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    Clinical Trial Results:
    A Phase IIB, Randomized, Double blinded, Placebo controlled, Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction, Persistent Inflammation, and Elevated N terminal Prohormone Brain Natriuretic Peptide

    Summary
    EudraCT number
    		 2020-000840-75
    Trial protocol
    		 HU   CZ   PL   NL   IT  
    Global end of trial date
    09 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Nov 2024
    First version publication date
    24 Nov 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D4920C00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04610892
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AB, 151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.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
    29 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo
    Protection of trial subjects
    The DMC will be responsible for safeguarding the interests of the participants, by assessing the safety of the intervention during the study and for reviewing the overall conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    Czechia: 54
    Country: Number of subjects enrolled
    Hungary: 55
    Country: Number of subjects enrolled
    Italy: 54
    Country: Number of subjects enrolled
    Japan: 32
    Country: Number of subjects enrolled
    Netherlands: 41
    Country: Number of subjects enrolled
    Poland: 40
    Country: Number of subjects enrolled
    Spain: 69
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    United States: 48
    Worldwide total number of subjects
    423
    EEA total number of subjects
    313
    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)
    285
    From 65 to 84 years
    138
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between 4/11/2020 and 08/11/2023 in below countries. Australia Canada Czech Republic Hungary Italy Japan Netherlands Poland Spain United Kingdom United States of America

    Pre-assignment
    Screening details
    		 Subjects who met the inclusion and none of the exclusion criteria were enrolled in the study. All study assessments were performed as per the schedule of assessment.

    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, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MEDI6570 50 mg
    Arm description
    		 Participants received MEDI6570 50 mg every 4 weeks for 32 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI6570
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 1 injection (0.5 mL) of MEDI6570 50 mg every 4 weeks for 32 weeks

    Arm title
    		 MEDI6570 150 mg
    Arm description
    		 Participants received MEDI6570 150 mg every 4 weeks for 32 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI6570
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 1 injection (1.5 mL) of MEDI6570 150 mg every 4 weeks for 32 weeks

    Arm title
    		 MEDI6570 400 mg
    Arm description
    		 Participants received MEDI6570 400 mg every 4 weeks for 32 weeks. 8 participants initially randomized to 250 mg that switched dose to 400 mg during the trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI6570
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 2 injections (2 mL per injection) of MEDI6570 400 mg every 4 weeks for 32 weeks

    Arm title
    		 Placebo
    Arm description
    		 Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received injection (s) of matched placebo every 4 weeks for 32 weeks

    Number of subjects in period 1
    		MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Started
    40
    129
    126
    128
    Completed
    35
    126
    118
    117
    Not completed
    5
    3
    8
    11
         Adverse event, serious fatal
    -
    1
    1
    -
         Consent withdrawn by subject
    3
    2
    6
    6
         Adverse event, non-fatal
    1
    -
    1
    3
         Subjects who did not receive treatment
    1
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MEDI6570 50 mg
    Reporting group description
    		 Participants received MEDI6570 50 mg every 4 weeks for 32 weeks

    Reporting group title
    MEDI6570 150 mg
    Reporting group description
    		 Participants received MEDI6570 150 mg every 4 weeks for 32 weeks

    Reporting group title
    MEDI6570 400 mg
    Reporting group description
    		 Participants received MEDI6570 400 mg every 4 weeks for 32 weeks. 8 participants initially randomized to 250 mg that switched dose to 400 mg during the trial.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks

    Reporting group values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo Total
    Number of subjects
    		 40 129 126 128 423
    Age categorical
    Units: Subjects
        ≥ 21 to < 40 years
    		 0 1 1 0 2
        ≥ 40 to < 50 years
    		 4 18 21 17 60
        ≥ 50 to < 65 years
    		 25 66 64 68 223
        ≥ 65 years
    		 11 44 40 43 138
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 60.1 ( 8.3 ) 59.9 ( 9.2 ) 59.4 ( 9.6 ) 60.4 ( 9.5 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 12 19 23 21 75
        Male
    		 28 110 103 107 348
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 5 2 7 19
        Not Hispanic or Latino
    		 35 124 124 121 404
        Unknown
    		 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 0 0 0 1 1
        ASIAN
    		 7 10 8 9 34
        BLACK OR AFRICAN AMERICAN
    		 0 1 0 0 1
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    		 0 1 0 0 1
        OTHER
    		 0 1 0 0 1
        WHITE
    		 33 116 118 118 385
    Region of Enrollment
    Units: Subjects
        Australia
    		 0 6 6 3 15
        Canada
    		 0 3 1 0 4
        Czech Republic
    		 2 17 17 18 54
        Hungary
    		 9 11 12 23 55
        Italy
    		 0 14 21 19 54
        Japan
    		 7 9 8 8 32
        Netherlands
    		 1 18 11 11 41
        Poland
    		 2 14 14 10 40
        Spain
    		 13 20 18 18 69
        United Kingdom
    		 0 5 5 1 11
        United States of America
    		 6 12 13 17 48
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 33 116 118 118 385
        Non-caucasian
    		 7 13 8 10 38
        Missing
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    MEDI6570 50 mg
    Reporting group description
    		 Participants received MEDI6570 50 mg every 4 weeks for 32 weeks

