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    Clinical Trial Results:
    An Individualized treatMent aPproach for oldER patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM)

    Summary
    EudraCT number
    		 2013-001473-24
    Trial protocol
    		 GB   DE   AT  
    Global end of trial date
    14 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2016
    First version publication date
    20 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14842
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02072096
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial ID: 14842, Trial Alias: F3Z-MC-IOQL
    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
    14 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with type 2 diabetes Mellitus (T2DM). One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.
    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
    26 Feb 2014
    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
    United Kingdom: 21
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Austria: 32
    Country: Number of subjects enrolled
    Puerto Rico: 39
    Country: Number of subjects enrolled
    United States: 64
    Worldwide total number of subjects
    192
    EEA total number of subjects
    89
    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)
    0
    From 65 to 84 years
    189
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All participants completed the first 24 weeks of the study at which time interim analysis was triggered to assess feasibility.The study was terminated after the interim analysis. Some participants continued into the Core study but discontinued at the next office study visit. Data was assessed from Baseline to last participant visit, up to 72 week

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Strategy A (Glucose-Dependent)
    Arm description
    		 Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks. Metformin: Administered orally Pioglitazone: Administered orally Acarbose: Administered orally Linagliptin: Administered orally Sitagliptin: Administered orally Liraglutide: Administered subcutaneous (SC) Exenatide once weekly (QW): Administered SC Exenatide twice daily (BID): Administered SC
    Arm type
    		 Experimental

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin Administered orally every day.

    Investigational medicinal product name
    Pioglitazone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pioglitazone administered orally every day.

    Investigational medicinal product name
    Acarbose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Acarbose administered orally every day

    Investigational medicinal product name
    Linagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Linagliptin administered orally every day.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin administered orally daily.

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide administered subcutaneous (SC) daily.

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide once weekly administered SC.

    Investigational medicinal product name
    Exenatide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Exenatide twice daily administered SC.

    Arm title
    		 Strategy B (Reference)
    Arm description
    		 Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks. Glimepiride: Administered orally Metformin: Administered orally Pioglitazone: Administered orally Acarbose: Administered orally Linagliptin: Administered orally Sitagliptin: Administered orally Insulin Glargine: Administered SC
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride administered orally every day.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin administered orally every day.

    Investigational medicinal product name
    Pioglitazone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pioglitazone administered orally every day.

    Investigational medicinal product name
    Acarbose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Acarbose administered orally every day.

    Investigational medicinal product name
    Linagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Linagliptin administered orally every day.

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin administered orally every day.

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Glargine administered subcutaneous every day.

    Number of subjects in period 1
    		Strategy A (Glucose-Dependent) Strategy B (Reference)
    Started
    99
    93
    Received at least one dose of study drug
    98
    93
    Completed
    14
    15
    Not completed
    85
    78
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    5
    7
         Physician decision
    -
    1
         Adverse event, non-fatal
    5
    2
         No Reason Provided
    4
    2
         Study Terminated by Sponsor
    43
    30
         Lost to follow-up
    1
    -
         Lack of efficacy
    18
    29
         Protocol deviation
    7
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Strategy A (Glucose-Dependent)
    Reporting group description
    		 Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks. Metformin: Administered orally Pioglitazone: Administered orally Acarbose: Administered orally Linagliptin: Administered orally Sitagliptin: Administered orally Liraglutide: Administered subcutaneous (SC) Exenatide once weekly (QW): Administered SC Exenatide twice daily (BID): Administered SC

    Reporting group title
    Strategy B (Reference)
    Reporting group description
    		 Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks. Glimepiride: Administered orally Metformin: Administered orally Pioglitazone: Administered orally Acarbose: Administered orally Linagliptin: Administered orally Sitagliptin: Administered orally Insulin Glargine: Administered SC

    Reporting group values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference) Total
    Number of subjects
    		 99 93 192
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 96 93 189
        85 years and over
    		 3 0 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.7 ( 5.3 ) 70.7 ( 4.4 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 43 34 77
        Male
    		 56 59 115
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 35 32 67
        Not Hispanic or Latino
    		 63 59 122
        Unknown or Not Reported
    		 1 2 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 6 10 16
        White
    		 93 81 174
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Austria
    		 18 14 32
        Puerto Rico
    		 23 16 39
        United States
    		 29 35 64
        United Kingdom
    		 10 11 21
        Germany
    		 19 17 36

