standard Deviation 5.11
|
-1.76 hot flashes per day
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: Baseline to Week 50Population: FAS
Participants' assessments of HF were recorded electronically twice daily using the sponsor developed Hot Flash Daily Diary (HFDD). The HFDD was completed in the morning after waking up (morning diary) and each evening at bedtime (evening diary) on the hand-held device. The HFDD items assessed the number of mild, moderate, and severe HF experienced during the day and during the night. Mild HF was defined as a "sensation of heat without sweating", moderate HF was defined as a "sensation of heat with sweating, but able to continue activity", and severe HF was defined as a "sensation of heat with sweating, causing cessation (stopping) of activity". Mean daily frequency is calculated as total number of moderate to severe HF during that week divided by the total number of available days with data during that week.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Baseline
|
11.41 hot flashes per day
Standard Deviation 6.89
|
11.52 hot flashes per day
Standard Deviation 6.43
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 1
|
-4.04 hot flashes per day
Standard Deviation 5.11
|
-1.76 hot flashes per day
Standard Deviation 3.83
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 2
|
-5.55 hot flashes per day
Standard Deviation 5.88
|
-2.78 hot flashes per day
Standard Deviation 4.31
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 3
|
-6.19 hot flashes per day
Standard Deviation 5.94
|
-2.96 hot flashes per day
Standard Deviation 4.82
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 4
|
-6.51 hot flashes per day
Standard Deviation 6.13
|
-3.04 hot flashes per day
Standard Deviation 5.04
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 5
|
-6.84 hot flashes per day
Standard Deviation 5.92
|
-3.35 hot flashes per day
Standard Deviation 5.06
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 6
|
-7.04 hot flashes per day
Standard Deviation 6.20
|
-3.69 hot flashes per day
Standard Deviation 5.37
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 7
|
-7.32 hot flashes per day
Standard Deviation 6.05
|
-3.96 hot flashes per day
Standard Deviation 5.60
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 8
|
-7.45 hot flashes per day
Standard Deviation 6.25
|
-4.02 hot flashes per day
Standard Deviation 5.53
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 9
|
-7.49 hot flashes per day
Standard Deviation 6.29
|
-4.00 hot flashes per day
Standard Deviation 5.64
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 10
|
-7.48 hot flashes per day
Standard Deviation 6.03
|
-3.88 hot flashes per day
Standard Deviation 5.82
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 11
|
-7.74 hot flashes per day
Standard Deviation 6.16
|
-4.08 hot flashes per day
Standard Deviation 5.94
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 12
|
-7.76 hot flashes per day
Standard Deviation 6.17
|
-4.20 hot flashes per day
Standard Deviation 6.06
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 25
|
-8.98 hot flashes per day
Standard Deviation 6.12
|
-9.60 hot flashes per day
Standard Deviation 6.04
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 26
|
-8.93 hot flashes per day
Standard Deviation 6.13
|
-9.55 hot flashes per day
Standard Deviation 6.14
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 35
|
-9.05 hot flashes per day
Standard Deviation 6.16
|
-9.30 hot flashes per day
Standard Deviation 6.23
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 36
|
-8.94 hot flashes per day
Standard Deviation 6.15
|
-9.13 hot flashes per day
Standard Deviation 6.25
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 49
|
-8.77 hot flashes per day
Standard Deviation 5.89
|
-9.02 hot flashes per day
Standard Deviation 6.17
|
|
Mean Change in Frequency of Moderate to Severe HF From Baseline Over Time (Assessed by HFDD)
Change from baseline to Week 50
|
-8.72 hot flashes per day
Standard Deviation 6.22
|
-8.90 hot flashes per day
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: FAS
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=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total Score From Baseline to Week 12
Baseline
|
60.60 T-Score
Standard Deviation 6.33
|
60.74 T-Score
Standard Deviation 6.80
|
|
Mean Change in Patient-reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b) Total Score From Baseline to Week 12
Change from Baseline week 12
|
-10.55 T-Score
Standard Deviation 8.20
|
-4.06 T-Score
Standard Deviation 7.35
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: FAS
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: VMS, psychosocial functioning, physical functioning, and sexual functioning. For each item, the participant indicates if they have experienced the symptom (yes/no). If participants select yes, participants 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. For a MENQOL total score, the aggregated mean of the mean domain scores is calculated.
