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    Clinical Trial Results:
    A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2017-003490-33
    Trial protocol
    		 SK   GR   AT   HU   PL   ES   IT   RO  
    Global end of trial date
    10 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jun 2020
    First version publication date
    13 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H9X-MC-GBGL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03495102
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16877
    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,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.
    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
    05 Apr 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 290
    Country: Number of subjects enrolled
    Romania: 233
    Country: Number of subjects enrolled
    Hungary: 73
    Country: Number of subjects enrolled
    United States: 508
    Country: Number of subjects enrolled
    Russian Federation: 29
    Country: Number of subjects enrolled
    Spain: 58
    Country: Number of subjects enrolled
    Greece: 100
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    Poland: 167
    Country: Number of subjects enrolled
    Mexico: 111
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Slovakia: 131
    Country: Number of subjects enrolled
    Israel: 54
    Worldwide total number of subjects
    1842
    EEA total number of subjects
    800
    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)
    1404
    From 65 to 84 years
    437
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 No Text Available

    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
    		 Dulaglutide 1.5 mg
    Arm description
    		 Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    LY2189265
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Arm title
    		 Dulaglutide 3 mg
    Arm description
    		 Dulaglutide 3 mg administered SC once a week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    LY2189265
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Arm title
    		 Dulaglutide 4.5 mg
    Arm description
    		 Dulaglutide 4.5 mg administered SC once a week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dulaglutide
    Investigational medicinal product code
    Other name
    LY2189265
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Number of subjects in period 1
    		Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Started
    612
    616
    614
    Received at least one dose of study drug
    612
    616
    614
    Completed
    556
    549
    560
    Not completed
    56
    67
    54
         Adverse event, serious fatal
    3
    4
    4
         Site Closure
    3
    1
    2
         Physician decision
    2
    -
    2
         Consent withdrawn by subject
    25
    36
    18
         Primary Care Physician Recommendation
    -
    1
    -
         Adverse event, non-fatal
    5
    7
    10
         Non-compliance
    1
    -
    -
         Relocated to Another Country
    -
    1
    -
         Participant Duplicated at Another Site
    -
    -
    1
         Lost to follow-up
    15
    16
    17
         Participant was in Rehabilitation
    1
    -
    -
         Protocol deviation
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.

    Reporting group title
    Dulaglutide 3 mg
    Reporting group description
    		 Dulaglutide 3 mg administered SC once a week.

    Reporting group title
    Dulaglutide 4.5 mg
    Reporting group description
    		 Dulaglutide 4.5 mg administered SC once a week.

    Reporting group values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg Total
    Number of subjects
    		 612 616 614 1842
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.8 ( 9.7 ) 56.9 ( 10.2 ) 56.6 ( 10.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 314 288 296 898
        Male
    		 298 328 318 944
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 30 26 32 88
        Asian
    		 13 18 14 45
        Native Hawaiian or Other Pacific Islander
    		 1 1 3 5
        Black or African American
    		 28 31 23 82
        White
    		 529 521 530 1580
        More than one race
    		 11 19 12 42
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Argentina
    		 96 97 97 290
        Romania
    		 77 78 78 233
        Hungary
    		 25 24 24 73
        United States
    		 169 169 170 508
        Russia
    		 9 10 10 29
        Spain
    		 19 20 19 58
        Greece
    		 33 34 33 100
        Canada
    		 12 11 12 35
        Austria
    		 4 4 5 13
        Taiwan
    		 5 5 5 15
        Poland
    		 56 56 55 167
        Mexico
    		 37 38 36 111
        Italy
    		 9 8 8 25
        Slovakia
    		 43 44 44 131
        Israel
    		 18 18 18 54
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 214 214 213 641
        Not Hispanic or Latino
    		 369 363 371 1103
        Unknown or Not Reported
    		 29 39 30 98
    Hemoglobin A1C (HbA1c) at Baseline
    HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 8.64 ( 0.94 ) 8.63 ( 1.00 ) 8.64 ( 0.91 ) -

    End points

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    End points reporting groups
    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.

    Reporting group title
    Dulaglutide 3 mg
    Reporting group description
    		 Dulaglutide 3 mg administered SC once a week.

    Reporting group title
    Dulaglutide 4.5 mg
    Reporting group description
    		 Dulaglutide 4.5 mg administered SC once a week.

