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    Clinical Trial Results:
    A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study .

    Summary
    EudraCT number
    		 2011-000842-39
    Trial protocol
    		 HU   SK   GB   CZ   DE   LT   ES   GR   FI   IT  
    Global end of trial date
    16 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2018
    First version publication date
    02 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I2R-MC-BIAJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01435616
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 12141
    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
    16 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate that LY2605541 is noninferior to insulin glargine for the change in HbA1c from baseline to 52 weeks of treatment in insulin naive patients with Type 2 Diabetes Mellitus (T2DM).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2011
    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
    United States: 559
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    Mexico: 40
    Country: Number of subjects enrolled
    Puerto Rico: 58
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    Argentina: 101
    Country: Number of subjects enrolled
    Brazil: 30
    Country: Number of subjects enrolled
    Romania: 62
    Country: Number of subjects enrolled
    Australia: 45
    Country: Number of subjects enrolled
    South Africa: 15
    Country: Number of subjects enrolled
    New Zealand: 19
    Country: Number of subjects enrolled
    Poland: 99
    Country: Number of subjects enrolled
    Slovakia: 22
    Country: Number of subjects enrolled
    Spain: 53
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Czech Republic: 13
    Country: Number of subjects enrolled
    Finland: 13
    Country: Number of subjects enrolled
    Germany: 99
    Country: Number of subjects enrolled
    Greece: 30
    Country: Number of subjects enrolled
    Hungary: 102
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Lithuania: 12
    Worldwide total number of subjects
    1538
    EEA total number of subjects
    559
    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)
    1066
    From 65 to 84 years
    469
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered

    Pre-assignment
    Screening details
    		 No text entered

    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
    		 LY2605541
    Arm description
    		 LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2605541
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks.

    Arm title
    		 Glargine
    Arm description
    		 Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks.

    Number of subjects in period 1
    		LY2605541 Glargine
    Started
    1003
    535
    Received at Least 1 Dose of Study Drug
    1003
    535
    Completed
    832
    455
    Not completed
    171
    80
         Adverse event, serious fatal
    7
    2
         Consent withdrawn by subject
    66
    24
         Physician decision
    20
    7
         Adverse event, non-fatal
    39
    21
         Sponsor Decision
    1
    -
         Lost to follow-up
    22
    13
         Protocol deviation
    16
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2605541
    Reporting group description
    		 LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks

    Reporting group title
    Glargine
    Reporting group description
    		 Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks.

    Reporting group values
    		 LY2605541 Glargine Total
    Number of subjects
    		 1003 535 1538
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.80 ± 9.86 59.35 ± 9.80 -
    Gender categorical
    Units: Subjects
        Female
    		 453 227 680
        Male
    		 550 308 858
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 201 96 297
        Not Hispanic or Latino
    		 648 355 1003
        Unknown or Not Reported
    		 154 84 238
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 24 15 39
        Asian
    		 25 12 37
        Native Hawaiian or Other Pacific Islander
    		 3 2 5
        Black or African American
    		 68 34 102
        White
    		 875 469 1344
        More than one race
    		 8 3 11
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    LY2605541
    Reporting group description
    		 LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks

    Reporting group title
    Glargine
    Reporting group description
    		 Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks.

    Primary: Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)

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    End point title
    		 Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
    End point description
    HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol [LDL-C, < 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL] and sulfonylurea [SU]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
    End point type
    Primary
    End point timeframe
    Baseline, 52 weeks Analysis Population Description: All participants who were randomized, had at least 1 dose of study medication, and at least 1 post-baseline HbA1c measurement.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    989
    523
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.55 ± 0.03
    -1.25 ± 0.04
    Statistical analysis title
    		 HbA1c Statistical Analysis
    Comparison groups
    LY2605541 v Glargine
    Number of subjects included in analysis
    1512
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 Mixed Model Repeated Measures (MMRM)
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 -0.19

    Secondary: Rate of Total and Nocturnal Hypoglycemia Events

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    End point title
    		 Rate of Total and Nocturnal Hypoglycemia Events
    End point description
    Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter [mg/dL] or less than 3.9 millimoles per liter [mmol/L]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log [exposure per 30 days] as the offset variable in the model).
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks Analysis Population Description: All participants who were randomized, who received at least 1 dose of study drug, and had evaluable total and/or nocturnal event data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    1001
    535
    Units: episodes/participant/30 days
    least squares mean (standard error)
        Rate of total hypoglycemia events
    1.16 ± 0.06
    1.21 ± 0.07
        Rate of nocturnal hypoglycemia events
    0.30 ± 0.05
    0.40 ± 0.03
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %

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    End point title
    		 Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
    End point description
    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    989
    523
    Units: percentage of participants
    number (not applicable)
        HbA1c ≤ 6.5%
    36.1
    23.9
        HbA1c < 7.0%
    57.6
    42.8
    No statistical analyses for this end point

    Secondary: Fasting Serum Glucose (By Laboratory Measurement)

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    End point title
    		 Fasting Serum Glucose (By Laboratory Measurement)
    End point description
    LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting serum glucose data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    986
    521
    Units: mg/dL
        least squares mean (standard error)
    114.93 ± 1.24
    120.13 ± 1.70
    No statistical analyses for this end point

    Secondary: Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)

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    End point title
    		 Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
    End point description
    LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting blood glucose data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    994
    528
    Units: mg/dL
        least squares mean (standard error)
    112.57 ± 0.82
    112.00 ± 1.12
    No statistical analyses for this end point

