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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH)

    Summary
    EudraCT number
    		 2019-001550-26
    Trial protocol
    		 GB   BE   FR   ES   IT  
    Global end of trial date
    10 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2024
    First version publication date
    25 Dec 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I8F-MC-GPHR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04166773
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17361
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly, EU_Lilly_Clinical_Trials@lilly.com
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly, EU_Lilly_Clinical_Trials@lilly.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
    10 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that Tirzepatide 5 milligram (mg), 10mg or 15mg administered subcutaneously (SC) once a week (QW) is superior to placebo for NASH resolution with no worsening of fibrosis at Week 52.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    France: 22
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Japan: 16
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    United States: 107
    Worldwide total number of subjects
    190
    EEA total number of subjects
    38
    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)
    153
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not Applicable

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5 mg Tirzepatide
    Arm description
    		 Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks then 5 mg tirzepatide SC QW from week 5-52].

    Arm title
    		 10 mg Tirzepatide
    Arm description
    		 Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].

    Arm title
    		 15 mg Tirzepatide
    Arm description
    		 Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg every 4 weeks until target dose (15 mg) was reached].

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo administered SC QW for 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo administered SC QW for 52 weeks.

    Number of subjects in period 1
    		5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Started
    47
    47
    48
    48
    Received at Least One Dose of Study Drug
    47
    47
    48
    48
    Completed
    40
    44
    43
    38
    Not completed
    7
    3
    5
    10
         Consent withdrawn by subject
    1
    1
    2
    5
         Physician decision
    -
    -
    -
    1
         Adverse event, non-fatal
    2
    -
    2
    1
         Lost to follow-up
    4
    2
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5 mg Tirzepatide
    Reporting group description
    		 Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].

    Reporting group title
    10 mg Tirzepatide
    Reporting group description
    		 Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].

    Reporting group title
    15 mg Tirzepatide
    Reporting group description
    		 Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered SC QW for 52 weeks.

    Reporting group values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo Total
    Number of subjects
    		 47 47 48 48 190
    Age categorical
    All randomized participants.
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 37 38 41 37 153
        From 65-84 years
    		 10 9 7 11 37
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    All randomized participants.
    Units: Subjects
        Female
    		 27 26 29 27 109
        Male
    		 20 21 19 21 81
    Ethnicity (NIH/OMB)
    All randomized participants.
    Units: Subjects
        Hispanic or Latino
    		 19 15 17 18 69
        Not Hispanic or Latino
    		 21 25 27 24 97
        Unknown or Not Reported
    		 7 7 4 6 24
    Race (NIH/OMB)
    All randomized participants.
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 1 0 3
        Asian
    		 5 6 6 5 22
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 1 0 0 1
        White
    		 41 39 41 43 164
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Region of Enrollment
    All randomized participants.
    Units: Subjects
        Belgium
    		 0 0 1 0 1
        France
    		 7 7 2 6 22
        Israel
    		 3 2 0 0 5
        Italy
    		 1 0 2 3 6
        Japan
    		 4 4 4 4 16
        Mexico
    		 1 3 3 3 10
        Poland
    		 1 0 0 0 1
        Spain
    		 1 0 6 1 8
        United Kingdom
    		 1 5 4 4 14
        United States
    		 28 26 26 27 107

    End points

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    End points reporting groups
    Reporting group title
    5 mg Tirzepatide
    Reporting group description
    		 Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52].

    Reporting group title
    10 mg Tirzepatide
    Reporting group description
    		 Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached].

    Reporting group title
    15 mg Tirzepatide
    Reporting group description
    		 Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached].

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered SC QW for 52 weeks.

    Primary: Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology

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    End point title
    		 Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology
    End point description
    NASH resolution is defined as the absence of fatty liver disease or simple steatosis without steatohepatitis; the absence of hepatocellular ballooning (nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) 0 for ballooning); with or without mild lobular inflammation (NAS 0 or 1 for inflammation); and any value for steatosis. No worsening of fibrosis is defined as no increase in fibrosis stage from baseline to Week 52. Analysis population description: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
    End point type
    Primary
    End point timeframe
    Week 52
    End point values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Number of subjects analysed
    39
    41
    40
    35
    Units: percentage of participants
        number (not applicable)
    51.84
    63.13
    73.92
    12.62
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    5 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    7.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.27
         upper limit
    		 24.44
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    10 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    11.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.59
         upper limit
    		 39.11
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    15 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    19.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.73
         upper limit
    		 67.25