    End points

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    End points reporting groups
    Reporting group title
    Strategy A (Glucose-Dependent)
    Reporting group description
    		 Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks. Metformin: Administered orally Pioglitazone: Administered orally Acarbose: Administered orally Linagliptin: Administered orally Sitagliptin: Administered orally Liraglutide: Administered subcutaneous (SC) Exenatide once weekly (QW): Administered SC Exenatide twice daily (BID): Administered SC

    Reporting group title
    Strategy B (Reference)
    Reporting group description
    		 Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks. Glimepiride: Administered orally Metformin: Administered orally Pioglitazone: Administered orally Acarbose: Administered orally Linagliptin: Administered orally Sitagliptin: Administered orally Insulin Glargine: Administered SC

    Primary: Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia

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    End point title
    		 Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia
    End point description
    Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c > upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c > upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose <3.0 mmol/L. Success is defined as lacking of failure.
    End point type
    Primary
    End point timeframe
    Baseline to last participant visit (up to 72 weeks)
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    98 [1]
    93 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    64.5 (54.4 to 73.4)
    54.9 (44.6 to 64.9)
    Notes
    [1] - All participants who received at least one dose of study drug.
    [2] - All participants who received at least one dose of study drug.
    Statistical analysis title
    		 Achieving and Maintaining Individualized HbA1c
    Comparison groups
    Strategy A (Glucose-Dependent) v Strategy B (Reference)
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted Proportion
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 23.2

    Secondary: Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy

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    End point title
    		 Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to last participant visit (up to 72 weeks)
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    98 [3]
    93 [4]
    Units: percentage of participants
        number (not applicable)
    21
    13
    Notes
    [3] - All participants who received at least one dose of study drug.
    [4] - All participants who received at least one dose of study drug.
    No statistical analyses for this end point

    Secondary: Number of Participants with Total Hypoglycemia and Other Categories of Hypoglycemia

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    End point title
    		 Number of Participants with Total Hypoglycemia and Other Categories of Hypoglycemia
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to last participant visit (up to 72 weeks)
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    98 [5]
    93
    Units: Participants
    number (not applicable)
        Total Hypoglycemia
    10
    50
        Severe Hypoglycemia
    0
    0
        Clinically Significant Hypoglycemia
    0
    1
        Symptomatic Hypoglycemia
    5
    34
        Asymptomatic Hypoglycemia
    8
    30
        Probable Symptomatic Hypoglycemia
    0
    7
        Unspecified Hypoglycemia
    2
    7
        Relative Hypoglycemia
    1
    6
        Nocturnal Hypoglycemia
    4
    10
    Notes
    [5] - All participants who received at least one dose of study drug.
    No statistical analyses for this end point

    Secondary: Change from Baseline of Urinary Albumin to Creatinine Ratio

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    End point title
    		 Change from Baseline of Urinary Albumin to Creatinine Ratio
    End point description
    The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 72
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    80 [6]
    83 [7]
    Units: milligram per millimole (mg/mmol)
        arithmetic mean (standard deviation)
    1.85 ( 22.99 )
    1.85 ( 16.46 )
    Notes
    [6] - Received 1 dose of study drug with baseline & post-baseline urinary albumin/creatinine ratio data.
    [7] - Received 1 dose of study drug with baseline & post-baseline urinary albumin/creatinine ratio data.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Mass Index (BMI)

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    End point title
    		 Change from Baseline in Body Mass Index (BMI)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 72
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    98 [8]
    93
    Units: kilogram per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    -0.47 ( 1.56 )
    0.2 ( 2.91 )
    Notes
    [8] - Participants who received 1 dose of study drug & had evaluable baseline & post-baseline BMI data.
    No statistical analyses for this end point

    Secondary: Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)

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    End point title
    		 Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)
    End point description
    The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 72
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    85 [9]
    85 [10]
    Units: millililter per minute/1.73 square meter
        arithmetic mean (standard deviation)
    -5 ( 13.64 )
    -5.88 ( 10.95 )
    Notes
    [9] - Participants who received 1 dose of study drug and had evaluable baseline & post-baseline eGFR data.
    [10] - Participants who received 1 dose of study drug and had evaluable baseline & post-baseline eGFR data.
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline in Adult Low Blood Sugar Survey (ALBSS) Score

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    End point title
    		 Change from Baseline in Adult Low Blood Sugar Survey (ALBSS) Score
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 72
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: number
        number (not applicable)
    Notes
    [11] - Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
    [12] - Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score

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    End point title
    		 Change from Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 72
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: number
        number (not applicable)
    Notes
    [13] - Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
    [14] - Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline in Mini-mental State Examination (MMSE) Score