    Reporting group title
    MEDI6570 150 mg
    Reporting group description
    		 Participants received MEDI6570 150 mg every 4 weeks for 32 weeks

    Reporting group title
    MEDI6570 400 mg
    Reporting group description
    		 Participants received MEDI6570 400 mg every 4 weeks for 32 weeks. 8 participants initially randomized to 250 mg that switched dose to 400 mg during the trial.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo matched to MEDI6570 every 4 weeks for 32 weeks

    Primary: Change from baseline to Day 253 in non-calcified plaque volume in the most diseased coronary segment (NCPVMD), as measured by CTA imaging

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    End point title
    		 Change from baseline to Day 253 in non-calcified plaque volume in the most diseased coronary segment (NCPVMD), as measured by CTA imaging
    End point description
    To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.
    End point type
    Primary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    34
    125
    116
    117
    Units: mm3
        least squares mean (standard error)
    -15.3220 ( 4.9219 )
    -4.5509 ( 3.1654 )
    -6.3658 ( 3.2559 )
    -6.9424 ( 3.2729 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.065 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean difference
    Point estimate
    -8.3797
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -17.498
         upper limit
    		 0.7387
    Notes
    [1] - One-sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.563 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean difference
    Point estimate
    0.5766
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.4389
         upper limit
    		 6.5921
    Notes
    [2] - One-sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.747 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean difference
    Point estimate
    2.3915
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.5338
         upper limit
    		 8.3167
    Notes
    [3] - One-sided p-value

    Secondary: Change from baseline to Day 253 in NT-proBNP

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    End point title
    		 Change from baseline to Day 253 in NT-proBNP
    End point description
    To evaluate the effect of MEDI6570 on a surrogate biomarker of HF compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    35
    125
    123
    118
    Units: pg/mL
        geometric mean (geometric coefficient of variation)
    0.8226 ( 9.4 )
    0.7787 ( 5.5 )
    0.7368 ( 5.6 )
    0.7370 ( 5.6 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.854 [4]
    Method
    		 Mixed model with repeated measurements
    Parameter type
    		 Geometric LS mean ratio estimate
    Point estimate
    1.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.33
    Notes
    [4] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.498 [5]
    Method
    		 Mixed model with repeated measurements
    Parameter type
    		 Geometric LS mean ratio estimate
    Point estimate
    1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.12
    Notes
    [5] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.79 [6]
    Method
    		 Mixed model with repeated measurements
    Parameter type
    		 Geometric LS mean ratio estimate
    Point estimate
    1.06
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.18
    Notes
    [6] - One sided p-value

    Secondary: Change from baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)

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    End point title
    		 Change from baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)
    End point description
    To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    31
    115
    112
    103
    Units: Percentage
        least squares mean (standard error)
    -0.91 ( 0.55 )
    0.32 ( 0.34 )
    0.11 ( 0.35 )
    0.53 ( 0.35 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.99 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -1.44
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.44
         upper limit
    		 -0.43
    Notes
    [7] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.849 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.08
         upper limit
    		 0.25
    Notes
    [8] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    218
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.697 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 0.45
    Notes
    [9] - One sided p-value

    Secondary: Left ventricular ejection fraction (LVEF) change from baseline to Day 253 among subjects with reduced ejection fraction (< 50%)