    Primary: Change in Hemoglobin A1c (HbA1c) from Baseline

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    End point title
    		 Change in Hemoglobin A1c (HbA1c) from Baseline
    End point description
    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). Analysis Population Description: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
    End point type
    Primary
    End point timeframe
    Baseline, Week 36
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    523
    521
    526
    Units: Percentage of HbA1c
        least squares mean (standard error)
    -1.53 ( 0.04 )
    -1.71 ( 0.04 )
    -1.87 ( 0.04 )
    Statistical analysis title
    		 Change in Hemoglobin A1c (HbA1c) from Baseline
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 3 mg
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 -0.06
    Statistical analysis title
    		 Change in Hemoglobin A1c (HbA1c) from Baseline
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 4.5 mg
    Number of subjects included in analysis
    1049
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.22

    Secondary: Change in Body Weight from Baseline

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    End point title
    		 Change in Body Weight from Baseline
    End point description
    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). Analysis Population Description: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline body weight value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 36
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    522
    520
    526
    Units: Kilograms (Kg)
        least squares mean (standard deviation)
    -3.1 ( 0.19 )
    -4.0 ( 0.19 )
    -4.7 ( 0.19 )
    Statistical analysis title
    		 Change in Body Weight from Baseline
    Comparison groups
    Dulaglutide 3 mg v Dulaglutide 1.5 mg
    Number of subjects included in analysis
    1042
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.4
    Statistical analysis title
    		 Change in Body Weight from Baseline
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 4.5 mg
    Number of subjects included in analysis
    1048
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -1.1

    Secondary: Percentage of Participants Achieving HbA1c Target <7.0%

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    End point title
    		 Percentage of Participants Achieving HbA1c Target <7.0%
    End point description
    Percentage of participants achieving HbA1c target <7.0%. Analysis Population Description: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    523
    521
    526
    Units: percentage of participants
        number (not applicable)
    56.98
    64.68
    71.48
    Statistical analysis title
    		 Participants Achieving HbA1c Target <7.0%
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 3 mg
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.98
    Statistical analysis title
    		 Participants Achieving HbA1c Target <7.0%
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 4.5 mg
    Number of subjects included in analysis
    1049
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.65
         upper limit
    		 3.01

    Secondary: Change in Fasting Serum Glucose (FSG) from Baseline

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    End point title
    		 Change in Fasting Serum Glucose (FSG) from Baseline
    End point description
    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). Analysis Population Description: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline FSG value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 36
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    510
    509
    514
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    -44.2 ( 1.50 )
    -47.9 ( 1.50 )
    -52.3 ( 1.50 )
    Statistical analysis title
    		 Change in FSG From Baseline
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 3 mg
    Number of subjects included in analysis
    1019
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 0.5
    Statistical analysis title
    		 Change in FSG From Baseline
    Comparison groups
    Dulaglutide 1.5 mg v Dulaglutide 4.5 mg
    Number of subjects included in analysis
    1024
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.3
         upper limit
    		 -3.9

    Secondary: Rate of Documented Symptomatic Hypoglycemic Episodes

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    End point title
    		 Rate of Documented Symptomatic Hypoglycemic Episodes
    End point description
    Hypoglycemia was defined as blood glucose < 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean (Least Squares Mean was selected from the dropdown list because there is no Group Mean option) from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    612
    616
    614
    Units: Episodes/participant/365.25 days
        least squares mean (standard error)
    0.02 ( 0.01 )
    0.00 ( 0.00 )
    0.02 ( 0.01 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)

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    End point title
    		 Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)
    End point description
    Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss). Analysis Population Description: All participants who received at least one dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 12, Week 36, Week 52, Week 56
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    612
    616
    614
    Units: nanogram/milliliter (ng/mL)
        arithmetic mean (confidence interval 90%)
    79.6 (77.7 to 81.7)
    159 (155 to 163)
    238 (232 to 243)
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State

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    End point title
    		 Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State
    End point description
    Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State. All participants who received at least one dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 12, Week 36, Week 52, Week 56
    End point values
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Number of subjects analysed
    612
    616
    614
    Units: nanogram*hour/milliliter (ng*h/mL)
        arithmetic mean (confidence interval 90%)
    11200 (10900 to 11500)
    22300 (21800 to 22900)
    33400 (32700 to 34200)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 56
    Adverse event reporting additional description
    All participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Dulaglutide 1.5 mg
    Reporting group description
    		 Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.

