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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis

    Summary
    EudraCT number
    		 2021-001229-26
    Trial protocol
    		 IT   ES   DE  
    Global end of trial date
    03 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Feb 2025
    First version publication date
    28 Feb 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ALXN2050-MG-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05218096
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals, Inc.
    Sponsor organisation address
    121 Seaport Boulevard, Boston, MA, United States, 02210
    Public contact
    European Clinical Trial Information, Alexion Pharmaceuticals, Inc., +35 3874162507, clinicaltrials.eu@alexion.com
    Scientific contact
    European Clinical Trial Information, Alexion Pharmaceuticals, Inc., +35 3874162507, clinicaltrials.eu@alexion.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
    Interim
    Date of interim/final analysis
    30 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study will evaluate the efficacy and safety of ALXN2050 (120 milligrams [mg], 180 mg) in participants with generalized myasthenia gravis (gMG). Safety will be monitored throughout the study.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and with the following: Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines; Applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines; Applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Apr 2022
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Serbia: 9
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    United States: 18
    Worldwide total number of subjects
    70
    EEA total number of subjects
    33
    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)
    50
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study did not meet its primary efficacy end point and was early terminated by the Sponsor.

    Pre-assignment
    Screening details
    		 All study drugs (ALXN2050, placebo) were administered twice daily (BID).

    Period 1
    Period 1 title
    Primary Evaluation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Subject
    Blinding implementation details
    Masking of treatment allocation will be observed until at least Week 34.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: ALXN2050 180 mg BID
    Arm description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 2: ALXN2050 120 mg BID
    Arm description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 3: Placebo
    Arm description
    		 Participants received placebo BID during the primary evaluation period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo orally.

    Number of subjects in period 1
    		Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3: Placebo
    Started
    28
    14
    28
    Received at Least 1 Dose of Study Drug
    28
    14
    28
    Entered Extended Treatment Period
    27
    14
    26
    Re-randomized to ALXN2050 120 mg BID
    0 [1]
    0 [2]
    13 [3]
    Re-randomized to ALXN2050 180 mg BID
    0 [4]
    0 [5]
    13 [6]
    Completed
    27
    14
    26
    Not completed
    1
    0
    2
         Physician decision
    1
    -
    -
         Consent withdrawn by subject
    -
    -
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone applies only to participants in Group 3: Placebo.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone applies only to participants in Group 3: Placebo.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants in this arm who completed the Primary Evaluation period were re-randomized to Group 3A: Placebo/ALXN2050 180 mg BID.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone applies only to participants in Group 3: Placebo.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This milestone applies only to participants in Group 3: Placebo.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants in this arm who completed the Primary Evaluation period were re-randomized to Group 3A: Placebo/ALXN2050 120 mg BID.
    Period 2
    Period 2 title
    Extended Treatment (Ext Treat)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    Masking of treatment allocation will be observed until at least Week 34.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: ALXN2050 180 mg BID
    Arm description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 2: ALXN2050 120 mg BID
    Arm description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 3a: Placebo/ALXN2050 180 mg BID
    Arm description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo orally.

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 3b: Placebo/ALXN2050 120 mg BID
    Arm description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo orally.

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Number of subjects in period 2
    		Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3a: Placebo/ALXN2050 180 mg BID Group 3b: Placebo/ALXN2050 120 mg BID
    Started
    27
    14
    13
    13
    Received at Least 1 Dose of Study Drug
    27
    14
    13
    13
    Entered Open-label Extension Period
    16
    6
    8
    9
    Completed
    16
    6
    8
    9
    Not completed
    11
    8
    5
    4
         Clinical Deterioration
    1
    1
    -
    -
         Consent withdrawn by subject
    1
    3
    2
    2
         Physician decision
    -
    1
    -
    -
         Study Terminated by Sponsor
    6
    3
    3
    2
         Lack of efficacy
    3
    -
    -
    -
    Period 3
    Period 3 title
    Open-label Extension (OLE)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    Masking of treatment allocation will be observed until at least Week 34.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: ALXN2050 180 mg BID
    Arm description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 2: ALXN2050 120 mg BID
    Arm description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 3a: Placebo/ALXN2050 180 mg BID
    Arm description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo orally.