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    End point title
    		 Left ventricular ejection fraction (LVEF) change from baseline to Day 253 among subjects with reduced ejection fraction (< 50%)
    End point description
    To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as <50%) compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    7
    13
    20
    14
    Units: Percentage
        least squares mean (standard error)
    -1.08 ( 1.52 )
    1.32 ( 1.13 )
    2.09 ( 1.00 )
    2.41 ( 1.04 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.972 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -3.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -6.49
         upper limit
    		 -0.5
    Notes
    [10] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.596 [11]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.54
         upper limit
    		 1.89
    Notes
    [11] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.777 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.49
         upper limit
    		 1.3
    Notes
    [12] - One sided p-value

    Secondary: Change from baseline to Day 253 in Global Longitudinal Strain (GLS)

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    End point title
    		 Change from baseline to Day 253 in Global Longitudinal Strain (GLS)
    End point description
    To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    29
    105
    109
    100
    Units: Percentage
        least squares mean (standard error)
    -1.20 ( 0.56 )
    -0.70 ( 0.35 )
    -0.77 ( 0.35 )
    0.09 ( 0.35 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.981 [13]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -1.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.32
         upper limit
    		 -0.27
    Notes
    [13] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.983 [14]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.86
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.53
         upper limit
    		 -0.2
    Notes
    [14] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.974 [15]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 -0.12
    Notes
    [15] - One sided p-value

    Secondary: Global longitudinal strain (GLS) change from baseline to Day 253 among subjects with reduced ejection fraction (< 50%)

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    End point title
    		 Global longitudinal strain (GLS) change from baseline to Day 253 among subjects with reduced ejection fraction (< 50%)
    End point description
    To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as <50%) compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    6
    12
    20
    15
    Units: Percentage
        least squares mean (standard error)
    -0.39 ( 1.03 )
    -1.16 ( 0.78 )
    0.41 ( 0.64 )
    1.76 ( 0.66 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.959 [16]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -2.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.16
         upper limit
    		 -0.12
    Notes
    [16] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.998 [17]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -2.92
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.53
         upper limit
    		 -1.31
    Notes
    [17] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.939 [18]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -1.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.79
         upper limit
    		 0.09
    Notes
    [18] - One sided p-value

    Secondary: Change from baseline to Day 253 in Global non-calcified plaque volume (NCPV)

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    End point title
    		 Change from baseline to Day 253 in Global non-calcified plaque volume (NCPV)
    End point description
    To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    34
    125
    116
    117
    Units: mm3
        least squares mean (standard error)
    -26.4453 ( 10.0524 )
    -10.9010 ( 6.4671 )
    -10.4850 ( 6.6607 )
    -10.3083 ( 6.7052 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.077 [19]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -16.137
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -34.7829
         upper limit
    		 2.5089
    Notes
    [19] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.491 [20]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.1767
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12.4678
         upper limit
    		 12.1144
    Notes
    [20] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.468 [21]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.5927
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12.7267
         upper limit
    		 11.5413
    Notes
    [21] - One sided p-value

    Secondary: Change from baseline to Day 253 in Low attenuation plaque volume (LAPV)

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    End point title
    		 Change from baseline to Day 253 in Low attenuation plaque volume (LAPV)
    End point description
    To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 253
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    34
    125
    116
    117
    Units: mm3
        least squares mean (standard error)
    -7.9167 ( 3.5226 )
    -4.8101 ( 2.2690 )
    -4.2748 ( 2.3363 )
    -3.5733 ( 2.3481 )
    Statistical analysis title
    		 Comparing groups: MEDI6570 50 mg vs Placebo
    Comparison groups
    MEDI6570 50 mg v Placebo
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.136 [22]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -4.3435
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.8637
         upper limit
    		 2.1768
    Notes
    [22] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 400 mg vs Placebo
    Comparison groups
    MEDI6570 400 mg v Placebo
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.394 [23]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -0.7015
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.0096
         upper limit
    		 3.6065
    Notes
    [23] - One sided p-value
    Statistical analysis title
    		 Comparing groups: MEDI6570 150 mg vs Placebo
    Comparison groups
    MEDI6570 150 mg v Placebo
    Number of subjects included in analysis
    242
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.316 [24]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares mean difference
    Point estimate
    -1.2369
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -5.4796
         upper limit
    		 3.0059
    Notes
    [24] - One sided p-value