    Secondary: Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology

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    End point title
    		 Percentage of Participants With ≥1 Point Decrease in Fibrosis Stage With No Worsening of NASH on Liver Histology
    End point description
    NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Participants were evaluated with the NASH CRN scoring system with ≥1-point reduction without worsening of NASH (defined as no increase in the NAS score). APD: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Number of subjects analysed
    39
    41
    40
    35
    Units: percentage of participants
        number (not applicable)
    59.21
    53.35
    54.3
    32.51
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    5 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 7.9
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors
    Comparison groups
    10 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.074
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 6.13
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    15 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.063
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 6.4

    Secondary: Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology

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    End point title
    		 Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology
    End point description
    Participants were evaluated with the NASH CRN scoring system with ≥1 stage increase in fibrosis. APD: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Number of subjects analysed
    39
    41
    40
    35
    Units: percentage of participants
        number (not applicable)
    12.04
    9.81
    5.53
    13.03
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    5 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.893
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 3.4
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    10 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.647
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 2.87
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    15 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.246
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 1.91

    Secondary: Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components

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    End point title
    		 Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components
    End point description
    Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in at least 2 NAS components (lobular inflammation, hepatocellular ballooning or steatosis). The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8, with the higher score indicating more aggressive disease. APD: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Number of subjects analysed
    39
    41
    40
    35
    Units: percentage of participants
        number (not applicable)
    81.02
    86.55
    88.77
    38.09
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    5 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    74
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    6.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.41
         upper limit
    		 20
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    10 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    10.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.36
         upper limit
    		 32.61
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.
    Comparison groups
    15 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    12.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.87
         upper limit
    		 42.65

    Secondary: Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF)

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    End point title
    		 Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF)
    End point description
    MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. Least square (LS) mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured. APD: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Number of subjects analysed
    28
    33
    32
    27
    Units: change of whole liver fat
        least squares mean (standard error)
    -10.12 ( 1.165 )
    -10.15 ( 1.071 )
    -11.34 ( 1.107 )
    -1.31 ( 1.142 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    5 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -8.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.04
         upper limit
    		 -5.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.632
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    10 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -8.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.93
         upper limit
    		 -5.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.566
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    15 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -10.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.17
         upper limit
    		 -6.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.591

    Secondary: Mean Change From Baseline in Body Weight

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    End point title
    		 Mean Change From Baseline in Body Weight
    End point description
    Change in body weight at the end of 52 weeks measured in kilogram (kg) using a calibrated scale. LS mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured. APD: All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 52
    End point values
    		 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Placebo
    Number of subjects analysed
    40
    42
    42
    37
    Units: kilogram (kg)
        least squares mean (standard error)
    -11.46 ( 1.404 )
    -14.22 ( 1.380 )
    -17.88 ( 1.376 )
    -1.04 ( 1.392 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    5 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -10.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.32
         upper limit
    		 -6.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.976
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    10 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -13.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.05
         upper limit
    		 -9.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.96
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    15 mg Tirzepatide v Placebo
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -16.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.71
         upper limit
    		 -12.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.957

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up to Week 56
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    5 mg Tirzepatide
    Reporting group description
    		 Participants received 5 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks then 5 mg tirzepatide SC QW from weeks 5-52].

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo administered SC QW for 52 weeks.

    Reporting group title
    15 mg Tirzepatide
    Reporting group description
    		 Participants received 15 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg every 4 weeks until target dose (15 mg) was reached].

    Reporting group title
    10 mg Tirzepatide
    Reporting group description
    		 Participants received 10 mg tirzepatide administered SC QW for 52 weeks [initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg and 10 mg every 4 weeks until target dose (10 mg) was reached].