Outcome measures
| Measure |
Elinzanetant (BAY3427080)
n=316 Participants
Participants received 120 mg elinzanetant orally once daily for 52 weeks
|
Placebo - Elinzanetant (BAY3427080)
n=158 Participants
Participants received placebo orally once daily for the first 12 weeks. 120 mg elinzanetant was administered from Week 13 to 52.
|
|---|---|---|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12
Baseline
|
4.82 Scores on a scale
Standard Deviation 1.17
|
4.77 Scores on a scale
Standard Deviation 1.25
|
|
Mean Change in Menopause Specific Quality of Life Scale (MENQOL) Total Score From Baseline to Week 12
Change from Baseline week 12
|
-1.30 Scores on a scale
Standard Deviation 1.11
|
-0.53 Scores on a scale
Standard Deviation 1.15
|
Adverse Events
Elinzanetant 120mg Week 1-12
Serious events: 8 serious events
Other events: 145 other events
Deaths: 0 deaths
Placebo Week 1-12
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Elinzanetant 120mg Week 13-26
Serious events: 8 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo - Elinzanetant 120mg Week 13-26
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Elinzanetant 120mg Week 1-26
Serious events: 18 serious events
Other events: 211 other events
Deaths: 0 deaths
Elinzanetant 120mg Week 27-52
Serious events: 18 serious events
Other events: 73 other events
Deaths: 0 deaths
Elinzanetant 120mg Week 1-52
Serious events: 33 serious events
Other events: 241 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Elinzanetant 120mg Week 1-12
n=315 participants at risk
Participants who received elinzanetant 120 mg during Weeks 1-12. Only AEs that were reported during Weeks 1-12 are included in the safety tables.
|
Placebo Week 1-12
n=158 participants at risk
Participants who received placebo during Weeks 1-12. Only AEs that were reported during Weeks 1-12 are included in the safety tables.
|
Elinzanetant 120mg Week 13-26
n=294 participants at risk
Participants who received elinzanetant 120 mg during Week 1-12 and continued elinzanetant 120 mg after Week 12. Only AEs that were reported during Weeks 13-26 are included.
|
Placebo - Elinzanetant 120mg Week 13-26
n=150 participants at risk
Participants who received placebo during Weeks 1-12 and switched to elinzanetant 120 mg after Week 12. Only AEs that were reported during Weeks 13-26 are included.
|
Elinzanetant 120mg Week 1-26
n=465 participants at risk
Participants who received elinzanetant 120 mg during Weeks 1-26 (including those who switched from placebo to elinzanetant 120 mg at Week 13). AEs that were reported during placebo period (Weeks 1-12) are excluded.
|
Elinzanetant 120mg Week 27-52
n=409 participants at risk
Participants who received elinzanetant 120 mg during Weeks 27-52. Only AEs that were reported during Weeks 27-52 are included.
|
Elinzanetant 120mg Week 1-52
n=465 participants at risk
Participants who received elinzanetant 120 mg at any time during the study (including those who switched from placebo to elinzanetant 120 mg at Week 13). AEs that were reported during placebo period (Weeks 1-12) are excluded.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Eye disorders
Cataract
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.67%
1/150 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
Infection
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.67%
1/150 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Investigations
Hepatic enzyme increased
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.67%
1/150 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.67%
1/150 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.43%
2/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.43%
2/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Nervous system disorders
Tremor
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Anisomastia
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Endometrial hyperplasia with cellular atypia
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.49%
2/409 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
0.43%
2/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
|
Surgical and medical procedures
Breast reconstruction
|
0.32%
1/315 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/158 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.22%
1/465 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.43%
2/465 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
|
Surgical and medical procedures
Ligament operation
|
0.00%
0/315 • From signing the ICF through study complition, approximately 14 months
|
0.63%
1/158 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/294 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/409 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/465 • From signing the ICF through study complition, approximately 14 months
|
Other adverse events
| Measure |
Elinzanetant 120mg Week 1-12
n=315 participants at risk
Participants who received elinzanetant 120 mg during Weeks 1-12. Only AEs that were reported during Weeks 1-12 are included in the safety tables.
|
Placebo Week 1-12
n=158 participants at risk
Participants who received placebo during Weeks 1-12. Only AEs that were reported during Weeks 1-12 are included in the safety tables.
|
Elinzanetant 120mg Week 13-26
n=294 participants at risk
Participants who received elinzanetant 120 mg during Week 1-12 and continued elinzanetant 120 mg after Week 12. Only AEs that were reported during Weeks 13-26 are included.
|
Placebo - Elinzanetant 120mg Week 13-26
n=150 participants at risk
Participants who received placebo during Weeks 1-12 and switched to elinzanetant 120 mg after Week 12. Only AEs that were reported during Weeks 13-26 are included.