    Secondary: Summary of ADA Responses During the Study

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    End point title
    		 Summary of ADA Responses During the Study
    End point description
    To evaluate the immunogenicity of MEDI6570
    End point type
    Secondary
    End point timeframe
    From baseline to end of the study
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    39
    129
    126
    126
    Units: Participants
        ADA prevalence(positive at baseline/post-baseline)
    2
    10
    3
    1
        ADA incidence (TEADA positive)
    2
    9
    2
    1
        Treatment-induced ADA positive
    2
    9
    2
    1
        Treatment-boosted ADA positive
    0
    1
    0
    0
        ADA persistently positive
    2
    7
    1
    1
    No statistical analyses for this end point

    Secondary: Anti-drug antibody Titre summary by visit

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    End point title
    		 Anti-drug antibody Titre summary by visit
    End point description
    To evaluate the immunogenicity of MEDI6570
    End point type
    Secondary
    End point timeframe
    From Baseline to Day 325/405
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    39
    129
    126
    126
    Units: Titer units
    median (full range (min-max))
        Baseline
    0 (0 to 0)
    80 (80 to 80)
    320 (320 to 320)
    0 (0 to 0)
        Day 29
    0 (0 to 0)
    640 (640 to 640)
    0 (0 to 0)
    0 (0 to 0)
        Day 57
    0 (0 to 0)
    80 (80 to 80)
    0 (0 to 0)
    0 (0 to 0)
        Day 113
    640 (640 to 640)
    640 (640 to 640)
    0 (0 to 0)
    0 (0 to 0)
        Day 169
    320 (320 to 320)
    1600 (640 to 2560)
    0 (0 to 0)
    0 (0 to 0)
        Day 253
    160 (160 to 160)
    1360 (160 to 2560)
    80 (80 to 80)
    0 (0 to 0)
        Day 325/405
    120.0 (80 to 160)
    320 (80 to 1280)
    80 (80 to 80)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Summary of serum concentrations (ug/mL) of MEDI6570

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    End point title
    		 Summary of serum concentrations (ug/mL) of MEDI6570 [25]
    End point description
    MEDI6570 concentrations as measured in serum during the intervention and follow-up periods
    End point type
    Secondary
    End point timeframe
    From baseline to Day 325/Day 405
    Notes
    [25] - 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: The Placebo group is not reported for this endpoint.
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg
    Number of subjects analysed
    38
    129
    117
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Baseline (enter zero for values below LLOQ)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Day 10
    2.3126 ( 101.5 )
    7.0296 ( 125.9 )
    20.4472 ( 37.2 )
        Day 29
    0.6154 ( 170.7 )
    3.4641 ( 103.2 )
    9.5328 ( 115.4 )
        Day 57
    0.7622 ( 235.5 )
    4.3897 ( 145.9 )
    15.0108 ( 50.3 )
        Day 85
    1.1353 ( 217.3 )
    6.4317 ( 62.0 )
    10.8714 ( 608.2 )
        Day 113
    1.0084 ( 176.7 )
    5.4403 ( 120.1 )
    15.5611 ( 77.1 )
        Day 122
    4.6703 ( 37.0 )
    8.1229 ( 792.0 )
    28.1805 ( 168.8 )
        Day 141
    1.4191 ( 129.5 )
    8.0736 ( 47.2 )
    10.4080 ( 647.5 )
        Day 169
    0.8016 ( 171.6 )
    5.2865 ( 163.4 )
    15.9449 ( 145.9 )
        Day 197 (enter zero for values below LLOQ)
    0 ( 0 )
    0 ( 0 )
    0 ( 0 )
        Day 225 (enter zero for values below LLOQ)
    2.2469 ( 86.3 )
    3.6384 ( 633.4 )
    0 ( 0 )
        Day 253
    0.7253 ( 288.4 )
    5.6832 ( 136.0 )
    14.9944 ( 173.4 )
        Day 325/Day 405 (enter zero for values below LLOQ)
    0 ( 0 )
    0 ( 0 )
    0.5955 ( 720.6 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events in Any Category

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    End point title
    		 Number of Participants with Adverse Events in Any Category
    End point description
    To assess the safety and tolerability of MEDI6570 compared with placebo
    End point type
    Secondary
    End point timeframe
    During study follow-up
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    39
    129
    126
    126
    Units: participants
        Any AEs|n (%)
    26
    87
    79
    65
        Any AEs with outcome of death|n (%)
    0
    1
    1
    0
        Any SAE (including events with outcome of death)
    4
    17
    10
    13
        Any AE leading to treatment discontinuation|n (%)
    1
    0
    2
    3
        Any AE leading to withdrawal from study|n (%)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Most Common Adverse Events (Frequency > 5%)

