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    Clinical Trial Results:
    A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease with Type 2 Diabetes.

    Summary
    EudraCT number
    2020-000255-12
    Trial protocol
    GB   DE  
    Global end of trial date
    08 Mar 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Mar 2023
    First version publication date
    20 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5676C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04515849
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Granta Park, Cambridge, United Kingdom, CB21 6GH
    Public contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, 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
    21 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This Phase 2b study is designed to evaluate the efficacy, safety, tolerability, and pharmacokinetic (PK) profile of cotadutide at different dose levels in participants who have CKD with T2DM.
    Protection of trial subjects
    In the study, fasting was minimised and continuous glucose monitoring (CGM) was used instead of more invasive glucose measures to reduce participant discomfort.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Aug 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
    Japan: 26
    Country: Number of subjects enrolled
    Spain: 61
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Canada: 59
    Country: Number of subjects enrolled
    New Zealand: 31
    Country: Number of subjects enrolled
    Australia: 18
    Worldwide total number of subjects
    248
    EEA total number of subjects
    111
    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)
    77
    From 65 to 84 years
    171
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted at 79 participating sites in Canada, Australia, New Zealand, Japan, Germany, Poland, Spain and United Kingdom. First subject enrolled 31st August 2020. Last subject last visit: 28th June 2021.

    Pre-assignment
    Screening details
    This is a parallel treatment, double-blind study with 5 arms.The study had a 14-day run-in period during which participants will be given advice on diet and exercise and asked to wear a CGM sensor, followed by a 26-week treatment period and 28-day follow-up period.

    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
    Investigator, Monitor, Carer, Data analyst, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cotadutide 100 ug
    Arm description
    Participants randomised to Cotadutide 100 ug daily
    Arm type
    Experimental

    Investigational medicinal product name
    Cotadutide 100 ug
    Investigational medicinal product code
    MEDI0382
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 ug, subcutaneous

    Arm title
    Cotadutide 300 ug
    Arm description
    Participants randomised to Cotadutide 300 ug daily
    Arm type
    Experimental

    Investigational medicinal product name
    Cotadutide 300 ug
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 ug, Subcutaneous

    Arm title
    Cotadutide 600 ug
    Arm description
    Participants randomised to Cotadutide 600 ug daily
    Arm type
    Experimental

    Investigational medicinal product name
    Cotadutide 600 ug
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    600 ug, subcutaneous

    Arm title
    Placebo
    Arm description
    Participants randomised to placebo daily
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    subcutaneous

    Arm title
    Semaglutide 1 mg
    Arm description
    Participants radomised to active comparator daily
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo Semaglutide 1 mg
    Started
    52
    49
    51
    51
    45
    Completed
    49
    45
    50
    48
    43
    Not completed
    3
    4
    1
    3
    2
         Adverse event, serious fatal
    2
    -
    -
    -
    1
         Consent withdrawn by subject
    1
    2
    1
    -
    -
         Other:randomised by error
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    1
    -
         Other:family emergency
    -
    -
    -
    1
    -
         Protocol deviation
    -
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cotadutide 100 ug
    Reporting group description
    Participants randomised to Cotadutide 100 ug daily

    Reporting group title
    Cotadutide 300 ug
    Reporting group description
    Participants randomised to Cotadutide 300 ug daily

    Reporting group title
    Cotadutide 600 ug
    Reporting group description
    Participants randomised to Cotadutide 600 ug daily

    Reporting group title
    Placebo
    Reporting group description
    Participants randomised to placebo daily

    Reporting group title
    Semaglutide 1 mg
    Reporting group description
    Participants radomised to active comparator daily

    Reporting group values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo Semaglutide 1 mg Total
    Number of subjects
    52 49 51 51 45 248
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0
        Adults (18-64 years)
    17 13 23 10 14 77
        From 65-84 years
    35 36 28 41 31 171
        85 years and over
    0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    67.2 ± 7.3 65.7 ± 8.8 66.1 ± 7.4 69.5 ± 7.3 67.0 ± 7.8 -
    Sex: Female, Male
    Units: Participants
        Female
    9 3 10 13 12 47
        Male
    43 46 41 38 33 201
    Race (NIH/OMB)
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    0 0 0 0 0 0
        ASIAN
    10 10 13 10 2 45
        BLACK OR AFRICAN AMERICAN
    2 0 0 1 2 5
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    2 0 1 1 0 4
        OTHER
    0 3 1 0 0 4
        WHITE
    38 36 36 39 41 190
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intent to treat