|
Elinzanetant 120mg Week 1-26
n=465 participants at risk
Participants who received elinzanetant 120 mg during Weeks 1-26 (including those who switched from placebo to elinzanetant 120 mg at Week 13). AEs that were reported during placebo period (Weeks 1-12) are excluded.
|
Elinzanetant 120mg Week 27-52
n=409 participants at risk
Participants who received elinzanetant 120 mg during Weeks 27-52. Only AEs that were reported during Weeks 27-52 are included.
|
Elinzanetant 120mg Week 1-52
n=465 participants at risk
Participants who received elinzanetant 120 mg at any time during the study (including those who switched from placebo to elinzanetant 120 mg at Week 13). AEs that were reported during placebo period (Weeks 1-12) are excluded.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
16/315 • Number of events 19 • From signing the ICF through study complition, approximately 14 months
|
1.9%
3/158 • Number of events 3 • From signing the ICF through study complition, approximately 14 months
|
2.0%
6/294 • Number of events 6 • From signing the ICF through study complition, approximately 14 months
|
2.7%
4/150 • Number of events 4 • From signing the ICF through study complition, approximately 14 months
|
5.4%
25/465 • Number of events 29 • From signing the ICF through study complition, approximately 14 months
|
1.7%
7/409 • Number of events 7 • From signing the ICF through study complition, approximately 14 months
|
6.9%
32/465 • Number of events 36 • From signing the ICF through study complition, approximately 14 months
|
|
Gastrointestinal disorders
Nausea
|
6.0%
19/315 • Number of events 20 • From signing the ICF through study complition, approximately 14 months
|
6.3%
10/158 • Number of events 12 • From signing the ICF through study complition, approximately 14 months
|
2.0%
6/294 • Number of events 6 • From signing the ICF through study complition, approximately 14 months
|
3.3%
5/150 • Number of events 7 • From signing the ICF through study complition, approximately 14 months
|
6.0%
28/465 • Number of events 33 • From signing the ICF through study complition, approximately 14 months
|
0.73%
3/409 • Number of events 3 • From signing the ICF through study complition, approximately 14 months
|
6.2%
29/465 • Number of events 36 • From signing the ICF through study complition, approximately 14 months
|
|
General disorders
Asthenia
|
4.1%
13/315 • Number of events 14 • From signing the ICF through study complition, approximately 14 months
|
1.3%
2/158 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
2.4%
7/294 • Number of events 7 • From signing the ICF through study complition, approximately 14 months
|
2.0%
3/150 • Number of events 3 • From signing the ICF through study complition, approximately 14 months
|
4.7%
22/465 • Number of events 24 • From signing the ICF through study complition, approximately 14 months
|
1.2%
5/409 • Number of events 5 • From signing the ICF through study complition, approximately 14 months
|
5.6%
26/465 • Number of events 30 • From signing the ICF through study complition, approximately 14 months
|
|
General disorders
Fatigue
|
9.5%
30/315 • Number of events 37 • From signing the ICF through study complition, approximately 14 months
|
5.1%
8/158 • Number of events 10 • From signing the ICF through study complition, approximately 14 months
|
2.4%
7/294 • Number of events 7 • From signing the ICF through study complition, approximately 14 months
|
3.3%
5/150 • Number of events 7 • From signing the ICF through study complition, approximately 14 months
|
8.8%
41/465 • Number of events 51 • From signing the ICF through study complition, approximately 14 months
|
0.73%
3/409 • Number of events 3 • From signing the ICF through study complition, approximately 14 months
|
9.2%
43/465 • Number of events 57 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
COVID-19
|
1.3%
4/315 • Number of events 4 • From signing the ICF through study complition, approximately 14 months
|
2.5%
4/158 • Number of events 4 • From signing the ICF through study complition, approximately 14 months
|
3.1%
9/294 • Number of events 9 • From signing the ICF through study complition, approximately 14 months
|
2.7%
4/150 • Number of events 6 • From signing the ICF through study complition, approximately 14 months
|
3.7%
17/465 • Number of events 19 • From signing the ICF through study complition, approximately 14 months
|
3.2%
13/409 • Number of events 13 • From signing the ICF through study complition, approximately 14 months
|
6.9%
32/465 • Number of events 34 • From signing the ICF through study complition, approximately 14 months
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
12/315 • Number of events 13 • From signing the ICF through study complition, approximately 14 months
|
3.2%
5/158 • Number of events 5 • From signing the ICF through study complition, approximately 14 months
|
3.1%
9/294 • Number of events 10 • From signing the ICF through study complition, approximately 14 months
|
5.3%
8/150 • Number of events 8 • From signing the ICF through study complition, approximately 14 months