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    End point title
    		 Number of Participants with Most Common Adverse Events (Frequency > 5%)
    End point description
    To assess the safety and tolerability of MEDI6570 compared with placebo
    End point type
    Secondary
    End point timeframe
    During study follow-up
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    39
    129
    126
    126
    Units: participants
        Participants with any AE|n (%)
    16
    35
    38
    26
        COVID-19|n (%)
    3
    8
    17
    6
        Hypertension|n (%)
    2
    4
    9
    9
        Non-cardiac chest pain|n (%)
    3
    5
    6
    4
        Dyspnoea|n (%)
    2
    3
    4
    3
        Hypotension|n (%)
    2
    1
    4
    1
        Angina pectoris|n (%)
    2
    10
    3
    6
        Pyrexia|n (%)
    2
    1
    3
    1
        Diarrhoea|n (%)
    2
    5
    2
    4
        Epistaxis|n (%)
    2
    1
    2
    1
        Influenza|n (%)
    2
    4
    2
    1
        Nausea|n (%)
    2
    1
    1
    1
        Pain in extremity|n (%)
    2
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Vital signs and electrocardiogram (ECG) variables over time

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    End point title
    		 Vital signs and electrocardiogram (ECG) variables over time
    End point description
    To assess the safety and tolerability of MEDI6570 compared with placebo
    End point type
    Secondary
    End point timeframe
    From baseline to Day 325/405
    End point values
    		 MEDI6570 50 mg MEDI6570 150 mg MEDI6570 400 mg Placebo
    Number of subjects analysed
    39
    129
    126
    126
    Units: Unit vary for each Vital signs variable
    arithmetic mean (standard deviation)
        Systolic blood pressure (mmHg) Day 10
    0.3 ( 9.9 )
    0.9 ( 12.7 )
    -1.4 ( 13.0 )
    0.4 ( 12.8 )
        Systolic blood pressure (mmHg) Day 29
    -0.7 ( 10.8 )
    -1.1 ( 14.6 )
    -1.5 ( 11.9 )
    -1.3 ( 12.6 )
        Systolic blood pressure (mmHg) Day 57
    1.4 ( 11.6 )
    0.7 ( 14.1 )
    -1.6 ( 12.3 )
    -0.1 ( 12.8 )
        Systolic blood pressure (mmHg) Day 85
    0.7 ( 10.2 )
    1.5 ( 13.8 )
    -1.2 ( 12.7 )
    -0.5 ( 14.9 )
        Systolic blood pressure (mmHg) Day 113
    -0.6 ( 10.6 )
    1.3 ( 15.2 )
    0.2 ( 13.7 )
    0.6 ( 13.1 )
        Systolic blood pressure (mmHg) Day 122
    1.6 ( 16.4 )
    -4.0 ( 15.5 )
    -2.0 ( 13.8 )
    7.8 ( 17.1 )
        Systolic blood pressure (mmHg) Day 141
    0.7 ( 15.0 )
    -0.2 ( 14.1 )
    -0.2 ( 14.1 )
    0.8 ( 13.3 )
        Systolic blood pressure (mmHg) Day 169
    1.2 ( 13.4 )
    1.5 ( 12.5 )
    -0.3 ( 14.9 )
    0.5 ( 14.5 )
        Systolic blood pressure (mmHg) Day 197
    0.7 ( 15.8 )
    0.6 ( 14.0 )
    -3.6 ( 13.5 )
    -0.4 ( 13.6 )
        Systolic blood pressure (mmHg) Day 225
    2.8 ( 14.3 )
    1.7 ( 14.8 )
    -0.6 ( 15.1 )
    -0.3 ( 14.7 )
        Systolic blood pressure (mmHg) Day 253
    -1.8 ( 15.5 )
    0.7 ( 14.4 )