    Subject analysis sets values
    ITT
    Number of subjects
    248
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    171
        From 65-84 years
    77
        85 years and over
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    67.1 ± 7.8
    Sex: Female, Male
    Units: Participants
        Female
        Male
    Race (NIH/OMB)
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
        ASIAN
        BLACK OR AFRICAN AMERICAN
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
        OTHER
        WHITE

    End points

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    End points reporting groups
    Reporting group title
    Cotadutide 100 ug
    Reporting group description
    Participants randomised to Cotadutide 100 ug daily

    Reporting group title
    Cotadutide 300 ug
    Reporting group description
    Participants randomised to Cotadutide 300 ug daily

    Reporting group title
    Cotadutide 600 ug
    Reporting group description
    Participants randomised to Cotadutide 600 ug daily

    Reporting group title
    Placebo
    Reporting group description
    Participants randomised to placebo daily

    Reporting group title
    Semaglutide 1 mg
    Reporting group description
    Participants radomised to active comparator daily

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intent to treat

    Primary: Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks

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    End point title
    Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks [1] [2]
    End point description
    Percentage change in UACR of cotadutide at different dose levels compared to placebo after 14 weeks. Efficacy endpoints for cotadutide vs. semaglutide are exploratory and are therefore excluded.
    End point type
    Primary
    End point timeframe
    Baseline to the end of 14 weeks of dosing
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    49
    43
    37
    43
    Units: UACR ratio
        least squares mean (confidence interval 95%)
    -10.96 (-29.60 to 12.61)
    -40.47 (-53.00 to -24.60)
    -44.60 (-56.21 to -29.91)
    4.60 (-18.02 to 33.46)
    No statistical analyses for this end point

    Secondary: Percentage change in UACR of cotadutide at different dose levels compared to placebo after 26 weeks

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    End point title
    Percentage change in UACR of cotadutide at different dose levels compared to placebo after 26 weeks [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 26 weeks of dosing
    Notes
    [3] - 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: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    49
    46
    48
    49
    Units: UACR ratio
        least squares mean (confidence interval 95%)
    -17.85 (-45.47 to 23.78)
    -38.68 (-59.61 to -6.88)
    -57.87 (-73.33 to -33.34)
    11.79 (-27.85 to 73.22)
    No statistical analyses for this end point

    Secondary: Percent change in body weight of cotatudide at different dose levels versus placebo from baseline to end of 14 weeks of dosing

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    End point title
    Percent change in body weight of cotatudide at different dose levels versus placebo from baseline to end of 14 weeks of dosing [4]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 14 weeks of dosing
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    37
    32
    27
    35
    Units: Absolute value
        least squares mean (standard error)
    -2.84 ± 0.65
    -4.15 ± 0.68
    -5.40 ± 0.73
    -1.61 ± 0.66
    No statistical analyses for this end point

    Secondary: Percentage change in body weight of cotatudide at different dose levels versus placebo from baseline to end of 26 weeks of dosing

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    End point title
    Percentage change in body weight of cotatudide at different dose levels versus placebo from baseline to end of 26 weeks of dosing [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 26 weeks of dosing
    Notes
    [5] - 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: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    37
    33
    27
    35
    Units: Absolute value
        least squares mean (standard error)
    -2.60 ± 0.89
    -5.45 ± 0.92
    -7.35 ± 0.99
    -2.23 ± 0.90
    No statistical analyses for this end point

    Secondary: Percent change in HbA1c of cotadutide at different dose levels versus placebo from baseline to the end of 14 of dosing

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    End point title
    Percent change in HbA1c of cotadutide at different dose levels versus placebo from baseline to the end of 14 of dosing [6]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 14 weeks of dosing
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    49
    45
    48
    39
    Units: Percent change
        least squares mean (standard error)
    -0.76 ± 0.12
    -0.82 ± 0.12
    -0.65 ± 0.12
    -0.08 ± 0.12
    No statistical analyses for this end point

