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    Clinical Trial Results:
    A randomized, double-blind, open for active comparator, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of three different doses of P2X3 antagonist (BAY 1817080) versus placebo and elagolix 150 mg in women with symptomatic endometriosis

    Summary
    EudraCT number
    		 2020-003131-16
    Trial protocol
    		 DE   CZ   SK   FI   NO   AT   LT   PL   BE   BG   HU   GR   EE   LV   IT  
    Global end of trial date
    03 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2023
    First version publication date
    09 May 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20584
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04614246
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, 51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the dose-response relationship and demonstrate efficacy of eliapixant compared to placebo in women with symptomatic endometriosis.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 1. A placebo-controlled design was considered scientifically necessary to differentiate drug effects from the natural course of the disease and placebo effects. 2. Elagolix 150 mg once daily is approved for the treatment of the disease and was given as an active comparator open-label.
    Actual start date of recruitment
    29 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Bulgaria: 8
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    Czechia: 26
    Country: Number of subjects enrolled
    Finland: 1
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Japan: 42
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 39
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    215
    EEA total number of subjects
    137
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    215
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multinational study was conducted between 29 JAN 2021 First Patient First Visit (FPFV) and 03 MAY 2022 Last Patient Last Visit (LPLV) in 20 countries/regions: Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Finland , Germany, Greece, Hungary, Italy, Japan, Lithuania, Latvia, Norway, Poland, Slovakia, Spain, United States

    Pre-assignment
    Screening details
    		 Participant disposition was generally well balanced between the treatment arms. 504 participants were enrolled with 289 participants failed screening or were not assigned to treatment. A total of 215 participants were randomized to 5 treatment arms (44 to eliapixant, 44 to eliapixant, 43 to eliapixant, 43 to placebo, and 41 to Elagolix).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eliapixant (BAY1817080) 25 mg
    Arm description
    		 25mg eliapixant twice daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25mg eliapixant twice daily for 12 weeks

    Arm title
    		 Eliapixant (BAY1817080) 75 mg
    Arm description
    		 75mg eliapixant twice daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75mg eliapixant twice daily for 12 weeks

    Arm title
    		 Eliapixant (BAY1817080) 150 mg
    Arm description
    		 150mg eliapixant twice daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eliapixant
    Investigational medicinal product code
    BAY1817080
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150mg eliapixant twice daily for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo for eliapixant twice daily for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo for eliapixant twice daily for 12 weeks

    Arm title
    		 Elagolix 150mg
    Arm description
    		 150mg Elagolix once daily for 12 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elagolix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150mg Elagolix once daily for 12 weeks

    Number of subjects in period 1
    		Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo Elagolix 150mg
    Started
    44
    44
    43
    43
    41
    Completed
    28
    22
    22
    24
    24
    Not completed
    16
    22
    21
    19
    17
         Consent withdrawn by subject
    4
    2
    4
    3
    4
         Physician decision
    -
    2
    1
    -
    -
         Adverse event, non-fatal
    -
    1
    1
    2
    1
         Pregnancy
    2
    -
    1
    -
    -
         Study terminated by sponsor
    -
    15
    12
    13
    9
         Other reason
    -
    1
    2
    -
    -
         Lost to follow-up
    -
    1
    -
    1
    3
         Excluded by sponsor due to safety reasons
    10
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eliapixant (BAY1817080) 25 mg
    Reporting group description
    		 25mg eliapixant twice daily for 12 weeks

    Reporting group title
    Eliapixant (BAY1817080) 75 mg
    Reporting group description
    		 75mg eliapixant twice daily for 12 weeks

    Reporting group title
    Eliapixant (BAY1817080) 150 mg
    Reporting group description
    		 150mg eliapixant twice daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for eliapixant twice daily for 12 weeks

    Reporting group title
    Elagolix 150mg
    Reporting group description
    		 150mg Elagolix once daily for 12 weeks

    Reporting group values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo Elagolix 150mg Total
    Number of subjects
    		 44 44 43 43 41 215
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0 0 0 0
        Between 18 and 65 years
    		 44 44 43 43 41 215
        >=65 years
    		 0 0 0 0 0 0
    Sex: Female, Male
    Units: Participants
        Female
    		 44 44 43 43 41 215
        Male
    		 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Eliapixant (BAY1817080) 25 mg
    Reporting group description
    		 25mg eliapixant twice daily for 12 weeks

    Reporting group title
    Eliapixant (BAY1817080) 75 mg
    Reporting group description
    		 75mg eliapixant twice daily for 12 weeks

    Reporting group title
    Eliapixant (BAY1817080) 150 mg
    Reporting group description
    		 150mg eliapixant twice daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for eliapixant twice daily for 12 weeks