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Arm title
    		 Group 3b: Placebo/ALXN2050 120 mg BID
    Arm description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo orally.

    Investigational medicinal product name
    ALXN2050
    Investigational medicinal product code
    Other name
    ACH-0145228 (formerly)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ALXN2050 orally.

    Number of subjects in period 3
    		Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3a: Placebo/ALXN2050 180 mg BID Group 3b: Placebo/ALXN2050 120 mg BID
    Started
    16
    6
    8
    9
    Received at Least 1 Dose of Study Drug
    16
    6
    8
    9
    Completed
    0
    0
    0
    0
    Not completed
    16
    6
    8
    9
         Adverse event, serious fatal
    -
    -
    1
    -
         Adverse event, non-fatal
    1
    -
    -
    1
         Pregnancy
    -
    -
    -
    1
         Study Terminated by Sponsor
    13
    4
    7
    7
         Lost to follow-up
    1
    -
    -
    -
         Lack of efficacy
    1
    2
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1: ALXN2050 180 mg BID
    Reporting group description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 2: ALXN2050 120 mg BID
    Reporting group description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 3: Placebo
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period.

    Reporting group values
    		 Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3: Placebo Total
    Number of subjects
    		 28 14 28 70
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.0 ( 15.55 ) 55.9 ( 13.02 ) 58.2 ( 16.45 ) -
    Sex: Female, Male
    Units:
        Female
    		 18 10 10 38
        Male
    		 10 4 18 32
    Ethnicity (NIH/OMB)
    National Institutes of Health/Office of Management & Budget (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 1 1 6
        Not Hispanic or Latino
    		 24 13 26 63
        Unknown or Not Reported
    		 0 0 1 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 4 1 7
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 26 10 27 63
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Baseline MG-ADL Total Score
    Myasthenia Gravis Activities of Daily Living (MG-ADL)
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 9.4 ( 2.23 ) 9.0 ( 2.96 ) 8.8 ( 1.75 ) -

    End points

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    End points reporting groups
    Reporting group title
    Group 1: ALXN2050 180 mg BID
    Reporting group description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 2: ALXN2050 120 mg BID
    Reporting group description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 3: Placebo
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period.
    Reporting group title
    Group 1: ALXN2050 180 mg BID
    Reporting group description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 2: ALXN2050 120 mg BID
    Reporting group description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 3a: Placebo/ALXN2050 180 mg BID
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.

    Reporting group title
    Group 3b: Placebo/ALXN2050 120 mg BID
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.
    Reporting group title
    Group 1: ALXN2050 180 mg BID
    Reporting group description
    		 Participants received 180 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 2: ALXN2050 120 mg BID
    Reporting group description
    		 Participants received 120 mg ALXN2050 BID during all 3 study periods (primary evaluation, extended treatment, open-label extension).

    Reporting group title
    Group 3a: Placebo/ALXN2050 180 mg BID
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.

    Reporting group title
    Group 3b: Placebo/ALXN2050 120 mg BID
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.

    Primary: Percentage Of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction Of ≥ 2 Points In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy

    		 Close Top of page
    End point title
    		 Percentage Of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction Of ≥ 2 Points In Any 4 Consecutive Weeks During The First 8 Weeks And Who Did Not Receive Rescue Therapy
    End point description
    The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function.
    End point type
    Primary
    End point timeframe
    Baseline through Week 8
    End point values
    		 Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3: Placebo
    Number of subjects analysed
    16
    8
    18
    Units: percentage of participants
        number (confidence interval 90%)
    57.1 (40.0 to 73.1)
    57.1 (32.5 to 79.4)
    64.3 (47.0 to 79.2)
    Statistical analysis title
    		 Group 2: ALXN2050 120 mg BID, Group 3: Placebo
    Comparison groups
    Group 2: ALXN2050 120 mg BID v Group 3: Placebo
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.7341
    Method
    		 Barnard's Unconditional Exact Test
    Parameter type
    		 Difference
    Point estimate
    -7.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -34.8
         upper limit
    		 19.3
    Notes
    [1] - Difference
    Statistical analysis title
    		 Group 1: ALXN2050 180 mg BID, Group 3: Placebo
    Comparison groups
    Group 1: ALXN2050 180 mg BID v Group 3: Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.6797
    Method
    		 Barnard's Unconditional Exact Test
    Parameter type
    		 Difference
    Point estimate
    -7.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -28.8
         upper limit
    		 15
    Notes
    [2] - Difference