    Serious adverse events
    		 5 mg Tirzepatide Placebo 15 mg Tirzepatide 10 mg Tirzepatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 47 (10.64%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    4 / 47 (8.51%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ovarian neoplasm
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [1]
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 29 (0.00%)
    0 / 26 (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
    Congenital, familial and genetic disorders
    developmental hip dysplasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (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
    phlebitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (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
    Nervous system disorders
    transient ischaemic attack
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (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
    Reproductive system and breast disorders
    endometrial thickening
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [2]
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 29 (0.00%)
    0 / 26 (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 disorders
    large intestine polyp
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         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
    rectal haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumoperitoneum
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         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
    umbilical hernia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         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
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         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
    Renal and urinary disorders
    ureterolithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (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
    rhabdomyolysis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (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
    Infections and infestations
    bacteraemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (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
    covid-19 pneumonia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (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
    Metabolism and nutrition disorders
    hypokalaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 5 mg Tirzepatide Placebo 15 mg Tirzepatide 10 mg Tirzepatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 47 (91.49%)
    40 / 48 (83.33%)
    44 / 48 (91.67%)
    43 / 47 (91.49%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    basal cell carcinoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    colorectal adenoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hepatic adenoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    meningioma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    ovarian neoplasm
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [3]
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    skin papilloma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    hot flush
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    hypertension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    0
    0
    3
    hypotension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    orthostatic hypotension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    0
    peripheral coldness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    raynaud's phenomenon
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    cyst removal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    eyelid cyst removal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gastrointestinal endoscopic therapy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    hip arthroplasty
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    knee arthroplasty
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    large intestinal polypectomy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    2
    nail operation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    skin neoplasm excision
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    tendon sheath incision
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tooth extraction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    uterine polypectomy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [4]
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    4 / 47 (8.51%)
         occurrences all number
    3
    2
    0
    6
    chest discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    4
    0
    energy increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    fatigue
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 48 (6.25%)
    5 / 48 (10.42%)
    4 / 47 (8.51%)
         occurrences all number
    5
    4
    5
    5
    injection site bruising
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    injection site erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    2
    1
    injection site inflammation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    injection site rash
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    injection site reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    1 / 47 (2.13%)
         occurrences all number
    5
    0
    10
    2
    injection site swelling
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    malaise
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    2
    1
    1
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    oedema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    oedema peripheral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    2
    3
    0
    1
    pyrexia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    1
    1
    thirst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    vaccination site pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    drug hypersensitivity
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    hypersensitivity
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    seasonal allergy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [5]
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    breast cyst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    breast discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    intermenstrual bleeding
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [6]
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    testicular pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [7]
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [8]
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vulvovaginal discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [9]
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 29 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    cough
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    3 / 48 (6.25%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    3
    1
    dyspnoea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    nasal congestion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    1
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    0
    1
    depression
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    insomnia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    1
    0
    major depression
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    0
    1
    amylase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    1
    1
    bacterial test positive
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    blood glucose abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    blood glucose decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    biopsy liver
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    haematocrit abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    haemoglobin abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    lipase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
    1 / 47 (2.13%)
         occurrences all number
    3
    0
    4
    1
    pancreatic enzymes increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    sars-cov-2 test positive
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    1
    1
    urine albumin/creatinine ratio increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    weight decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 47 (10.64%)
    0 / 48 (0.00%)
    4 / 48 (8.33%)
    3 / 47 (6.38%)
         occurrences all number
    5
    0
    4
    3
    Injury, poisoning and procedural complications
    animal bite
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    epicondylitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    exposure to toxic agent
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    3