    Reporting group title
    Dulaglutide 3 mg
    Reporting group description
    		 Dulaglutide 3 mg administered SC once a week.

    Reporting group title
    Dulaglutide 4.5 mg
    Reporting group description
    		 Dulaglutide 4.5 mg administered SC once a week.

    Serious adverse events
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    53 / 612 (8.66%)
    45 / 616 (7.31%)
    38 / 614 (6.19%)
         number of deaths (all causes)
    3
    4
    4
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenocarcinoma pancreas
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    bladder cancer recurrent
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    clear cell renal cell carcinoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    metastases to abdominal cavity
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    metastatic uterine cancer
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [1]
    1 / 314 (0.32%)
    0 / 288 (0.00%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    neuroendocrine tumour
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    papillary thyroid cancer
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    phaeochromocytoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    plasma cell myeloma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [2]
    1 / 298 (0.34%)
    0 / 328 (0.00%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    uterine leiomyoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [3]
    1 / 314 (0.32%)
    0 / 288 (0.00%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    arteriosclerosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypertensive emergency
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    cholecystectomy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [4]
    0 / 314 (0.00%)
    2 / 288 (0.69%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    death
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    medical device site joint inflammation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 612 (0.33%)
    1 / 616 (0.16%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    2 / 614 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    Reproductive system and breast disorders
    cervical polyp
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [5]
    0 / 314 (0.00%)
    1 / 288 (0.35%)
    0 / 296 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    oedema genital
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ovarian cyst
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [6]
    0 / 314 (0.00%)
    0 / 288 (0.00%)
    1 / 296 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 616 (0.32%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypersensitivity pneumonitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nasal polyps
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nasal septum deviation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    major depression
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    panic attack
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    stress
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    amylase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ecg signs of myocardial ischaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    electrocardiogram t wave inversion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lipase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 612 (0.33%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    alcohol poisoning
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    comminuted fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    exposure to toxic agent
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    femoral neck fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    fibula fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hand fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    humerus fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    limb traumatic amputation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    post procedural haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 616 (0.32%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 612 (0.49%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    atrioventricular block complete
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    atrioventricular block second degree
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    congestive cardiomyopathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    left ventricular failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    2 / 616 (0.32%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    balance disorder
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cerebral artery occlusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diabetic mononeuropathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 616 (0.32%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    loss of consciousness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neuralgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    wernicke's encephalopathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    blood loss anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    acute vestibular syndrome
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    vertigo
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    eyelid oedema
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    2 / 614 (0.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    abdominal pain upper
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastric polyps
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    haematochezia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    haemorrhoids
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hiatus hernia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    mesenteric vein thrombosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    obstructive pancreatitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis acute
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    2 / 616 (0.32%)
    2 / 614 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hepatic cirrhosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    jaundice
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    jaundice cholestatic
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    portal vein thrombosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    angioedema
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    rash maculo-papular
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    goitre
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    osteoarthropathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    plica syndrome
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abscess limb
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    abscess neck
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    campylobacter infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cholecystitis infective
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    chronic sinusitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infective exacerbation of chronic obstructive airways disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    perinephric abscess
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    periorbital cellulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 612 (0.33%)
    2 / 616 (0.32%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pyoderma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    renal abscess
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    west nile viral infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 612 (0.16%)
    0 / 616 (0.00%)
    1 / 614 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 612 (0.00%)
    1 / 616 (0.16%)
    0 / 614 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [5] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [6] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dulaglutide 1.5 mg Dulaglutide 3 mg Dulaglutide 4.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    156 / 612 (25.49%)
    190 / 616 (30.84%)
    195 / 614 (31.76%)
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    48 / 612 (7.84%)
    75 / 616 (12.18%)
    70 / 614 (11.40%)
         occurrences all number
    83
    118
    176
    dyspepsia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    17 / 612 (2.78%)
    33 / 616 (5.36%)
    18 / 614 (2.93%)
         occurrences all number
    26
    56
    35
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    87 / 612 (14.22%)
    99 / 616 (16.07%)
    106 / 614 (17.26%)
         occurrences all number
    121
    180
    192
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    40 / 612 (6.54%)
    57 / 616 (9.25%)
    64 / 614 (10.42%)
         occurrences all number
    63
    89
    108
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    29 / 612 (4.74%)
    33 / 616 (5.36%)
    39 / 614 (6.35%)
         occurrences all number
    38
    41
    48

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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