    Secondary: Change From Baseline In Quantitative Myasthenia Gravis (QMG) Total Score At Week 8

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    End point title
    		 Change From Baseline In Quantitative Myasthenia Gravis (QMG) Total Score At Week 8
    End point description
    The QMG Score for Disease Severity is an objective evaluation of therapy for MG and is based on quantitative testing of sentinel muscle groups. The QMG instrument consists of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The QMG total score was calculated as the sum of the scores of the 13 items and ranges from 0 to 39, with higher scores indicating more severe disease. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline QMG total score as a covariate were used to calculate the least square (LS) mean and the standard error.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    		 Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3: Placebo
    Number of subjects analysed
    28
    13
    27
    Units: units on a scale
        least squares mean (standard error)
    -1.1 ( 0.67 )
    -3.0 ( 0.98 )
    -1.4 ( 0.68 )
    No statistical analyses for this end point

    Secondary: Change From Baseline In MG-ADL Total Score At Week 8

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    End point title
    		 Change From Baseline In MG-ADL Total Score At Week 8
    End point description
    The MG-ADL profile is an 8-item participant-reported scale that focuses on relevant symptoms and functional performance of ADL in participants with MG. The 8 items of the MG-ADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects of MG. Each response is graded 0 (normal) to 3 (most severe). The MG-ADL total score was calculated as the sum of the scores of the 8 items and ranges from 0 to 24, with higher scores indicating worse function. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline MG-ADL total score as a covariate were used to calculate the LS mean and the standard error.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    		 Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3: Placebo
    Number of subjects analysed
    27
    14
    26
    Units: units on a scale
        least squares mean (standard error)
    -2.5 ( 0.50 )
    -3.7 ( 0.70 )
    -3.2 ( 0.51 )
    No statistical analyses for this end point

    Secondary: Change From Baseline In Quality Of Life In Neurological Disorders (Neuro-QoL) Fatigue Score At Week 8

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    End point title
    		 Change From Baseline In Quality Of Life In Neurological Disorders (Neuro-QoL) Fatigue Score At Week 8
    End point description
    The Neuro-QoL Fatigue questionnaire is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each item is scored on a scale of 1–5, with 1 indicating "never" and 5 indicating "sometimes". The Neuro-QoL Fatigue score was calculated as the sum of the scores of the 19 items and ranges from 19–95, with higher scores indicating greater fatigue and greater impact of MG on activities. Baseline score at each timepoint as the response variable, treatment group, study visit, and treatment-by-study visit interaction as fixed categorical effects, and baseline Neuro-QoL Fatigue score as a covariate were used to calculate the LS mean and the standard error.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 8
    End point values
    		 Group 1: ALXN2050 180 mg BID Group 2: ALXN2050 120 mg BID Group 3: Placebo
    Number of subjects analysed
    28
    13
    27
    Units: units on a scale
        least squares mean (standard error)
    -8.7 ( 2.65 )
    -10.1 ( 3.77 )
    -8.3 ( 2.73 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Day 1) up to 30 days after last dose of study intervention (approximately 2 years).
    Adverse event reporting additional description
    Safety Set: all randomized participants who received at least 1 dose of study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Group 1: ALXN2050 180 mg BID (Primary Evaluation)
    Reporting group description
    		 Participants received 180 mg ALXN2050 BID during the primary evaluation period.

    Reporting group title
    Group 3: Placebo (Primary Evaluation)
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period.

    Reporting group title
    Group 3b: Placebo/ALXN2050 120 mg BID (Ext Treat & OLE)
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 120 mg BID during the extended treatment period and the open-label extension period.

    Reporting group title
    Group 2: ALXN2050 120 mg BID (Ext Treat & OLE)
    Reporting group description
    		 Participants received 120 mg ALXN2050 BID during the extended treatment period and open-label extension period.

    Reporting group title
    Group 3a: Placebo/ALXN2050 180 mg BID (Ext Treat & OLE)
    Reporting group description
    		 Participants received placebo BID during the primary evaluation period, followed by ALXN2050 180 mg BID during the extended treatment period and the open-label extension period.