    Secondary: Percent change in HbA1c of cotadutide at different dose levels versus placebo from baseline to the end of 26 of dosing

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    End point title
    Percent change in HbA1c of cotadutide at different dose levels versus placebo from baseline to the end of 26 of dosing [7]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 26 weeks of dosing
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    49
    46
    48
    39
    Units: Percent change
        least squares mean (standard error)
    -0.92 ± 0.11
    -0.92 ± 0.11
    -0.89 ± 0.11
    -0.25 ± 0.11
    No statistical analyses for this end point

    Secondary: Change in fasting glucose of cotadutide at different dose levels from baseline versus placebo after 14 weeks of dosing

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    End point title
    Change in fasting glucose of cotadutide at different dose levels from baseline versus placebo after 14 weeks of dosing [8]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 14 weeks of dosing
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    42
    45
    48
    49
    Units: mmol/L
        least squares mean (standard error)
    -1.35 ± 0.37
    -1.57 ± 0.35
    -1.69 ± 0.40
    -0.54 ± 0.37
    No statistical analyses for this end point

    Secondary: Change in fasting glucose of cotadutide at different dose levels from baseline versus placebo after 26 weeks of dosing

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    End point title
    Change in fasting glucose of cotadutide at different dose levels from baseline versus placebo after 26 weeks of dosing [9]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 26 weeks of dosing
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    45
    43
    39
    45
    Units: mmol/L
        least squares mean (standard error)
    -1.78 ± 0.36
    -1.76 ± 0.37
    -1.57 ± 0.39
    -0.72 ± 0.37
    No statistical analyses for this end point

    Secondary: Change in 10-day average glucose levels of cotadutide at different dose levels versus placebo from baseline to end of 14 weeks of dosing

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    End point title
    Change in 10-day average glucose levels of cotadutide at different dose levels versus placebo from baseline to end of 14 weeks of dosing [10]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 14 weeks of dosing
    Notes
    [10] - 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: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    30
    25
    26
    30
    Units: Percent change
        least squares mean (standard error)
    -1.556 ± 0.320
    -1.478 ± 0.337
    -1.269 ± 0.334
    -0.440 ± 0.311
    No statistical analyses for this end point

    Secondary: Change in 10-day average glucose levels of cotadutide at different dose levels versus placebo from baseline to end of 26 weeks of dosing

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    End point title
    Change in 10-day average glucose levels of cotadutide at different dose levels versus placebo from baseline to end of 26 weeks of dosing [11]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to end of 26 weeks of dosing
    Notes
    [11] - 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: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    25
    18
    22
    30
    Units: Percent change
        least squares mean (standard error)
    -1.735 ± 0.307
    -1.446 ± 0.334
    -1.118 ± 0.321
    -0.273 ± 0.290
    No statistical analyses for this end point

    Secondary: Change in percentage time spent in hyperglycaemia over 10 days of cotadutide at different dose levels compared to placebo after 14 weeks of dosing

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    End point title
    Change in percentage time spent in hyperglycaemia over 10 days of cotadutide at different dose levels compared to placebo after 14 weeks of dosing [12]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 14 weeks of dosing
    Notes
    [12] - 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: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    30
    25
    26
    30
    Units: Percent Change
        least squares mean (standard error)
    -13.87 ± 3.35
    -15.79 ± 3.55
    -13.90 ± 3.52
    -4.09 ± 3.27
    No statistical analyses for this end point

    Secondary: Change in percentage time spent in hyperglycaemia over 10 days of cotadutide at different dose levels compared to placebo after 26 weeks of dosing

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    End point title
    Change in percentage time spent in hyperglycaemia over 10 days of cotadutide at different dose levels compared to placebo after 26 weeks of dosing [13]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 26 weeks of dosing
    Notes
    [13] - 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: In this study, the efficacy efficacy endpoints vs. semaglutide are exploratory and were therefore excluded
    End point values
    Cotadutide 100 ug Cotadutide 300 ug Cotadutide 600 ug Placebo
    Number of subjects analysed
    25
    18
    22
    27
    Units: Percent change
        least squares mean (standard error)
    -18.06 ± 3.33
    -15.38 ± 3.76
    -11.91 ± 3.51
    -3.00 ± 3.17
    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
    24.1
    Reporting groups
    Reporting group title
    Cotadutide 300 ug
    Reporting group description
    -