    Reporting group title
    Elagolix 150mg
    Reporting group description
    		 150mg Elagolix once daily for 12 weeks

    Primary: Absolute change in mean worst EAPP from baseline to week 12 - pPPS

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    End point title
    		 Absolute change in mean worst EAPP from baseline to week 12 - pPPS [1] [2]
    End point description
    The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Primary
    End point timeframe
    from baseline to week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is given as an add-on endpoint to the primary endpoint, because the statistics on changes between different time points within one arm cannot be correctly displayed in the "Statistical Analysis Section", due to database constraints.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Active comparator Elagolix not part of Primary per protocol set (pPPS)
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo
    Number of subjects analysed
    31
    31
    31
    30
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    6.40 ± 1.66
    6.13 ± 1.77
    6.95 ± 1.38
    6.14 ± 1.96
        Week 12
    4.57 ± 2.10
    4.15 ± 2.49
    5.15 ± 2.42
    4.29 ± 1.71
        Week 12: Change from Baseline
    -1.56 ± 1.35
    -2.12 ± 2.66
    -1.88 ± 2.03
    -1.89 ± 1.91
    No statistical analyses for this end point

    Primary: Absolute change in mean worst EAPP from baseline to week 12 - pPPS: Mean (SE)

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    End point title
    		 Absolute change in mean worst EAPP from baseline to week 12 - pPPS: Mean (SE) [3] [4]
    End point description
    Least square-mean of change obtained by mixed model repeated measures (MMRM) from baseline to Week 12 (End of intervention) in the pPPS. The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Primary
    End point timeframe
    change from baseline to week 12
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is given as an add-on endpoint to the primary endpoint, because the statistics on changes between different time points within one arm cannot be correctly displayed in the "Statistical Analysis Section", due to database constraints.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Active comparator Elagolix not part of Primary per protocol set (pPPS)
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo
    Number of subjects analysed
    31
    31
    31
    30
    Units: units on a scale
    least squares mean (standard error)
        week 12
    -1.63 ± 0.38
    -2.13 ± 0.41
    -1.96 ± 0.41
    -1.94 ± 0.38
    No statistical analyses for this end point

    Primary: Absolute change in mean worst EAPP from baseline to week 12 - pPPS: 80% confidence interval (CI)

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    End point title
    		 Absolute change in mean worst EAPP from baseline to week 12 - pPPS: 80% confidence interval (CI) [5] [6]
    End point description
    Least square-mean (LS-mean, Confidence Interval) of change obtained by mixed model repeated measures (MMRM) from baseline to Week 12 (End of intervention) in the pPPS. The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Primary
    End point timeframe
    change from baseline to week 12
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis is given as an add-on endpoint to the primary endpoint, because the statistics on changes between different time points within one arm cannot be correctly displayed in the "Statistical Analysis Section", due to database constraints.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Active comparator Elagolix not part of Primary per protocol set (pPPS)
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo
    Number of subjects analysed
    31
    31
    31
    30
    Units: units on a scale
    least squares mean (confidence interval 80%)
        week 12
    -1.63 (-2.13 to -1.14)
    -2.13 (-2.66 to -1.61)
    -1.96 (-2.48 to -1.43)
    -1.94 (-2.44 to -1.45)
    No statistical analyses for this end point

    Secondary: Absolute change in mean worst EAPP from baseline to week 12 - PPS: Mean (SE)

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    End point title
    		 Absolute change in mean worst EAPP from baseline to week 12 - PPS: Mean (SE)
    End point description
    Least square-mean (LS-mean, SD) of change obtained by mixed model repeated measures (MMRM) from baseline to Week 12 (End of intervention) in the PPS, based on descriptive statistics. The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Secondary
    End point timeframe
    up to 12 weeks
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo Elagolix 150mg
    Number of subjects analysed
    31
    31
    31
    30
    37
    Units: units on a scale
    least squares mean (standard error)
        week 12
    -1.60 ± 0.40
    -2.07 ± 0.42
    -1.97 ± 0.42
    -1.89 ± 0.40
    -2.69 ± 0.41
    No statistical analyses for this end point

    Secondary: Difference of least square-mean - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS

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    End point title
    		 Difference of least square-mean - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS [7]
    End point description
    Least square-mean of change (pairwise comparison between treatment arms and placebo arm) obtained by mixed model repeated measures (MMRM) from baseline to Week 12 (End of intervention) in the pPPS. The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Secondary
    End point timeframe
    change from baseline to week 12
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Active comparator Elagolix not part of Primary per protocol set (pPPS)
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg
    Number of subjects analysed
    31
    31
    37
    Units: units on a scale
    least squares mean (standard error)
        12 weeks - treatment vs placebo
    0.29 ± 0.54
    -0.18 ± 0.55
    -0.08 ± 0.56
    No statistical analyses for this end point