    Secondary: 6 Point Self-monitored Blood Glucose (SMBG)

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    End point title
    		 6 Point Self-monitored Blood Glucose (SMBG)
    End point description
    Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable SMBG data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    943
    499
    Units: mg/dL
    least squares mean (standard error)
        Pre-morning meal (n=943, n=499)
    112.81 ± 0.96
    112.26 ± 1.31
        Pre-midday meal (n=925, n=494)
    127.65 ± 1.36
    134.52 ± 1.86
        Pre-evening meal (n=928, n=494)
    133.94 ± 1.40
    142.58 ± 1.91
        Bedtime (n=911, n=486)
    151.37 ± 1.54
    155.19 ± 2.10
        0300 hours (n=909, n=466)
    120.35 ± 1.21
    118.37 ± 1.67
        Pre-morning meal (next day)(n=939, n=494)
    111.11 ± 0.89
    109.19 ± 1.23
    No statistical analyses for this end point

    Secondary: Change From Baseline to 52 Weeks in Body Weight

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    End point title
    		 Change From Baseline to 52 Weeks in Body Weight
    End point description
    LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks Analysis Population Description: All participants who were randomized, who received at least 1 dose of study drug, and had evaluable body weight data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    985
    522
    Units: kilograms (kg)
        least squares mean (standard error)
    2.06 ± 0.15
    2.57 ± 0.21
    No statistical analyses for this end point

    Secondary: Hemoglobin A1c

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    End point title
    		 Hemoglobin A1c
    End point description
    HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    989
    523
    Units: percentage of HbA1c
        least squares mean (standard error)
    6.91 ± 0.03
    7.21 ± 0.04
    No statistical analyses for this end point

    Secondary: Insulin Dose Per Body Weight

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    End point title
    		 Insulin Dose Per Body Weight
    End point description
    LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable insulin dose data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    1001
    532
    Units: units of insulin/kg body weight
        least squares mean (standard error)
    0.45 ± 0.01
    0.42 ± 0.01
    No statistical analyses for this end point

    Secondary: Number of Insulin Dose Adjustments to Steady-State

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    End point title
    		 Number of Insulin Dose Adjustments to Steady-State
    End point description
    Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline insulin data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    1002
    532
    Units: number of insulin dose adjustments
        least squares mean (standard error)
    5.83 ± 0.12
    5.25 ± 0.16
    No statistical analyses for this end point

    Secondary: European Quality of Life-5 Dimension (EQ-5D)

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    End point title
    		 European Quality of Life-5 Dimension (EQ-5D)
    End point description
    The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using a MMRM with baseline stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable EQ-5D data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    892
    474
    Units: units on a scale
        least squares mean (standard error)
    0.88 ± 0.00
    0.88 ± 0.01
    No statistical analyses for this end point

    Secondary: Insulin Treatment Satisfaction Questionnaire

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    End point title
    		 Insulin Treatment Satisfaction Questionnaire
    End point description
    The Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes who are receiving insulin. The questionnaire measures satisfaction from the following 5 domains: inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Data presented are the transformed total score on a scale of 0 to 100, where higher scores indicate better treatment satisfaction. LS means were calculated using a MMRM with stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable ITSQ data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    966
    515
    Units: Insulin Treatment Satisfaction Questionn
        least squares mean (standard error)
    84.73 ± 0.44
    85.04 ± 0.60
    No statistical analyses for this end point

    Secondary: Adult Low Blood Sugar Survey

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    End point title
    		 Adult Low Blood Sugar Survey
    End point description
    The adult Low Blood Sugar Survey (LBSS) is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 4 = always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range of 0 to 132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using an analysis of covariance model (ANCOVA) with baseline LBSS score, stratification factors (country, HbA1c, and SU/meglitinide use), and treatment as fixed effects. Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable LBSS data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    899
    478
    Units: Adult Low Blood Sugar Survey
        least squares mean (standard error)
    15.09 ± 0.49
    14.59 ± 0.67
    No statistical analyses for this end point

    Secondary: Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)

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    End point title
    		 Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
    End point description
    LS means were calculated using a MMRM with baseline lipid measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline lipid measurement.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    992
    528
    Units: milligrams per deciliter (mg/dL)
    least squares mean (standard error)
        Triglycerides (n=992, n=528)
    10.60 ± 2.46
    -7.33 ± 3.38
        LDL-C (n=992, n=527)
    1.44 ± 0.83
    1.76 ± 1.14
        HDL-C (n=992, n=528)
    -1.91 ± 0.21
    -1.82 ± 0.29
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin

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    End point title
    		 Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks Analysis Population Description: All participants who were randomized, had at least 1 dose of study drug, and had at least 1 post-baseline total bilirubin measurement.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    994
    529
    Units: Percentage of Participants With Equal or
    number (not applicable)
        ≥2-fold ULN
    0.2
    0.0
        ≥3-fold ULN
    0.1
    0.0
    No statistical analyses for this end point

    Secondary: Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)

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    End point title
    		 Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
    End point description
    The percentage of participants with a TEAR is summarized. TEAR is defined as a change in the anti-LY2605541 antibody level from undetectable at baseline to detectable at baseline, or, for those participants with detectable antibodies at baseline, change to a value with at least a 130% relative increase from baseline. Overall TEAR is defined as one or more TEAR during the specified period.
    End point type
    Secondary
    End point timeframe
    Baseline to 78 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable TEAR data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    988
    521
    Units: percentage of participants
        number (not applicable)
    43.0
    37.8
    No statistical analyses for this end point