    Reporting group title
    Cotadutide 100 ug
    Reporting group description
    -

    Reporting group title
    Semaglutide 1 mg
    Reporting group description
    -

    Reporting group title
    Cotadutide 600 ug
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Cotadutide 300 ug Cotadutide 100 ug Semaglutide 1 mg Cotadutide 600 ug Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 48 (10.42%)
    5 / 55 (9.09%)
    4 / 45 (8.89%)
    5 / 48 (10.42%)
    5 / 51 (9.80%)
         number of deaths (all causes)
    0
    2
    0
    0
    0
         number of deaths resulting from adverse events
    0
    2
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder with anxiety
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suspected suicide
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Ketosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Cotadutide 300 ug Cotadutide 100 ug Semaglutide 1 mg Cotadutide 600 ug Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 48 (79.17%)
    43 / 55 (78.18%)
    39 / 45 (86.67%)
    38 / 48 (79.17%)
    38 / 51 (74.51%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Adrenal neoplasm
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haemangioma of liver
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    B-cell lymphoma stage III
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    5 / 45 (11.11%)
    3 / 48 (6.25%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    5
    4
    0
    Haematoma
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    0
    1
    Aortic stenosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Surgical and medical procedures
    Meniscus removal
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin neoplasm excision
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Tooth extraction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    2 / 45 (4.44%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    0
    1
    Early satiety
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Injection site pain
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    1
    0
    0
    0
    2
    Injection site erythema
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 55 (5.45%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    3
    1
    1
    1
    Injection site pruritus
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 55 (3.64%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    0
    0
    1
    Malaise
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Oedema
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    0
    1
    0
    3
    Pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Puncture site haemorrhage
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 55 (3.64%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    2
    1
    0
    1
    Vaccination site pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    2
    0
    0
    2
    1
    Reproductive system and breast disorders
    Breast tenderness
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Allergic cough
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Atelectasis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Bronchiectasis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    3 / 51 (5.88%)
         occurrences all number
    1
    0
    0
    2
    3
    Dyspnoea
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    1
    0
    0
    0
    2
    Dyspnoea exertional
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    1
    1
    Pulmonary congestion
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    1
    1
    0
    0
    2
    Nasal congestion
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Rales
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    1
    1
    Sinus congestion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Sneezing
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 55 (3.64%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Cardiovascular somatic symptom disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Irritability
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Investigations
    Blood bicarbonate increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    3
    1
    Amylase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Blood calcium increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac murmur
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Electrocardiogram change
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood sodium increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood pressure decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    2 / 45 (4.44%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    0
    1
    Occult blood positive
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Ventricular internal diameter
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Urine output increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pulse absent
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pulmonary arterial pressure increased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Pedal pulse decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Arthropod bite
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Heat stroke
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Costal cartilage fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Epicondylitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    1
    1
    Heat illness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    6
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    3
    0
    0
    0
    1
    Ligament rupture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin pressure mark
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin wound
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tibia fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vaccination complication
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Angina unstable
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Conduction disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiac septal hypertrophy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    Atrial flutter
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    1
    1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pericardial effusion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Akinesia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 55 (1.82%)
    1 / 45 (2.22%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    4
    1
    1
    2
    1
    Cognitive disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dizziness postural
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    2 / 45 (4.44%)
    3 / 48 (6.25%)
    1 / 51 (1.96%)
         occurrences all number
    1
    1
    2
    5
    2
    Neuralgia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Myelopathy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ischaemic stroke