    Reporting group title
    Group 2: ALXN2050 120 mg BID (Primary Evaluation)
    Reporting group description
    		 Participants received 120 mg ALXN2050 BID during the primary evaluation period.

    Reporting group title
    Group 1: ALXN2050 180 mg BID (Ext Treat & OLE)
    Reporting group description
    		 Participants received 180 mg ALXN2050 BID during the extended treatment period and open-label extension period.

    Serious adverse events
    		 Group 1: ALXN2050 180 mg BID (Primary Evaluation) Group 3: Placebo (Primary Evaluation) Group 3b: Placebo/ALXN2050 120 mg BID (Ext Treat & OLE) Group 2: ALXN2050 120 mg BID (Ext Treat & OLE) Group 3a: Placebo/ALXN2050 180 mg BID (Ext Treat & OLE) Group 2: ALXN2050 120 mg BID (Primary Evaluation) Group 1: ALXN2050 180 mg BID (Ext Treat & OLE)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 28 (10.71%)
    2 / 13 (15.38%)
    4 / 14 (28.57%)
    3 / 13 (23.08%)
    1 / 14 (7.14%)
    4 / 27 (14.81%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
    Additional description: Adverse event only affected female participants.
         subjects affected / exposed [1]
    0 / 18 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Psychiatric disorders
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex meningitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Salmonella sepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Adverse events affected only female participants.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: ALXN2050 180 mg BID (Primary Evaluation) Group 3: Placebo (Primary Evaluation) Group 3b: Placebo/ALXN2050 120 mg BID (Ext Treat & OLE) Group 2: ALXN2050 120 mg BID (Ext Treat & OLE) Group 3a: Placebo/ALXN2050 180 mg BID (Ext Treat & OLE) Group 2: ALXN2050 120 mg BID (Primary Evaluation) Group 1: ALXN2050 180 mg BID (Ext Treat & OLE)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 28 (60.71%)
    15 / 28 (53.57%)
    10 / 13 (76.92%)
    7 / 14 (50.00%)
    9 / 13 (69.23%)
    7 / 14 (50.00%)
    17 / 27 (62.96%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Spider vein
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Facial discomfort
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    Vaccination site erythema
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Cervical dysplasia
    Additional description: Adverse events affected only female participants.
         subjects affected / exposed [2]
    0 / 18 (0.00%)
    0 / 10 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 5 (0.00%)
    0 / 10 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Benign prostatic hyperplasia
    Additional description: Adverse events affected only male participants.
         subjects affected / exposed [3]
    0 / 10 (0.00%)
    0 / 18 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    Cough
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Fall
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Demyelination
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Headache
         subjects affected / exposed
    8 / 28 (28.57%)
    5 / 28 (17.86%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    12
    6
    1
    1
    0
    0
    5
    Sensory disturbance
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    Syncope
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Macrocytosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Spontaneous haematoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Neutrophilia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Microcytic anaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    5 / 28 (17.86%)
    1 / 28 (3.57%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    2 / 27 (7.41%)
         occurrences all number
    5
    1
    1
    2
    0
    1
    2
    Constipation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Nausea
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    3
    0
    1
    0
    0
    1
    1
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Renal colic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Ketonuria
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Endocrine disorders
    Thyroid cyst
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Spinal stenosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    1
    Limb discomfort
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 13 (0.00%)
    2 / 14 (14.29%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    2
    COVID-19
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 28 (3.57%)
    2 / 13 (15.38%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    2
    1
    1
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 28 (10.71%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 13 (15.38%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    3
    0
    0
    3
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    5 / 27 (18.52%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    6
    Urinary tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 13 (7.69%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    1
    2
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 14 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 13 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 14 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Adverse events affected only female participants.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Adverse events affected only male participants.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2021
    Updated the list of exclusion criteria with a renal impairment criterion and indicated that medications known to significantly prolong the corrected QT interval were not allowed during the study.
    09 Mar 2023
    Addressed the requirements for conducting a clinical study under the EU Clinical Trials Register (EU CTR).
    15 Nov 2023
    Addressed the requirements for transitioning a clinical study under the EU CTR.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study did not meet its primary efficacy end point and was early terminated by the Sponsor.
    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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