    Secondary: Intra-participant Variability of the Fasting Blood Glucose (FBG)

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    End point title
    		 Intra-participant Variability of the Fasting Blood Glucose (FBG)
    End point description
    Intra-participant variability of FBG, which was measured by SMBG, was assessed by the standard deviation of the FBG measurement at the Week 52 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.
    End point type
    Secondary
    End point timeframe
    52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline FBG data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    991
    522
    Units: mg/dL
        least squares mean (standard error)
    15.56 ± 0.38
    17.08 ± 0.52
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Total and Nocturnal Hypoglycemic Events

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    End point title
    		 Percentage of Participants With Total and Nocturnal Hypoglycemic Events
    End point description
    A hypoglycemic event is defined by a blood glucose value ≤70 mg/dL (3.9mmol/L). Total hypoglycemic events include documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemic events refer to any total hypoglycemic event that occurs between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic or nocturnal hypoglycemic events by the total number of participants analyzed, multiplied by 100.
    End point type
    Secondary
    End point timeframe
    Baseline to 52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable hypoglycemia event data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    1001
    535
    Units: percentage of participants
    number (not applicable)
        Total hypoglycemic events
    77.0
    79.8
        Nocturnal hypoglycemic events
    48.9
    59.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia

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    End point title
    		 Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
    End point description
    The percentage of participants with HbA1C ≤ 6.5% or < 7.0% without nocturnal hypoglycemia is presented. Percentage was calculated by dividing the number of participants with the indicated HbA1c values over the total number of participants and multiplying by 100. Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    989
    523
    Units: percentage of participants
    number (not applicable)
        HbA1c ≤ 6.5%
    17.5
    8.6
        HbA1c < 7.0%
    26.2
    15.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)

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    End point title
    		 Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
    End point description
    The percentage of participants was calculated by dividing the number of participants equal or above 2- or 3-fold ULN for ALT/SGPT or AST/SGOT by the total number of participants analyzed, multiplied by 100.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks Analysis Population Description: All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline liver enzyme data.
    End point values
    		 LY2605541 Glargine
    Number of subjects analysed
    990
    524
    Units: percentage of participants
    number (not applicable)
        ≥2-fold ULN for ALT
    6.5
    4.0
        ≥3-fold ULN for ALT
    1.9
    0.6
        ≥2-fold ULN for AST
    3.6
    1.5
        ≥3-fold ULN for AST
    1.0
    0.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Analysis Period 2 (AP2)
    Adverse event reporting additional description
    I2R-MC-BIAJ
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Glargine
    Reporting group description
    		 -