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Polyneuropathy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    1
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Blood loss anaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 55 (3.64%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Macular oedema
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Glaucoma
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Diabetic retinopathy
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    1
    2
    1
    Abdominal distension
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    1
    2
    0
    Diarrhoea
         subjects affected / exposed
    7 / 48 (14.58%)
    5 / 55 (9.09%)
    7 / 45 (15.56%)
    6 / 48 (12.50%)
    4 / 51 (7.84%)
         occurrences all number
    10
    5
    9
    9
    8
    Constipation
         subjects affected / exposed
    2 / 48 (4.17%)
    7 / 55 (12.73%)
    3 / 45 (6.67%)
    5 / 48 (10.42%)
    2 / 51 (3.92%)
         occurrences all number
    3
    7
    4
    7
    3
    Chronic gastritis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    0
    1
    Faeces hard
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    2
    1
    0
    2
    1
    Nausea
         subjects affected / exposed
    7 / 48 (14.58%)
    6 / 55 (10.91%)
    12 / 45 (26.67%)
    14 / 48 (29.17%)
    5 / 51 (9.80%)
         occurrences all number
    9
    7
    23
    18
    5
    Large intestine polyp
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 55 (1.82%)
    3 / 45 (6.67%)
    3 / 48 (6.25%)
    0 / 51 (0.00%)
         occurrences all number
    2
    1
    4
    3
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oral lichen planus
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 55 (3.64%)
    0 / 45 (0.00%)
    2 / 48 (4.17%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    Vomiting
         subjects affected / exposed
    3 / 48 (6.25%)
    2 / 55 (3.64%)
    7 / 45 (15.56%)
    7 / 48 (14.58%)
    2 / 51 (3.92%)
         occurrences all number
    4
    2
    9
    12
    2
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatomegaly
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    3
    1
    Dermal cyst
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blister
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Actinic keratosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lichenification
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Macule
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Scab
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin ulcer
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    Renal and urinary disorders
    Urinary hesitation
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal mass
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Polyuria
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Endocrine disorders
    Thyroid mass
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    2 / 48 (4.17%)
    3 / 51 (5.88%)
         occurrences all number
    1
    0
    2
    2
    3
    Joint swelling
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 55 (3.64%)
    2 / 45 (4.44%)
    3 / 48 (6.25%)
    4 / 51 (7.84%)
         occurrences all number
    2
    2
    2
    3
    4
    Flank pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Joint contracture
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    2 / 45 (4.44%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    4
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    1
    1
    0
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    2
    0
    0
    1
    1
    Cystitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Giardiasis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Onychomycosis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 55 (3.64%)
    3 / 45 (6.67%)
    0 / 48 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    2
    3
    0
    3
    Rhinitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 55 (0.00%)
    2 / 45 (4.44%)
    2 / 48 (4.17%)
    1 / 51 (1.96%)
         occurrences all number
    3
    0
    2
    2
    2
    Tonsillitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    COVID-19
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 55 (3.64%)
    2 / 45 (4.44%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
         occurrences all number
    1
    2
    2
    1
    2
    Asymptomatic COVID-19
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 55 (0.00%)
    8 / 45 (17.78%)
    5 / 48 (10.42%)
    1 / 51 (1.96%)
         occurrences all number
    3
    0
    8
    5
    1
    Electrolyte imbalance
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 55 (3.64%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    Hypervolaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    2
    Hyperkalaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 55 (1.82%)
    3 / 45 (6.67%)
    1 / 48 (2.08%)
    2 / 51 (3.92%)
         occurrences all number
    1
    1
    3
    1
    2
    Hypernatraemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 55 (1.82%)
    0 / 45 (0.00%)
    0 / 48 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 55 (3.64%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    16 / 48 (33.33%)
    13 / 55 (23.64%)
    4 / 45 (8.89%)
    13 / 48 (27.08%)
    13 / 51 (25.49%)
         occurrences all number
    106
    88
    28
    83
    148
    Hypophagia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    0 / 48 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 55 (0.00%)
    1 / 45 (2.22%)
    1 / 48 (2.08%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2020
    This global amendment contains revisions to the original global protocol dated (01Apr2020) to remove Cohort 2, which is no longer needed due to completion of Study D5671C00003 earlier than originally planned. Other minor revisions such as clarifications and correction of typos were made. This amendment is considered to be non-substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union because it neither significantly impacts the safety or physical/mental integrity of participants nor the scientific value of the study.
    04 Jan 2021
    This global amendment contains revisions to Amendment 1 of the global protocol dated (29Jun2020) to add time windows for specific visits to make the study more accessible to participants during the current coronavirus disease (COVID-19) pandemic. Other minor revisions such as clarifications and correction of typos were made. This amendment is considered to be non-substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union because it neither significantly impacts the safety or physical/mental integrity of participants nor the scientific value of the study.

    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
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    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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