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    End point title
    		 Change from Baseline in Mini-mental State Examination (MMSE) Score
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 72
    End point values
    		 Strategy A (Glucose-Dependent) Strategy B (Reference)
    Number of subjects analysed
    0 [15]
    0 [16]
    Units: number
        number (not applicable)
    Notes
    [15] - Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
    [16] - Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Final
    Adverse event reporting additional description
    F3Z-MC-IOQL
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Strategy A
    Reporting group description
    		 -

    Reporting group title
    Strategy B
    Reporting group description
    		 -

    Serious adverse events
    		 Strategy A Strategy B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 98 (15.31%)
    14 / 93 (15.05%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    benign neoplasm of spinal cord
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign ovarian tumour
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed [1]
    0 / 98 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatic adenoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [2]
    0 / 98 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma of lung
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    hepatic enzyme increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscle rupture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    microvascular coronary artery disease
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    carotid artery stenosis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    syncope
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    retinal vascular thrombosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastritis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis chronic
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    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.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Strategy A Strategy B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 98 (83.67%)
    74 / 93 (79.57%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    acrochordon
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    basal cell carcinoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    benign neoplasm of adrenal gland
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    colon adenoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    thyroid neoplasm
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    Vascular disorders
    arteriosclerosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    essential hypertension
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    3
    hypertension
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    5 / 98 (5.10%)
    4 / 93 (4.30%)
         occurrences all number
    5
    5
    hypotension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    peripheral vascular disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    peripheral venous disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    0
    2
    subclavian artery stenosis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    cataract operation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 93 (2.15%)
         occurrences all number
    3
    4
    coronary angioplasty
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    inguinal hernia repair
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    large intestinal polypectomy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    lens extraction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    ptosis repair
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    tendon sheath lesion excision
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    tooth extraction
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    chest pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 93 (1.08%)
         occurrences all number
    3
    1
    fatigue
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    influenza like illness
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 93 (2.15%)
         occurrences all number
    3
    2
    injection site nodule
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    malaise
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    oedema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    6 / 98 (6.12%)
    0 / 93 (0.00%)
         occurrences all number
    7
    0
    oedema peripheral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    6 / 93 (6.45%)
         occurrences all number
    1
    6
    peripheral swelling
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 93 (2.15%)
         occurrences all number
    1
    2
    pyrexia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    Immune system disorders
    hypersensitivity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    seasonal allergy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    2
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    3 / 93 (3.23%)
         occurrences all number
    1
    3
    breast mass
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    prostatitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    prostatomegaly
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    2
    cough
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 98 (4.08%)
    3 / 93 (3.23%)
         occurrences all number
    4
    5
    dry throat
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    dysphonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    dyspnoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 93 (0.00%)
         occurrences all number
    3
    0
    dyspnoea exertional
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    emphysema
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    epistaxis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    nasal congestion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    oropharyngeal pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    respiratory tract congestion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    confusional state
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    depression
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    food aversion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    insomnia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    sleep disorder
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Investigations
    arteriogram coronary
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    2
    arthroscopy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    aspiration pleural cavity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    blood glucose abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    blood glucose increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 93 (1.08%)
         occurrences all number
    2
    1
    blood pressure diastolic decreased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    blood pressure diastolic increased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    blood pressure systolic decreased
    alternative dictionary used: MedDRA 16.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    blood pressure systolic increased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    blood urea increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    blood uric acid
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    cardiac imaging procedure
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    catheterisation cardiac
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    glomerular filtration rate decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    heart rate increased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    prostatic specific antigen increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    urine analysis abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    weight decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    5 / 98 (5.10%)
    0 / 93 (0.00%)
         occurrences all number
    5
    0
    weight increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    arthropod bite
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    arthropod sting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    contusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    4 / 93 (4.30%)
         occurrences all number
    3
    5
    eye contusion
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    fall
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 93 (2.15%)
         occurrences all number
    3
    2
    foot fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    joint dislocation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    0
    2
    laceration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    4 / 93 (4.30%)
         occurrences all number
    2
    5
    ligament sprain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    limb injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    meniscus injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    post procedural haematoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    radius fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    scratch
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    skin abrasion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    spinal compression fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    type v hyperlipidaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    aortic valve stenosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    atrial fibrillation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    cardiac failure
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    left ventricular hypertrophy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    mitral valve incompetence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    palpitations