    Reporting group title
    LY2605541
    Reporting group description
    		 -

    Serious adverse events
    		 Glargine LY2605541
    Total subjects affected by serious adverse events
         subjects affected / exposed
    73 / 535 (13.64%)
    105 / 1003 (10.47%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenocarcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    adenocarcinoma of colon
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign gastric neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bladder transitional cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    breast cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colon cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endometrial adenocarcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    invasive ductal breast carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lentigo maligna
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metastases to salivary gland
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-small cell lung cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophageal cancer metastatic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pancreatic carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer metastatic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer stage iii
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal adenoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma of the tongue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tongue neoplasm malignant stage unspecified
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transitional cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    aortic stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoperfusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    iliac artery occlusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    shock
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Surgical and medical procedures
    coronary artery bypass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    glossectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostatectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radical neck dissection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (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 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    5 / 1003 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    device occlusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    sarcoidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    menorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pelvic floor muscle weakness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pharyngeal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleuritic pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    electrocardiogram qt prolonged
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clavicle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hand fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    scapula fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thoracic vertebral fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (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 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic valve stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    5 / 1003 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial flutter
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block complete
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block second degree
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    cardiac failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac tamponade
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiomyopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    3 / 1003 (0.30%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertensive heart disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    myocardial ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    right ventricular failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    supraventricular tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wolff-parkinson-white syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    autonomic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cervicobrachial syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    complex partial seizures
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhage intracranial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    hemiparesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic cerebral infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lacunar infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vestibular ataxia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    optic ischaemic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vitreous haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric fistula
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroduodenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis eosinophilic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophagitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholangitis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic cirrhosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydrocholecystis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    angioedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    psoriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skin ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urticaria chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vasculitic rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (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
    renal failure acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         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
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal column stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    abdominal abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchopneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    5 / 1003 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholecystitis infective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    escherichia bacteraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gallbladder empyema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    liver abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    localised infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    necrotising fasciitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    osteomyelitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    3 / 1003 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    staphylococcal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    7 / 1003 (0.70%)
         occurrences causally related to treatment / all
    3 / 4
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypokalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypophagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Glargine LY2605541
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    390 / 535 (72.90%)
    733 / 1003 (73.08%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    acrochordon
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    adenoma benign
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    adrenal adenoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    benign breast neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    benign neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    benign neoplasm of thyroid gland
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    melanocytic naevus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    neoplasm prostate
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    neoplasm skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    prostate cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    skin papilloma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    squamous cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    thyroid neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tracheal neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    tumour pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    uterine leiomyoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    angiopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    aortic arteriosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    aortic stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    arteriosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    blood pressure inadequately controlled
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    deep vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    diabetic microangiopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    essential hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    2
    flushing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    hot flush
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 535 (2.24%)
    41 / 1003 (4.09%)
         occurrences all number
    12
    43
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    2 / 1003 (0.20%)
         occurrences all number
    4
    2
    intermittent claudication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    intra-abdominal haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    lymphoedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    orthostatic hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    peripheral vascular disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    thrombophlebitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    varicose vein
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    venous insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    abdominoplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    aortic valve replacement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    apicectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    atherectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blepharoplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    bone lesion excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cardiac pacemaker insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    carpal tunnel decompression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    cataract operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    3 / 1003 (0.30%)
         occurrences all number
    6
    4
    cholecystectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    3 / 1003 (0.30%)
         occurrences all number
    4
    3
    colectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    coronary angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    4
    1
    coronary artery bypass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    cyst removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dental care
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    dental disorder prophylaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dental implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dental operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    endodontic procedure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    explorative laparotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    eye laser surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    finger repair operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gastric operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gastric polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    haemorrhoid operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hip arthroplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hysterectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    knee arthroplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    laryngeal operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    limb operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    lithotripsy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    mammoplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    micrographic skin surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    mitral valve replacement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    mole excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    nail operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    oral surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    percutaneous coronary intervention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    perineoplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    peripheral nerve decompression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pneumonectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    salpingo-oophorectomy bilateral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    sclerotherapy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    skin graft
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    skin neoplasm excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    spermatocele excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    stent placement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    stent removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tendon operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    tendon sheath incision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    toe operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tooth extraction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    11 / 1003 (1.10%)
         occurrences all number
    4
    12
    tooth repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    ureteral stent insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    varicose vein operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    vitrectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    application site pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 535 (1.31%)
    8 / 1003 (0.80%)
         occurrences all number
    8
    9
    axillary pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    chest discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    9 / 1003 (0.90%)