    fibula fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    fall
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    1
    1
    immunisation reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    ligament sprain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    0
    2
    joint injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    meniscus injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    muscle strain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    0
    2
    procedural pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    1
    3
    0
    2
    post procedural bile leak
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    post procedural fever
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    post vaccination syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    procedural nausea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    rib fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    skin abrasion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    skin laceration
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    2
    0
    spinal compression fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    stoma site haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    tooth fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    thermal burn
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital, familial and genetic disorders
    gilbert's syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    atrial tachycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    bradycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    cardiac failure
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    palpitations
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    1
    0
    0
    sinus bradycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    tachycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    Nervous system disorders
    aphasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    disturbance in attention
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    dizziness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 48 (4.17%)
    4 / 48 (8.33%)
    6 / 47 (12.77%)
         occurrences all number
    2
    2
    4
    7
    dysgeusia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    1
    1
    0
    2
    headache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 47 (6.38%)
    5 / 48 (10.42%)
    3 / 48 (6.25%)
    6 / 47 (12.77%)
         occurrences all number
    3
    5
    4
    7
    hypoaesthesia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    0
    0
    lethargy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    lumbar radiculopathy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    migraine
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    17
    2
    1
    0
    neuralgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    neuritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    paraesthesia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    0
    presyncope
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    sciatica
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    1
    0
    radiculopathy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    syncope
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    somnolence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    taste disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    3 / 47 (6.38%)
         occurrences all number
    0
    0
    1
    3
    tension headache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    tremor
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    thrombocytopenia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    tinnitus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    vertigo
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    3
    0
    0
    conjunctivitis allergic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    0
    1
    eye pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    meibomian gland dysfunction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    vision blurred
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    visual acuity reduced
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    4 / 47 (8.51%)
         occurrences all number
    1
    0
    0
    6
    abdominal distension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 48 (8.33%)
    6 / 48 (12.50%)
    3 / 47 (6.38%)
         occurrences all number
    3
    4
    8
    3
    abdominal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    6 / 47 (12.77%)
    3 / 48 (6.25%)
    4 / 48 (8.33%)
    3 / 47 (6.38%)
         occurrences all number
    12
    3
    7
    4
    abdominal pain lower
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    6 / 47 (12.77%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    10
    2
    0
    2
    anal fissure
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    anal incontinence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    bowel movement irregularity
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    breath odour
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    change of bowel habit
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    colonic angioectasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    constipation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    11 / 47 (23.40%)
    3 / 48 (6.25%)
    7 / 48 (14.58%)
    9 / 47 (19.15%)
         occurrences all number
    12
    4
    8
    12
    diverticulum
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    diarrhoea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    15 / 47 (31.91%)
    11 / 48 (22.92%)
    13 / 48 (27.08%)
    17 / 47 (36.17%)
         occurrences all number
    17
    14
    20
    40
    dry mouth
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 48 (6.25%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    1
    3
    1
    1
    duodenitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    dysphagia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dyspepsia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 48 (4.17%)
    2 / 48 (4.17%)
    8 / 47 (17.02%)
         occurrences all number
    3
    2
    2
    11
    eructation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    4 / 48 (8.33%)
    2 / 47 (4.26%)
         occurrences all number
    1
    0
    5
    2
    gastric ulcer
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    flatulence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    3 / 48 (6.25%)
    3 / 47 (6.38%)
         occurrences all number
    2
    1
    4
    3
    haemorrhoids
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    gastritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    1
    0
    gastrointestinal disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    gastrointestinal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    4 / 48 (8.33%)
    3 / 47 (6.38%)
         occurrences all number
    2
    0
    5
    5
    gingival bleeding
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    inguinal hernia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    1
    1
    large intestine polyp
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    1
    1
    nausea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    17 / 47 (36.17%)
    6 / 48 (12.50%)
    21 / 48 (43.75%)
    16 / 47 (34.04%)
         occurrences all number
    69
    7
    26
    33
    oesophagitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    1
    2
    pancreatitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    rectal haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    1
    1
    small intestinal obstruction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    toothache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    tooth loss
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 48 (2.08%)
    7 / 48 (14.58%)
    3 / 47 (6.38%)
         occurrences all number
    3
    1
    14
    5
    Hepatobiliary disorders
    biliary colic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    cholangitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    cholelithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    1
    0
    1
    hepatic cirrhosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    2
    1
    0
    2
    hepatic fibrosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    hepatic haematoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hypertransaminasaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
    2 / 47 (4.26%)
         occurrences all number
    4
    0
    5
    2
    blister
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    dermatitis contact