    -0.9 ( 15.6 )
    0.2 ( 14.5 )
        Systolic blood pressure (mmHg) Day 325/405
    -1.8 ( 12.8 )
    0.7 ( 14.1 )
    -2.5 ( 14.7 )
    0.1 ( 16.0 )
        Diastolic blood pressure (mmHg) Day 10
    -0.2 ( 6.0 )
    0.6 ( 8.5 )
    -0.3 ( 8.4 )
    -0.4 ( 8.7 )
        Diastolic blood pressure (mmHg) Day 29
    0.3 ( 8.5 )
    -1.3 ( 8.7 )
    -1.1 ( 9.7 )
    -1.3 ( 9.1 )
        Diastolic blood pressure (mmHg) Day 57
    -1.1 ( 8.5 )
    -0.5 ( 8.4 )
    -0.9 ( 8.9 )
    -0.4 ( 8.5 )
        Diastolic blood pressure (mmHg) Day 85
    -0.1 ( 9.0 )
    -0.5 ( 10.5 )
    -0.9 ( 8.9 )
    -0.6 ( 9.2 )
        Diastolic blood pressure (mmHg) Day 113
    -0.3 ( 8.5 )
    0.1 ( 9.4 )
    -0.5 ( 8.9 )
    1.0 ( 9.1 )
        Diastolic blood pressure (mmHg) Day 122
    -3.7 ( 10.4 )
    -3.9 ( 8.0 )
    -2.0 ( 7.5 )
    4.1 ( 12.3 )
        Diastolic blood pressure (mmHg) Day 141
    -1.5 ( 8.4 )
    -1.1 ( 9.6 )
    -0.3 ( 8.5 )
    0.2 ( 7.9 )
        Diastolic blood pressure (mmHg) Day 169
    -0.4 ( 9.5 )
    -0.3 ( 9.2 )
    -0.8 ( 9.0 )
    -0.4 ( 9.2 )
        Diastolic blood pressure (mmHg) Day 197
    -1.6 ( 7.7 )
    0.0 ( 9.5 )
    -2.0 ( 9.8 )
    -0.3 ( 9.0 )
        Diastolic blood pressure (mmHg) Day 225
    0.4 ( 9.5 )
    -1.6 ( 9.8 )
    -0.9 ( 8.8 )
    -0.8 ( 8.4 )
        Diastolic blood pressure (mmHg) Day 253
    -3.7 ( 7.9 )
    -0.1 ( 10.7 )
    -1.0 ( 9.9 )
    -0.4 ( 9.3 )
        Diastolic blood pressure (mmHg) Day 325/405
    -1.8 ( 8.5 )
    -0.5 ( 9.1 )
    -1.5 ( 10.3 )
    -0.7 ( 9.8 )
        Heart rate (beats/min) Day 10
    0.4 ( 9.4 )
    0.6 ( 8.0 )
    0.4 ( 6.9 )
    -0.6 ( 8.6 )
        Heart rate (beats/min) Day 29
    -0.5 ( 11.4 )
    0.7 ( 8.3 )
    1.3 ( 8.2 )
    -1.1 ( 8.5 )
        Heart rate (beats/min) Day 57
    -2.1 ( 11.0 )
    0.9 ( 8.9 )
    2.5 ( 9.7 )
    1.1 ( 11.1 )
        Heart rate (beats/min) Day 85
    -3.3 ( 9.4 )
    1.0 ( 9.2 )
    2.3 ( 8.3 )
    1.3 ( 10.4 )
        Heart rate (beats/min) Day 113
    -1.8 ( 9.8 )
    0.5 ( 10.1 )
    0.2 ( 8.7 )
    0.2 ( 10.7 )
        Heart rate (beats/min) Day 122
    -3.3 ( 10.8 )
    -1.2 ( 13.4 )
    -1.3 ( 7.6 )
    0.7 ( 16.0 )
        Heart rate (beats/min) Day 141
    -1.3 ( 10.4 )
    0.8 ( 9.2 )
    2.0 ( 9.4 )
    2.2 ( 10.4 )
        Heart rate (beats/min) Day 169
    0.7 ( 10.1 )
    0.5 ( 11.0 )
    3.0 ( 8.8 )
    1.5 ( 9.7 )
        Heart rate (beats/min) Day 197
    2.1 ( 12.5 )
    2.3 ( 9.8 )
    1.7 ( 9.5 )
    1.8 ( 10.4 )
        Heart rate (beats/min) Day 225
    0.9 ( 10.0 )
    1.2 ( 11.0 )
    2.5 ( 10.1 )
    1.8 ( 10.4 )
        Heart rate (beats/min) Day 253
    -0.8 ( 12.2 )
    0.2 ( 11.0 )
    2.1 ( 10.0 )
    0.4 ( 9.4 )
        Heart rate (beats/min) Day 325/405
    0.5 ( 10.4 )
    1.3 ( 9.8 )
    1.9 ( 9.4 )
    0.7 ( 9.9 )
        Weight (kg) Day 325/405
    0.316 ( 4.550 )
    1.445 ( 4.863 )
    1.078 ( 4.714 )
    0.786 ( 5.348 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    PLACEBO
    Reporting group description
    		 -