    Secondary: Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS

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    End point title
    		 Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS [8]
    End point description
    Least square-mean of change (LS-mean, 95% Confidence Interval, CI); pairwise comparison between treatment arms and placebo arm) obtained by mixed model repeated measures (MMRM) from baseline to Week 12 (End of intervention) in the pPPS. The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Secondary
    End point timeframe
    change from baseline to week 12
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Active comparator Elagolix not part of Primary per protocol set (pPPS)
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg
    Number of subjects analysed
    31
    31
    37
    Units: units on a scale
    least squares mean (confidence interval 95%)
        12 weeks - treatment vs placebo
    0.29 (-0.77 to 1.35)
    -0.18 (-1.27 to 0.91)
    -0.08 (-1.17 to 1.02)
    No statistical analyses for this end point

    Secondary: Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS

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    End point title
    		 Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS [9]
    End point description
    Least square-mean of change (LS-mean, 80% Confidence Interval, CI); pairwise comparison between treatment arms and placebo arm) obtained by mixed model repeated measures (MMRM) from baseline to Week 12 (End of intervention) in the PPS. The worst EAPP was measured daily on the 0-10 Numerical Rating Scale (NRS) by item 1 of the Endometriosis Symptom Diary (ESD). In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The absolute change in mean worst EAPP was from baseline (last 28 days before the first intake of study drug) to end of intervention (last 28 days ending with the last intake of study drug planned on Day 84 [+3]). The time frame of 28 days captures a menstrual cycle on average.
    End point type
    Secondary
    End point timeframe
    change from baseline to week 12
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Active comparator Elagolix not part of Primary per protocol set (pPPS)
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg
    Number of subjects analysed
    31
    31
    37
    Units: units on a scale
    least squares mean (confidence interval 80%)
        12 weeks - treatment vs placebo
    0.29 (-0.40 to 0.98)
    -0.18 (-0.8 to 0.53)
    -0.08 (-0.79 to 0.64)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events

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    End point title
    		 Number of participants with adverse events
    End point description
    A treatment-emergent AE (TEAE) was defined as any event arising or worsening after the start of study drug administration until 14 days after the last study medication intake. BID = twice daily OD = once daily
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 14 days after last study medication intake
    End point values
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg Eliapixant (BAY1817080) 150 mg Placebo Elagolix 150mg
    Number of subjects analysed
    39
    38
    38
    37
    38
    Units: Participants
        Any AE
    33
    28
    32
    30
    32
        Any SAE
    1
    2
    3
    1
    2
        Any AE with outcome death
    0
    0
    0
    0
    0
        Any AE: permanent discontinuation of study drug
    0
    1
    1
    2
    1
        Any TEAE
    23
    21
    29
    27
    28
        Any drug related TEAE
    4
    6
    10
    10
    13
        Any serious TEAE
    0
    2
    2
    1
    1
        Any drug related serious TEAE
    0
    0
    1
    0
    1
        Any TEAE with outcome death
    0
    0
    0
    0
    0
        Any TEAE: permanent discontinuation of studly drug
    0
    1
    1
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Only TEAEs, that were arising or worsening after the start of study drug administration until 14 days after the last study medication intake with an average of 14 weeks, are reported in below adverse events table.
    Adverse event reporting additional description
    While for the all-cause deaths that occurred at any time during the study before the last contact, up to 285 days are reported.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Eliapixant (BAY1817080) 25 mg
    Reporting group description
    		 25 mg Eliapixant twice daily for 12 weeks

    Reporting group title
    Eliapixant (BAY1817080) 75 mg
    Reporting group description
    		 75 mg Eliapixant twice daily for 12 weeks

    Reporting group title
    150 mg Elagolix
    Reporting group description
    		 150 mg Elagolix once daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo for 12 weeks

    Reporting group title
    Eliapixant (BAY1817080) 150 mg
    Reporting group description
    		 75 mg Eliapixant twice daily for 12 weeks