|
6.0%
28/465 • Number of events 31 • From signing the ICF through study complition, approximately 14 months
|
2.2%
9/409 • Number of events 10 • From signing the ICF through study complition, approximately 14 months
|
8.0%
37/465 • Number of events 41 • From signing the ICF through study complition, approximately 14 months
|
|
Investigations
Depression rating scale score increased
|
6.7%
21/315 • Number of events 21 • From signing the ICF through study complition, approximately 14 months
|
8.2%
13/158 • Number of events 14 • From signing the ICF through study complition, approximately 14 months
|
0.34%
1/294 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
0.00%
0/150 • From signing the ICF through study complition, approximately 14 months
|
4.7%
22/465 • Number of events 22 • From signing the ICF through study complition, approximately 14 months
|
0.49%
2/409 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
5.6%
26/465 • Number of events 26 • From signing the ICF through study complition, approximately 14 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
20/315 • Number of events 22 • From signing the ICF through study complition, approximately 14 months
|
6.3%
10/158 • Number of events 10 • From signing the ICF through study complition, approximately 14 months
|
6.5%
19/294 • Number of events 21 • From signing the ICF through study complition, approximately 14 months
|
4.0%
6/150 • Number of events 6 • From signing the ICF through study complition, approximately 14 months
|
9.0%
42/465 • Number of events 49 • From signing the ICF through study complition, approximately 14 months
|
3.7%
15/409 • Number of events 15 • From signing the ICF through study complition, approximately 14 months
|
11.2%
52/465 • Number of events 65 • From signing the ICF through study complition, approximately 14 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
10/315 • Number of events 10 • From signing the ICF through study complition, approximately 14 months
|
4.4%
7/158 • Number of events 10 • From signing the ICF through study complition, approximately 14 months
|
1.7%
5/294 • Number of events 5 • From signing the ICF through study complition, approximately 14 months
|
1.3%
2/150 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
3.4%
16/465 • Number of events 17 • From signing the ICF through study complition, approximately 14 months
|
3.4%
14/409 • Number of events 14 • From signing the ICF through study complition, approximately 14 months
|
6.2%
29/465 • Number of events 31 • From signing the ICF through study complition, approximately 14 months
|
|
Nervous system disorders
Headache
|
9.5%
30/315 • Number of events 42 • From signing the ICF through study complition, approximately 14 months
|
12.7%
20/158 • Number of events 24 • From signing the ICF through study complition, approximately 14 months
|
4.4%
13/294 • Number of events 17 • From signing the ICF through study complition, approximately 14 months
|
4.7%
7/150 • Number of events 8 • From signing the ICF through study complition, approximately 14 months
|
10.3%
48/465 • Number of events 67 • From signing the ICF through study complition, approximately 14 months
|
2.7%
11/409 • Number of events 16 • From signing the ICF through study complition, approximately 14 months
|
12.0%
56/465 • Number of events 85 • From signing the ICF through study complition, approximately 14 months
|
|
Nervous system disorders
Somnolence
|
10.8%
34/315 • Number of events 37 • From signing the ICF through study complition, approximately 14 months
|
3.8%
6/158 • Number of events 6 • From signing the ICF through study complition, approximately 14 months
|
1.4%
4/294 • Number of events 4 • From signing the ICF through study complition, approximately 14 months
|
3.3%
5/150 • Number of events 5 • From signing the ICF through study complition, approximately 14 months
|
9.0%
42/465 • Number of events 46 • From signing the ICF through study complition, approximately 14 months
|
0.24%
1/409 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
9.0%
42/465 • Number of events 47 • From signing the ICF through study complition, approximately 14 months
|
|
Psychiatric disorders
Depression
|
4.4%
14/315 • Number of events 14 • From signing the ICF through study complition, approximately 14 months
|
0.63%
1/158 • Number of events 1 • From signing the ICF through study complition, approximately 14 months
|
2.4%
7/294 • Number of events 7 • From signing the ICF through study complition, approximately 14 months
|
1.3%
2/150 • Number of events 2 • From signing the ICF through study complition, approximately 14 months
|
4.9%
23/465 • Number of events 23 • From signing the ICF through study complition, approximately 14 months
|
1.2%
5/409 • Number of events 5 • From signing the ICF through study complition, approximately 14 months
|
6.0%
28/465 • Number of events 29 • From signing the ICF through study complition, approximately 14 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60