         occurrences all number
    1
    10
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    1
    6
    chronic fatigue syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    4
    drug intolerance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    early satiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    fat tissue increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    14 / 535 (2.62%)
    35 / 1003 (3.49%)
         occurrences all number
    15
    38
    feeling abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    feeling jittery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    feeling of body temperature change
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hunger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hyperpyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    impaired healing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    9 / 1003 (0.90%)
         occurrences all number
    1
    9
    infusion site bruising
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    injection site hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    5
    injection site induration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    injection site inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    injection site oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    injection site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    injection site pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    injection site rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    injection site reaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    injection site swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    irritability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    local swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    4 / 1003 (0.40%)
         occurrences all number
    5
    6
    nodule
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    8 / 1003 (0.80%)
         occurrences all number
    3
    8
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    16 / 535 (2.99%)
    29 / 1003 (2.89%)
         occurrences all number
    18
    34
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    12 / 1003 (1.20%)
         occurrences all number
    3
    14
    puncture site haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    17 / 1003 (1.69%)
         occurrences all number
    5
    18
    spinal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    4
    therapeutic response unexpected
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    thirst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    vessel puncture site bruise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    allergy to arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    allergy to arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    contrast media allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    drug hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    food allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    reaction to food additive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 535 (1.31%)
    7 / 1003 (0.70%)
         occurrences all number
    7
    9
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    4 / 1003 (0.40%)
         occurrences all number
    3
    4
    breast mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    dysmenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    6
    endometrial hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    epididymal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    epididymitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    erectile dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    6 / 1003 (0.60%)
         occurrences all number
    0
    6
    menstruation irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    metrorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    orchitis noninfective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    pelvic pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    penis disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    postmenopausal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    premenstrual syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    prostatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    2 / 1003 (0.20%)
         occurrences all number
    5
    2
    prostatomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    scrotal mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    testicular pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    5
    vaginal discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    vulvovaginal pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    allergic sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    apnoeic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    7 / 1003 (0.70%)
         occurrences all number
    3
    11
    atelectasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    1
    4
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 535 (3.36%)
    44 / 1003 (4.39%)
         occurrences all number
    22
    52
    dysphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    15 / 1003 (1.50%)
         occurrences all number
    2
    16
    dyspnoea exertional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    emphysema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    4
    3
    lung disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    8 / 1003 (0.80%)
         occurrences all number
    4
    8
    nasal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nasal septum deviation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nasal septum perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    19 / 535 (3.55%)
    34 / 1003 (3.39%)
         occurrences all number
    21
    40
    orthopnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    paranasal sinus hypersecretion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    pleural effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    pleurisy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pneumonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    productive cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    7 / 1003 (0.70%)
         occurrences all number
    0
    8
    pulmonary congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pulmonary fibrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pulmonary hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    respiratory disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    2 / 1003 (0.20%)
         occurrences all number
    6
    2
    respiratory distress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    7 / 1003 (0.70%)
         occurrences all number
    1
    7
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    6 / 1003 (0.60%)
         occurrences all number
    3
    6
    rhinitis seasonal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    sinus congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    6 / 1003 (0.60%)
         occurrences all number
    5
    6
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    3 / 1003 (0.30%)
         occurrences all number
    6
    3
    sneezing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    throat irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    tonsillar inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    upper respiratory tract inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    upper-airway cough syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    wheezing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    4
    Psychiatric disorders
    abnormal behaviour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    adjustment disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    affect lability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    agitation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 535 (1.31%)
    11 / 1003 (1.10%)
         occurrences all number
    8
    11
    confusional state
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    daydreaming
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    depressed mood
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    10 / 1003 (1.00%)
         occurrences all number
    6
    10
    disorientation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    drug abuse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    fear of eating
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 535 (2.06%)
    15 / 1003 (1.50%)
         occurrences all number
    11
    16
    libido decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    mental disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    mental disorder due to a general medical condition
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nervousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    nightmare
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    obsessive-compulsive disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    panic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    personality disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    phonophobia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    restlessness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    sleep disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    stress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    4
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    24 / 1003 (2.39%)
         occurrences all number
    3
    25
    amino acid level increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    angiogram
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    antinuclear antibody positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    arteriogram coronary
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    15 / 1003 (1.50%)
         occurrences all number
    2
    15
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blood bicarbonate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blood bilirubin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blood calcium increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blood creatine increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 535 (2.24%)
    9 / 1003 (0.90%)
         occurrences all number
    12
    9
    blood creatinine increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    blood glucose increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blood iron decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blood magnesium decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blood potassium decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blood potassium increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blood pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    3
    3
    blood testosterone decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    1 / 1003 (0.10%)
         occurrences all number
    4
    1
    blood triglycerides increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    8 / 1003 (0.80%)
         occurrences all number
    0
    8
    blood urea increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    blood uric acid increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    blood urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    bronchoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    catheterisation cardiac
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    colonoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    electrocardiogram p wave abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    electrocardiogram st-t segment abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    electrocardiogram t wave inversion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    electrocardiogram abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    electroencephalogram abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    eosinophil count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gastric ph decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    haematocrit increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    haemoglobin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    heart rate irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    helicobacter test positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hepatic enzyme abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    hepatitis b antibody positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    human chorionic gonadotropin abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    human chorionic gonadotropin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    left ventricular end-diastolic pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    liver function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    lymphocyte morphology abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    mean cell haemoglobin decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    mean cell volume decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    oesophagogastroduodenoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    platelet count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    prostatic specific antigen increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    3
    protein urine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    protein urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    qrs axis abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    serum ferritin decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    vitamin d decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    vitamin d increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    waist circumference increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    weight decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 535 (3.36%)
    26 / 1003 (2.59%)
         occurrences all number
    18
    28
    white blood cell count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    white blood cells urine positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    anaemia postoperative