    Serious adverse events
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg 150 mg Elagolix Placebo Eliapixant (BAY1817080) 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    1 / 38 (2.63%)
    1 / 37 (2.70%)
    2 / 38 (5.26%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    Liver function test increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Endometriosis ablation
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Carbuncle
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Eliapixant (BAY1817080) 25 mg Eliapixant (BAY1817080) 75 mg 150 mg Elagolix Placebo Eliapixant (BAY1817080) 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 39 (58.97%)
    20 / 38 (52.63%)
    28 / 38 (73.68%)
    27 / 37 (72.97%)
    29 / 38 (76.32%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vascular disorders
    Varicose vein
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    7 / 38 (18.42%)
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    7
    2
    0
    Hypertension
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypertensive crisis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Discomfort
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    3 / 37 (8.11%)
    2 / 38 (5.26%)
         occurrences all number
    3
    1
    0
    3
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 39 (0.00%)
    4 / 38 (10.53%)
    0 / 38 (0.00%)
    4 / 37 (10.81%)
    0 / 38 (0.00%)
         occurrences all number
    0
    6
    0
    7
    0
    Malaise
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    2
    Chest pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vaccination site swelling
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Immune system disorders
    Immunisation reaction
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    3
    0
    2
    0
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    0
    2
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Adnexa uteri cyst
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Cervix disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Genital haemorrhage
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Oligomenorrhoea
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Panic attack
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Mood altered
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Irritability
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
    5 / 38 (13.16%)
    4 / 37 (10.81%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    6
    4
    2
    Activated partial thromboplastin time abnormal
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 38 (0.00%)
    3 / 38 (7.89%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    3
    0
    3
    1
    0
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    0
    1
    0
    3
    Blood glucose abnormal
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Full blood count abnormal
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Prothrombin time abnormal
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Coronavirus test positive
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Coagulation test abnormal
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    1
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    White blood cell count increased
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Platelet count increased
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Nervous system disorders
    Anosmia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    1
    3
    Headache
         subjects affected / exposed
    7 / 39 (17.95%)
    7 / 38 (18.42%)
    8 / 38 (21.05%)
    9 / 37 (24.32%)
    6 / 38 (15.79%)
         occurrences all number
    15
    11
    15
    17
    9
    Migraine
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    Hypogeusia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    0
    0
    0
    3
    Dizziness
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    1 / 38 (2.63%)
         occurrences all number
    1
    0
    0
    1
    1
    Taste disorder
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    2 / 38 (5.26%)
         occurrences all number
    0
    0
    0
    1
    2
    Somnolence
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    1
    1
    Psychogenic seizure
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Anaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    1
    1
    Leukopenia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    2
    Neutropenia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Bone marrow oedema
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ear swelling
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    3 / 38 (7.89%)
         occurrences all number
    0
    0
    1
    0
    3
    Nausea
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    2 / 38 (5.26%)
    1 / 37 (2.70%)
    5 / 38 (13.16%)
         occurrences all number
    0
    1
    2
    2
    6
    Gastritis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    0
    1
    Angular cheilitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 38 (7.89%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    3
    1
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Eczema
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Bladder pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    0
    1
    1
    Back pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Myalgia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    1
    1
    Laryngitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Carbuncle
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    COVID-19
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 38 (5.26%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    2
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Genital herpes
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vaginal infection
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    2 / 38 (5.26%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    2 / 37 (5.41%)
    3 / 38 (7.89%)
         occurrences all number
    1
    0
    1
    2
    3
    Lice infestation
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    1 / 37 (2.70%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    1
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 38 (0.00%)
    0 / 37 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 38 (10.53%)
    2 / 38 (5.26%)
    2 / 37 (5.41%)
    1 / 38 (2.63%)
         occurrences all number
    1
    4
    3
    2
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Metabolic syndrome
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gout
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 38 (2.63%)
    0 / 37 (0.00%)
    0 / 38 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2021
    • Adapted Visit schedule to allow for testing of liver parameters every 2 weeks during the treatment period as precautionary measure • Adaptation of exclusion criterion 7 with addition of an example for extremely low body weight to support the investigator decisions on participant selection.
    27 Jan 2022
    • Adapted Visit schedule to allow for a comprehensive safety follow up of study participants exposed to eliapixant. • Update on risk of potential changes in liver function laboratory parameters with eliapixant use. • Updated benefit/risk assessment to indicate that the benefit-risk ratio for this study was no longer considered to be positive and a clinical hold with an immediate stop of treatment and enrolment was decided. • Indicating that abnormal laboratory results meeting the criteria of transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) >8x ULN or >3x ULN with total bilirubin >2x ULN should be reported as adverse events of special interest to ensure a comprehensive safety follow up of exposed study participants • Liver imaging was added to the close observation assessments, and hepatitis C virus Ribonucleic acid (HCV-RNA) was added to the parameters for samples to be analyzed for initial close liver observation to ensure a comprehensive safety follow up of exposed study participants

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Jan 2022
    study was stopped due to safety reasons.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study was prematurely terminated due to safety reasons.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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