    Reporting group title
    MEDI6570 150 mg
    Reporting group description
    		 -

    Reporting group title
    MEDI6570 50 mg
    Reporting group description
    		 -

    Reporting group title
    MEDI6570 400 mg
    Reporting group description
    		 -

    Serious adverse events
    		 PLACEBO MEDI6570 150 mg MEDI6570 50 mg MEDI6570 400 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 126 (10.32%)
    17 / 129 (13.18%)
    4 / 39 (10.26%)
    10 / 126 (7.94%)
         number of deaths (all causes)
    0
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 126 (0.79%)
    3 / 129 (2.33%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    3 / 126 (2.38%)
    3 / 129 (2.33%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Omental necrosis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Stag horn calculus
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 PLACEBO MEDI6570 150 mg MEDI6570 50 mg MEDI6570 400 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 126 (51.59%)
    87 / 129 (67.44%)
    26 / 39 (66.67%)
    79 / 126 (62.70%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal adenoma
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemangioma of liver
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neoplasm skin
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 126 (7.14%)
    4 / 129 (3.10%)
    2 / 39 (5.13%)
    9 / 126 (7.14%)
         occurrences all number
    9
    5
    2
    9
    Hypotension
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    2 / 39 (5.13%)
    4 / 126 (3.17%)
         occurrences all number
    1
    1
    2
    5
    Aortic aneurysm
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Aortic stenosis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Ischaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Phlebitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Superior vena cava syndrome
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematoma
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    1
    2
    1
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    2 / 39 (5.13%)
    3 / 126 (2.38%)
         occurrences all number
    1
    1
    2
    4
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 126 (3.17%)
    5 / 129 (3.88%)
    2 / 39 (5.13%)
    6 / 126 (4.76%)
         occurrences all number
    4
    5
    2
    8
    Induration
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    4 / 126 (3.17%)
         occurrences all number
    0
    2
    0
    5
    Chest discomfort
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    0
    1
    0
    3
    Chest pain
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cyst
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    1 / 39 (2.56%)
    5 / 126 (3.97%)
         occurrences all number
    1
    2
    1
    5
    Haemorrhagic cyst
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Hyperpyrexia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site bruising
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Injection site erythema
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    2
    Injection site pain
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 129 (1.55%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    3
    3
    1
    2
    Injection site swelling
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injection site urticaria
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 126 (1.59%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    2
    0
    0
    1
    Balanoposthitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    1
    1
    Endometrial thickening
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Genital tract inflammation
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hydrometra
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Prostatitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 126 (2.38%)
    3 / 129 (2.33%)
    2 / 39 (5.13%)
    4 / 126 (3.17%)
         occurrences all number
    3
    4
    2
    5
    Epistaxis
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    2 / 39 (5.13%)
    2 / 126 (1.59%)
         occurrences all number
    1
    1
    2
    4
    Oropharyngeal pain
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    2
    Atelectasis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 126 (0.79%)
    5 / 129 (3.88%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    1
    5
    1
    1
    Dyspnoea exertional
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Haemoptysis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperventilation
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Laryngospasm
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sputum retention
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pleural thickening
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Tension
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    2
    Drug abuse
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    0
    2
    Nightmare
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Stress
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Anxiety
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    0
    1
    Investigations
    Electrocardiogram ST segment abnormal
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Differential white blood cell count abnormal
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    3
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    0
    1
    Bacterial test positive
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Heart rate increased
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Bleeding time prolonged
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somatosensory evoked potentials abnormal
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    4 / 126 (3.17%)
         occurrences all number
    1
    2
    0
    7
    Arthropod bite
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Arthropod sting
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Craniofacial fracture
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Immunisation reaction
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Joint injury
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    2
    Ligament sprain
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Muscle strain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Post procedural haematoma
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    1
    Scar
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    0
    2
    Fall
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    0
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    4 / 126 (3.17%)
    7 / 129 (5.43%)
    1 / 39 (2.56%)
    3 / 126 (2.38%)
         occurrences all number
    4
    7
    1
    4
    Cardiac failure
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    0
    2
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myocardial infarction
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    2
    0
    0
    1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Palpitations
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    2
    0
    0
    2
    Sinus tachycardia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Tachyarrhythmia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ventricular hypokinesia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nervous system disorders