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    animal bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    ankle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    11 / 1003 (1.10%)
         occurrences all number
    7
    11
    arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    asbestosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    avulsion fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    back injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    bone contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 1003 (0.00%)
         occurrences all number
    3
    0
    burns first degree
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    chest crushing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    chest injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    17 / 1003 (1.69%)
         occurrences all number
    9
    20
    epicondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    excoriation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    1
    8
    exposure to toxic agent
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    facial bones fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    9 / 1003 (0.90%)
         occurrences all number
    3
    12
    fibula fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    5 / 1003 (0.50%)
         occurrences all number
    2
    6
    foreign body
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    foreign body in eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    hand fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    3
    head injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    heat exhaustion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    joint dislocation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    3 / 1003 (0.30%)
         occurrences all number
    4
    4
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 535 (1.31%)
    2 / 1003 (0.20%)
         occurrences all number
    7
    2
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    9 / 1003 (0.90%)
         occurrences all number
    3
    9
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 535 (1.68%)
    6 / 1003 (0.60%)
         occurrences all number
    9
    6
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    2
    5
    liver contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    muscle contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    muscle rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    10 / 1003 (1.00%)
         occurrences all number
    2
    10
    nail avulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    nail injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    patella fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pelvic fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    periorbital haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    post procedural complication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    post-traumatic neck syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    postoperative respiratory failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    procedural pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    radius fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    scratch
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    skeletal injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    soft tissue injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    spinal compression fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    spinal fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    stab wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tendon injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    thermal burn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    traumatic fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    upper limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    vaccination complication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    3 / 1003 (0.30%)
         occurrences all number
    3
    3
    Congenital, familial and genetic disorders
    atrial septal defect
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    corneal dystrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    kidney duplex
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    phimosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    type v hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    aortic valve incompetence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    arrhythmia supraventricular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    3 / 1003 (0.30%)
         occurrences all number
    3
    4
    atrioventricular block first degree
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    bundle branch block left
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    bundle branch block right
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 1003 (0.00%)
         occurrences all number
    3
    0
    cardiac aneurysm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    cardiac arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cardiac failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    3
    cardiac failure congestive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    0 / 1003 (0.00%)
         occurrences all number
    5
    0
    cardiomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cardiomyopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    conduction disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    coronary artery disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    3 / 1003 (0.30%)
         occurrences all number
    4
    3
    coronary ostial stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    diastolic dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    ischaemic cardiomyopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    left ventricular failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    left ventricular hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    mitral valve incompetence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    myocardial ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    palpitations
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    7 / 1003 (0.70%)
         occurrences all number
    7
    8
    pericardial effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    prinzmetal angina
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pulmonary valve incompetence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    silent myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    sinus bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    supraventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    tachyarrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    tricuspid valve incompetence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    ventricular arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    ventricular hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    ventricular tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    altered state of consciousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    amnesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    autonomic nervous system imbalance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    2
    balance disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    1
    4
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    7 / 1003 (0.70%)
         occurrences all number
    3
    7
    cerebrovascular accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    cervical root pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cervicobrachial syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    convulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    diabetic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    9 / 1003 (0.90%)
         occurrences all number
    6
    9
    disturbance in attention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    17 / 535 (3.18%)
    32 / 1003 (3.19%)
         occurrences all number
    29
    36
    dizziness postural
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 1003 (0.00%)
         occurrences all number
    3
    0
    dysgeusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    37 / 535 (6.92%)
    85 / 1003 (8.47%)
         occurrences all number
    72
    134
    hemiparesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    14 / 1003 (1.40%)
         occurrences all number
    2
    15
    lacunar infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    lethargy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    memory impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    meralgia paraesthetica
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    9 / 1003 (0.90%)
         occurrences all number
    4
    15
    nerve compression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    neuralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    4 / 1003 (0.40%)
         occurrences all number
    6
    6
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 535 (1.50%)
    12 / 1003 (1.20%)
         occurrences all number
    10
    13
    parkinsonism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    partial seizures
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    post-traumatic headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    presyncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    radiculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    radiculopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    restless legs syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    sciatica
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 535 (1.68%)
    6 / 1003 (0.60%)
         occurrences all number
    9
    7
    sinus headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    somnolence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    spinal cord disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    5 / 1003 (0.50%)
         occurrences all number
    0
    5
    transient ischaemic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tremor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences all number
    3
    5
    viith nerve paralysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    1
    5
    white matter lesion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    14 / 1003 (1.40%)
         occurrences all number
    5
    17
    anaemia macrocytic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    coagulopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    eosinophilia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hypersplenism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    iron deficiency anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    leukocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    lymphadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    lymphadenopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    lymphocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pernicious anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    splenomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    cerumen impaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    deafness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    deafness bilateral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    ear discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    ear pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 535 (1.50%)
    7 / 1003 (0.70%)
         occurrences all number
    10
    8
    eustachian tube disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hypoacusis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    otosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tympanic membrane perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    12 / 1003 (1.20%)
         occurrences all number
    8
    13
    vertigo positional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    vestibular disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    Eye disorders
    arcus lipoides
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    asthenopia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blepharitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blepharospasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    blindness unilateral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cataract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    10 / 1003 (1.00%)
         occurrences all number
    1
    11
    chalazion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences all number
    3
    5
    conjunctivitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    dacryostenosis acquired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    diabetic retinopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    6 / 1003 (0.60%)
         occurrences all number
    1
    6
    diplopia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    dry eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    eye allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    eye discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    eye haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    eye pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    eye pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    eye swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    glaucoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    iris neovascularisation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    iritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    keratitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    macular oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    maculopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    ocular hyperaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    ocular hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    open angle glaucoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    optic ischaemic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    photophobia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    retinal exudates