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    ecchymosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    eczema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    2
    intertrigo
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    koilonychia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    photosensitivity reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    pruritus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    1
    2
    1
    0
    rash
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    2
    0
    1
    skin hyperpigmentation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    urticaria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Renal and urinary disorders
    dysuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    0
    1
    microalbuminuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    micturition urgency
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    nephrolithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    renal failure
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    renal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    ureterolithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    urinary incontinence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    urine odour abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    hypothyroidism
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    thyroid mass
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 47 (10.64%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
    2 / 47 (4.26%)
         occurrences all number
    5
    1
    2
    2
    back pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 48 (4.17%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    3
    3
    1
    1
    bursitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    exostosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    greater trochanteric pain syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    immune-mediated myositis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    joint swelling
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    limb discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    muscle spasms
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    3
    0
    0
    1
    myalgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    neck pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    osteoarthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    2
    0
    0
    1
    osteochondritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    osteopenia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    2 / 47 (4.26%)
         occurrences all number
    2
    1
    1
    2
    osteoporosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    rhabdomyolysis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    rheumatic disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    0
    0
    0
    sacral pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    spinal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    systemic lupus erythematosus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    tendonitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    1
    0
    0
    1
    Infections and infestations
    acute sinusitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    bacterial vaginosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [10]
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 29 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    2
    3
    0
    0
    covid-19
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 47 (10.64%)
    4 / 48 (8.33%)
    9 / 48 (18.75%)
    6 / 47 (12.77%)
         occurrences all number
    6
    5
    9
    6
    cellulitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    conjunctivitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    1
    0
    2
    cystitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    folliculitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    1
    0
    0
    fungal infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    hand-foot-and-mouth disease
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    gastroenteritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    helicobacter infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    2 / 48 (4.17%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    2
    0
    herpes virus infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    herpes zoster
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    1
    1
    helicobacter gastritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    infected bite
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    2 / 47 (4.26%)
         occurrences all number
    0
    0
    0
    2
    lower respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 47 (0.00%)
         occurrences all number
    0
    0
    1
    0
    onychomycosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 48 (2.08%)
    2 / 48 (4.17%)
    1 / 47 (2.13%)
         occurrences all number
    1
    1
    2
    1
    oral fungal infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    otitis media
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    paronychia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    sinusitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 48 (2.08%)
    1 / 48 (2.08%)
    1 / 47 (2.13%)
         occurrences all number
    2
    1
    1
    2
    tooth infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    2
    0
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    3 / 47 (6.38%)
         occurrences all number
    2
    0
    1
    3
    urinary tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 48 (8.33%)
    2 / 48 (4.17%)
    3 / 47 (6.38%)
         occurrences all number
    2
    4
    2
    4
    viral rhinitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [11]
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 29 (3.45%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [12]
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 29 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    9 / 47 (19.15%)
    1 / 48 (2.08%)
    11 / 48 (22.92%)
    10 / 47 (21.28%)
         occurrences all number
    9
    1
    12
    12
    diabetes mellitus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    diabetes mellitus inadequate control
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    dyslipidaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    glucose tolerance impaired
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    hypercholesterolaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    0
    0
    1
    hyperglycaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    1 / 47 (2.13%)
         occurrences all number
    0
    3
    0
    1
    hyperkalaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hyperuricaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    1
    0
    0
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    3
    0
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    0 / 47 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Notes
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Aug 2019
    -Updated contraceptive information in Inclusion criteria; - Corrected visit window for Schedule of Activities
    21 Oct 2019
    - Modified Schedule of Activities; - Added wording to clarify end of study; - Inclusion and Exclusion Criteria were modified; - Explained purpose of stratification to Minimize Bias: Randomization and Blinding; - Updated Concomitant medication, Hyperglycemia rescue medication, vital signs; - Added patient discontinuation criteria based on TEAE and SAE severity and relatedness; -Added information on duration of storage of liver biopsy tissue blocks and slides; - Reduced the time for follow up liver testing; -Corrected blood glucose values; -Clarified the interim analyses; -Outlined safety reviews based on Lilly Standard Operating Procedures (SOPs); - Added study discontinuation criteria based on TEAE and SAE severity and relatedness; - Moved calcitonin to special laboratory tests; -Added text on additional liver tests
    15 Nov 2019
    - Overall Design, primary efficacy assessment, baseline liver biopsy changed from 3 to 6 months; -Inclusion Criteria, Liver Safety: Actions and Follow- Up assessments, Supporting documentation and operational considerations were modified
    19 Nov 2020
    - Schedule of Activities and Inclusion criteria were modified; - Added description of the FibroScan-(aspartate aminotransferase [AST]) (FAST) score; -Populations for analyses were modified; - Replaced full analysis set (FAS) with safety analysis set (SS) in safety analyses; - Added procedures in provisions for changes in study conduct during exceptional circumstances

    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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