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    tachycardia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    amnesia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    autonomic neuropathy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    carotid artery stenosis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    cerebral haemorrhage
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 98 (4.08%)
    1 / 93 (1.08%)
         occurrences all number
    4
    1
    headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    7 / 98 (7.14%)
    1 / 93 (1.08%)
         occurrences all number
    14
    1
    paraesthesia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    parkinson's disease
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    polyneuropathy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    restless legs syndrome
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    sciatica
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    transient ischaemic attack
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    tremor
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    vascular encephalopathy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 93 (2.15%)
         occurrences all number
    1
    2
    iron deficiency anaemia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    lymphadenopathy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    nephrogenic anaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    cerumen impaction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    sudden hearing loss
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    diplopia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    lacrimation increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    vision blurred
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    abdominal distension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 98 (4.08%)
    0 / 93 (0.00%)
         occurrences all number
    4
    0
    abdominal pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 93 (2.15%)
         occurrences all number
    2
    2
    abdominal pain lower
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 93 (2.15%)
         occurrences all number
    3
    2
    anal pruritus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    barrett's oesophagus
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    constipation
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    dental caries
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    diarrhoea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    12 / 98 (12.24%)
    6 / 93 (6.45%)
         occurrences all number
    18
    6
    dyspepsia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    flatulence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 93 (1.08%)
         occurrences all number
    4
    1
    food poisoning
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    gastritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    gastrointestinal disorder
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 93 (2.15%)
         occurrences all number
    2
    2
    haemorrhoids
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    hiatus hernia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    impaired gastric emptying
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    large intestine polyp
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    loose tooth
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    7 / 98 (7.14%)
    3 / 93 (3.23%)
         occurrences all number
    8
    3
    toothache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 93 (1.08%)
         occurrences all number
    3
    2
    vomiting
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 93 (0.00%)
         occurrences all number
    5
    0
    Skin and subcutaneous tissue disorders
    dermatitis contact
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    0
    2
    eczema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    nail bed inflammation
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    pruritus generalised
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    urticaria contact
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    chronic kidney disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    hydronephrosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    hypertonic bladder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    microalbuminuria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    0
    2
    nephrolithiasis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    nocturia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    urinary incontinence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    goitre
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    3 / 93 (3.23%)
         occurrences all number
    2
    3
    hyperparathyroidism secondary
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    hyperthyroidism
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    hypothyroidism
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 93 (2.15%)
         occurrences all number
    1
    2
    primary hypothyroidism
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 98 (4.08%)
    4 / 93 (4.30%)
         occurrences all number
    4
    4
    back pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    9 / 98 (9.18%)
    11 / 93 (11.83%)
         occurrences all number
    9
    11
    bursitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    fibromyalgia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    muscle spasms
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    3
    0
    muscular weakness
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 93 (1.08%)
         occurrences all number
    2
    1
    myalgia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    neck pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    osteoarthritis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    0
    2
    osteopenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    pain in extremity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 93 (1.08%)
         occurrences all number
    2
    1
    sjogren's syndrome
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    torticollis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    abscess
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    acarodermatitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 98 (4.08%)
    2 / 93 (2.15%)
         occurrences all number
    6
    2
    cellulitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    chikungunya virus infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 98 (4.08%)
    5 / 93 (5.38%)
         occurrences all number
    4
    5
    colon gangrene
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    conjunctivitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    cystitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    dermatitis infected
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    ear infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    erysipelas
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    fungal infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    fungal skin infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    gastroenteritis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    gastroenteritis viral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 93 (2.15%)
         occurrences all number
    1
    2
    gastrointestinal infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    gingivitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    3
    0
    helicobacter infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    herpes zoster
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    influenza
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 98 (4.08%)
    3 / 93 (3.23%)
         occurrences all number
    4
    3
    laryngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    lung infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    10 / 98 (10.20%)
    16 / 93 (17.20%)
         occurrences all number
    17
    18
    onychomycosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    0
    2
    rhinitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    sinusitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 93 (2.15%)
         occurrences all number
    3
    2
    staphylococcal abscess
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    tonsillitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    tooth infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    7 / 93 (7.53%)
         occurrences all number
    3
    7
    urinary tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    8 / 93 (8.60%)
         occurrences all number
    3
    9
    viral infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 93 (2.15%)
         occurrences all number
    2
    2
    vulvitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    3
    0
    dehydration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    fructose intolerance
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    gout
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    3 / 93 (3.23%)
         occurrences all number
    0
    3
    hypercholesterolaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    hyperglycaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 98 (4.08%)
    0 / 93 (0.00%)
         occurrences all number
    4
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 93 (1.08%)
         occurrences all number
    3
    1
    hyperuricaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    hypoglycaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    8
    hyponatraemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    obesity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    9 / 98 (9.18%)
    3 / 93 (3.23%)
         occurrences all number
    9
    3

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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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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