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    retinopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    sudden visual loss
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    3
    vision blurred
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    8 / 1003 (0.80%)
         occurrences all number
    1
    9
    visual acuity reduced
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    visual impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    vitreous floaters
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    vitreous haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    9 / 1003 (0.90%)
         occurrences all number
    0
    9
    abdominal distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    8 / 1003 (0.80%)
         occurrences all number
    2
    8
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 535 (1.87%)
    13 / 1003 (1.30%)
         occurrences all number
    12
    14
    abdominal pain lower
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    19 / 1003 (1.89%)
         occurrences all number
    6
    24
    abnormal faeces
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    anal fistula
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    aphthous stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    ascites
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    barrett's oesophagus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    change of bowel habit
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    chapped lips
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    colitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    3
    colitis psychogenic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 535 (1.31%)
    6 / 1003 (0.60%)
         occurrences all number
    7
    6
    dental caries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    38 / 535 (7.10%)
    57 / 1003 (5.68%)
         occurrences all number
    52
    81
    diverticulum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    dry mouth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    1
    4
    duodenal ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    duodenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    13 / 1003 (1.30%)
         occurrences all number
    7
    15
    dysphagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    epigastric discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    eructation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    faecaloma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    flatulence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    6 / 1003 (0.60%)
         occurrences all number
    3
    6
    food poisoning
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    6 / 1003 (0.60%)
         occurrences all number
    5
    6
    gastric mucosa erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gastric polyps
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gastric ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    9 / 1003 (0.90%)
         occurrences all number
    3
    9
    gastritis atrophic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gastritis erosive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gastrointestinal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    8 / 1003 (0.80%)
         occurrences all number
    4
    8
    gingival disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gingival inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gingival pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    haematochezia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    haemorrhoids
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    hiatus hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    hyperchlorhydria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    13
    inguinal hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    irritable bowel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    large intestine polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    lip swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    mouth ulceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 535 (3.36%)
    37 / 1003 (3.69%)
         occurrences all number
    30
    51
    oesophageal ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    oesophagitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    oral disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    oral pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pancreatitis chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    paraesthesia oral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    periodontal disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    rectal polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tongue disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    toothache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    22 / 1003 (2.19%)
         occurrences all number
    3
    27
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    16 / 535 (2.99%)
    35 / 1003 (3.49%)
         occurrences all number
    21
    49
    Hepatobiliary disorders
    biliary colic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    biliary dyskinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cholecystitis chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    4 / 1003 (0.40%)
         occurrences all number
    3
    4
    hepatic steatosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    7 / 1003 (0.70%)
         occurrences all number
    1
    7
    hepatomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hypertransaminasaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    non-alcoholic steatohepatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    post cholecystectomy syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    actinic keratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    alopecia areata
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    blister
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    blood blister
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    cold sweat
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 1003 (0.00%)
         occurrences all number
    4
    0
    cutaneous sarcoidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dandruff
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    decubitus ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dermal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    7 / 1003 (0.70%)
         occurrences all number
    3
    9
    dermatitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    3 / 1003 (0.30%)
         occurrences all number
    3
    3
    dermatitis atopic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    dermatitis contact
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    diabetic foot
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    drug eruption
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dry skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    6 / 1003 (0.60%)
         occurrences all number
    0
    6
    eczema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    4 / 1003 (0.40%)
         occurrences all number
    4
    4
    eczema nummular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    1
    7
    hand dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    hidradenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    hyperhidrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    2 / 1003 (0.20%)
         occurrences all number
    4
    2
    hyperkeratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    ingrowing nail
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    2
    ingrown hair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    lentigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    lichen sclerosus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    lipodystrophy acquired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    lipohypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    21 / 1003 (2.09%)
         occurrences all number
    2
    22
    macule
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nail disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    neurodermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    night sweats
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    panniculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    papule
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pemphigus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pigmentation disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    precancerous skin lesion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    7 / 1003 (0.70%)
         occurrences all number
    4
    7
    pruritus allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pruritus generalised
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    psoriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    5
    3
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 535 (1.31%)
    24 / 1003 (2.39%)
         occurrences all number
    8
    27
    rash erythematous
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    rash generalised
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    rash macular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    rash pruritic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    rosacea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    sebaceous hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    seborrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    skin burning sensation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    skin discolouration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    skin exfoliation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    skin fissures
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    skin hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    skin induration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    skin irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    skin lesion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    skin mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    skin odour abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    skin ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    4 / 1003 (0.40%)
         occurrences all number
    3
    5
    telangiectasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    3 / 1003 (0.30%)
         occurrences all number
    3
    4
    Renal and urinary disorders
    bladder diverticulum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    bladder irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    bladder prolapse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    diabetic nephropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    1
    5
    haematuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    hypertonic bladder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    micturition disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    micturition urgency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nephritic syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    nephrolithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 535 (1.50%)
    8 / 1003 (0.80%)
         occurrences all number
    9
    10
    nephropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nocturia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    pollakiuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    proteinuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    renal colic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    renal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    4
    1
    renal failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    renal failure chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    renal impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    renal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    urinary hesitation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    urinary incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    urinary tract disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    urinary tract obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    urinary tract pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    urine flow decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    urine odour abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    Endocrine disorders
    goitre
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hyperthyroidism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hypothyroidism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences all number
    3
    5
    toxic nodular goitre
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    20 / 535 (3.74%)
    52 / 1003 (5.18%)
         occurrences all number
    47
    68
    arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    8 / 1003 (0.80%)
         occurrences all number
    4
    9
    arthropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    36 / 535 (6.73%)
    70 / 1003 (6.98%)
         occurrences all number
    47
    89
    bone loss
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    bone pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    5 / 1003 (0.50%)
         occurrences all number
    2
    5
    chondrocalcinosis pyrophosphate
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    chondropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    costochondritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    facet joint syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    fibromyalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    flank pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 1003 (0.00%)
         occurrences all number
    3
    0