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral atrophy
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Carotid artery disease
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    3 / 126 (2.38%)
    6 / 129 (4.65%)
    1 / 39 (2.56%)
    2 / 126 (1.59%)
         occurrences all number
    3
    6
    1
    2
    Dizziness postural
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Epilepsy
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    3
    Hand-eye coordination impaired
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    2
    2
    0
    2
    Hypoaesthesia
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    0
    2
    Radiculopathy
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Seizure
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Spinal cord infarction
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Syncope
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    4 / 126 (3.17%)
         occurrences all number
    0
    3
    0
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 126 (2.38%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    3
    1
    0
    1
    Granulomatous lymphadenitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctival suffusion
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Non-proliferative retinopathy
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eye irritation
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 126 (3.17%)
    5 / 129 (3.88%)
    2 / 39 (5.13%)
    2 / 126 (1.59%)
         occurrences all number
    4
    5
    2
    2
    Nausea
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    2 / 39 (5.13%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    2
    1
    Diverticulum intestinal
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    0
    1
    Constipation
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Colitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anal fissure
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    1
    0
    2
    Abdominal distension
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Duodenitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Tooth erosion
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    0
    0
    0
    3
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 126 (1.59%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Small intestine ulcer
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Mesenteric panniculitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 126 (0.00%)
    4 / 129 (3.10%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    0
    4
    0
    2
    Hepatobiliary disorders
    Gallbladder cholesterolosis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic steatosis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    1
    2
    Psoriasis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    1 / 126 (0.79%)
    2 / 129 (1.55%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    1
    2
    1
    1
    Rash macular
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Skin hypertrophy
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Intertrigo
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Bladder hypertrophy
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    0
    1
    0
    4
    Renal colic
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal impairment
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Endocrine disorders
    Graves' disease
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    2 / 39 (5.13%)
    1 / 126 (0.79%)
         occurrences all number
    2
    1
    2
    1
    Muscular weakness
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    2 / 126 (1.59%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    2
    2
    0
    2
    Arthritis
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Back pain
         subjects affected / exposed
    3 / 126 (2.38%)
    4 / 129 (3.10%)
    1 / 39 (2.56%)
    3 / 126 (2.38%)
         occurrences all number
    3
    4
    1
    4
    Bursitis
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Costochondritis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 126 (0.00%)
    3 / 129 (2.33%)
    0 / 39 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    0
    3
    0
    3
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    3 / 126 (2.38%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    3 / 126 (2.38%)
         occurrences all number
    5
    2
    0
    3
    Osteoarthritis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Plantar fasciitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tendon pain
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 126 (0.79%)
    4 / 129 (3.10%)
    2 / 39 (5.13%)
    2 / 126 (1.59%)
         occurrences all number
    1
    4
    2
    2
    Otitis externa
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Abscess oral
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anal abscess
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    COVID-19
         subjects affected / exposed
    6 / 126 (4.76%)
    8 / 129 (6.20%)
    2 / 39 (5.13%)
    16 / 126 (12.70%)
         occurrences all number
    6
    8
    2
    17
    Conjunctivitis viral
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    1
    Gingivitis
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Mastitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 126 (2.38%)
    4 / 129 (3.10%)
    1 / 39 (2.56%)
    3 / 126 (2.38%)
         occurrences all number
    3
    4
    1
    3
    Orchitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Osteomyelitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    1
    1
    Pulpitis dental
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Purulence
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tinea infection
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tinea pedis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 126 (0.00%)
    4 / 129 (3.10%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    0
    4
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 126 (0.79%)
    1 / 129 (0.78%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 129 (0.78%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    1
    2
    Decreased appetite
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    1 / 39 (2.56%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    1
    1
    Diabetes mellitus
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 126 (0.00%)
    2 / 129 (1.55%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    4 / 126 (3.17%)
    2 / 129 (1.55%)
    1 / 39 (2.56%)
    0 / 126 (0.00%)
         occurrences all number
    4
    2
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 129 (0.00%)
    0 / 39 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2021
    The overall rationale for the amendment, given the complexity and burden of the current trial configuration and the corresponding impact on recruitment, is to simplify the protocol to reduce the patient burden and be more patient-centric. The protocol has a reduced total sample size while maintaining the assessment of the primary endpoint at a slightly reduced power and increased type 1 error.

    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.
    None reported
    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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