    gouty arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    intervertebral disc disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    joint stiffness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    joint swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    ligament pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    metatarsalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    muscle contracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 535 (1.68%)
    21 / 1003 (2.09%)
         occurrences all number
    9
    21
    muscle swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    muscular weakness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    1
    5
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    16 / 535 (2.99%)
    22 / 1003 (2.19%)
         occurrences all number
    16
    24
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    2 / 1003 (0.20%)
         occurrences all number
    4
    2
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    18 / 1003 (1.79%)
         occurrences all number
    6
    26
    myosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    myositis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    neck pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    6 / 1003 (0.60%)
         occurrences all number
    4
    7
    neuropathic arthropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    3
    0
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 535 (1.87%)
    14 / 1003 (1.40%)
         occurrences all number
    11
    15
    osteochondrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    25 / 535 (4.67%)
    42 / 1003 (4.19%)
         occurrences all number
    36
    50
    pain in jaw
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    periarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    2 / 1003 (0.20%)
         occurrences all number
    2
    2
    plantar fasciitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    polyarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    rheumatoid arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    3
    rotator cuff syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    1
    6
    scoliosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    spinal column stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    spinal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    spinal osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences all number
    3
    5
    spondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    synovial cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    temporomandibular joint syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tendonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    5 / 1003 (0.50%)
         occurrences all number
    2
    5
    trigger finger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    Infections and infestations
    abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    abscess jaw
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    abscess limb
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    4
    abscess neck
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    acne pustular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    acute sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    acute tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    2
    4
    anal abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    body tinea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    breast cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    bronchiolitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    24 / 535 (4.49%)
    52 / 1003 (5.18%)
         occurrences all number
    26
    60
    bronchitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    bronchitis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    bronchopneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    campylobacter infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    carbuncle
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    9 / 1003 (0.90%)
         occurrences all number
    6
    9
    chronic hepatitis b
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    chronic sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    conjunctivitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    conjunctivitis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    cystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 535 (0.75%)
    6 / 1003 (0.60%)
         occurrences all number
    4
    12
    diverticulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    6 / 1003 (0.60%)
         occurrences all number
    1
    6
    ear infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    9 / 1003 (0.90%)
         occurrences all number
    4
    10
    enterovirus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    erysipelas
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    eye infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    eye infection bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    folliculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    5 / 1003 (0.50%)
         occurrences all number
    2
    5
    fungal skin infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    furuncle
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    4 / 1003 (0.40%)
         occurrences all number
    0
    4
    gangrene
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gardnerella infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 535 (1.50%)
    13 / 1003 (1.30%)
         occurrences all number
    8
    14
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 535 (1.50%)
    15 / 1003 (1.50%)
         occurrences all number
    8
    20
    gastrointestinal viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    genital infection fungal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gingival infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    gingivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    helicobacter infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    2
    3
    hepatitis c
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    hepatitis e
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    herpes simplex
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    herpes virus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    7 / 1003 (0.70%)
         occurrences all number
    6
    8
    hordeolum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    incision site infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    infected dermal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    2
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    28 / 535 (5.23%)
    59 / 1003 (5.88%)
         occurrences all number
    35
    68
    injection site cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    kidney infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    labyrinthitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    laryngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    5 / 1003 (0.50%)
         occurrences all number
    0
    5
    lobar pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    localised infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    4 / 1003 (0.40%)
         occurrences all number
    5
    4
    lower respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    11 / 1003 (1.10%)
         occurrences all number
    5
    14
    measles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    nail infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    82 / 535 (15.33%)
    141 / 1003 (14.06%)
         occurrences all number
    122
    196
    nematodiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    onychomycosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    6 / 1003 (0.60%)
         occurrences all number
    2
    6
    oral candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    oral herpes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    2 / 1003 (0.20%)
         occurrences all number
    4
    3
    otitis externa
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    1
    4
    otitis media
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences all number
    3
    5
    otitis media acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    paronychia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    parotitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    penile infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    periodontitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    14 / 1003 (1.40%)
         occurrences all number
    7
    18
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    2
    pharyngotonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    pilonidal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    10 / 1003 (1.00%)
         occurrences all number
    2
    11
    post procedural infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    prostate infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pulpitis dental
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pyelonephritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    pyelonephritis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    6 / 1003 (0.60%)
         occurrences all number
    3
    6
    respiratory tract infection viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 535 (1.50%)
    5 / 1003 (0.50%)
         occurrences all number
    10
    6
    rhinovirus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    4
    sialoadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    16 / 535 (2.99%)
    38 / 1003 (3.79%)
         occurrences all number
    17
    51
    sinusitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    skin candida
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    small intestinal bacterial overgrowth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    subcutaneous abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    tinea cruris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tinea infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    tinea pedis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    5 / 1003 (0.50%)
         occurrences all number
    0
    6
    tinea versicolour
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    3 / 1003 (0.30%)
         occurrences all number
    3
    3
    tooth abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    12 / 1003 (1.20%)
         occurrences all number
    2
    13
    tooth infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    9 / 1003 (0.90%)
         occurrences all number
    3
    10
    tracheitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    tracheobronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    tuberculosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    33 / 535 (6.17%)
    83 / 1003 (8.28%)
         occurrences all number
    48
    119
    urethritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    22 / 535 (4.11%)
    47 / 1003 (4.69%)
         occurrences all number
    28
    57
    viraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 535 (1.12%)
    12 / 1003 (1.20%)
         occurrences all number
    7
    12
    viral rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    viral tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    4 / 1003 (0.40%)
         occurrences all number
    1
    4
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    vulvovaginitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    yersinia infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    1 / 1003 (0.10%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    abnormal loss of weight
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    1 / 1003 (0.10%)
         occurrences all number
    2
    1
    abnormal weight gain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    4 / 1003 (0.40%)
         occurrences all number
    3
    4
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    5 / 1003 (0.50%)
         occurrences all number
    3
    5
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    dyslipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 535 (0.93%)
    5 / 1003 (0.50%)
         occurrences all number
    6
    5
    fluid retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    2 / 1003 (0.20%)
         occurrences all number
    1
    2
    food craving
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    gout
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    8 / 1003 (0.80%)
         occurrences all number
    1
    9
    hypercholesterolaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    1 / 1003 (0.10%)
         occurrences all number
    3
    1
    hyperglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    hyperkalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    0 / 1003 (0.00%)
         occurrences all number
    4
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    6 / 1003 (0.60%)
         occurrences all number
    0
    6
    hyperuricaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    3 / 1003 (0.30%)
         occurrences all number
    1
    3
    hypoalbuminaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    hypokalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    3 / 1003 (0.30%)
         occurrences all number
    0
    3
    increased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    6 / 1003 (0.60%)
         occurrences all number
    0
    6
    iron deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 535 (0.37%)
    0 / 1003 (0.00%)
         occurrences all number
    2
    0
    obesity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    1 / 1003 (0.10%)
         occurrences all number
    1
    1
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 535 (0.19%)
    0 / 1003 (0.00%)
         occurrences all number
    1
    0
    vitamin b12 deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 535 (0.00%)
    2 / 1003 (0.20%)
         occurrences all number
    0
    2
    vitamin d deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 535 (0.56%)
    6 / 1003 (0.60%)
         occurrences all number
    3
    6

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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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