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    Clinical Trial Results:
    The Impact of LY2605541 versus Insulin Glargine for Patients with Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin with Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 Study

    Summary
    EudraCT number
    2011-001254-29
    Trial protocol
    DE   HU   SK   GB   CZ   AT   ES   LT   GR   IT   DK   NL   SI  
    Global end of trial date
    13 Aug 2013

    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-BIAM
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01468987
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 12145
    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
    13 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is: - To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. - To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. - To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. - To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.
    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
    01 Dec 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: 546
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    Slovakia: 42
    Country: Number of subjects enrolled
    Greece: 23
    Country: Number of subjects enrolled
    Spain: 65
    Country: Number of subjects enrolled
    Lithuania: 6
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    Austria: 15
    Country: Number of subjects enrolled
    Russian Federation: 39
    Country: Number of subjects enrolled
    Israel: 40
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Italy: 32
    Country: Number of subjects enrolled
    Czech Republic: 45
    Country: Number of subjects enrolled
    Hungary: 72
    Country: Number of subjects enrolled
    Mexico: 25
    Country: Number of subjects enrolled
    Puerto Rico: 46
    Country: Number of subjects enrolled
    Poland: 40
    Country: Number of subjects enrolled
    Brazil: 24
    Country: Number of subjects enrolled
    Romania: 65
    Country: Number of subjects enrolled
    Croatia: 7
    Country: Number of subjects enrolled
    Denmark: 12
    Country: Number of subjects enrolled
    Australia: 51
    Country: Number of subjects enrolled
    Netherlands: 15
    Country: Number of subjects enrolled
    Germany: 104
    Country: Number of subjects enrolled
    Japan: 21
    Worldwide total number of subjects
    1369
    EEA total number of subjects
    551
    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)
    1065
    From 65 to 84 years
    304
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study contains a screening period, followed by randomization and an intensive insulin optimization period (0-12 weeks) when insulin is adjusted weekly, and a maintenance adjustment period (12-26 weeks).

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    LY2605541 + Insulin Lispro
    Arm description
    Participants were randomized to receive LY2605541 plus Insulin Lispro. Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    LY2605541
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

    Arm title
    Insulin Glargine + Insulin Lispro
    Arm description
    Participants were randomized to receive Insulin Glargine plus Insulin Lispro. Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.
    Arm type
    Active comparator

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Humalog
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

    Number of subjects in period 1
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Started
    691
    678
    Received at least 1 dose of study drug
    691
    677
    Completed
    620
    618
    Not completed
    71
    60
         Adverse event, serious fatal
    4
    1
         Consent withdrawn by subject
    28
    28
         Physician decision
    8
    15
         Adverse event, non-fatal
    12
    9
         Sponsor Decision
    1
    -
         Lost to follow-up
    10
    5
         Protocol deviation
    8
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2605541 + Insulin Lispro
    Reporting group description
    Participants were randomized to receive LY2605541 plus Insulin Lispro. Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

    Reporting group title
    Insulin Glargine + Insulin Lispro
    Reporting group description
    Participants were randomized to receive Insulin Glargine plus Insulin Lispro. Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

    Reporting group values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro Total
    Number of subjects
    691 678 1369
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    57.43 ± 9.21 57.77 ± 9.17 -
    Gender, Male/Female
    Units: Participants
        Female
    315 274 589
        Male
    376 404 780
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    74 78 152
        Not Hispanic or Latino
    452 427 879
        Unknown or Not Reported
    165 173 338
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    2 2 4
        Asian
    25 30 55
        Native Hawaiian or Other Pacific Islander
    2 2 4
        Black or African American
    42 50 92
        White
    615 585 1200
        More than one race
    5 9 14
        Unknown or Not Reported
    0 0 0
    Region of Enrollment
    Units: Subjects
        United States
    276 270 546
        Taiwan
    7 8 15
        Slovakia
    25 17 42
        Greece
    12 11 23
        Spain
    30 35 65
        Lithuania
    4 2 6
        Turkey
    4 7 11
        Austria
    9 6 15
        Russian Federation
    19 20 39
        Israel
    20 20 40
        United Kingdom
    5 3 8
        Italy
    16 16 32
        Czech Republic
    23 22 45
        Hungary
    36 36 72
        Mexico
    13 12 25
        Puerto Rico
    20 26 46
        Poland
    20 20 40
        Brazil
    11 13 24
        Romania
    34 31 65
        Croatia
    5 2 7
        Denmark
    9 3 12
        Australia
    26 25 51
        Netherlands
    7 8 15
        Germany
    50 54 104
        Japan
    10 11 21

    End points

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    End points reporting groups
    Reporting group title
    LY2605541 + Insulin Lispro
    Reporting group description
    Participants were randomized to receive LY2605541 plus Insulin Lispro. Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

    Reporting group title
    Insulin Glargine + Insulin Lispro
    Reporting group description
    Participants were randomized to receive Insulin Glargine plus Insulin Lispro. Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

    Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks

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    End point title
    Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
    End point description
    HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.
    End point type
    Primary
    End point timeframe
    Baseline, 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    684
    672
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.66 ± 0.04
    -1.45 ± 0.04
    Statistical analysis title
    Statistical analysis
    Statistical analysis description
    95% Confidence interval (CI) and Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol [LDL-C, less than (<) 100 milligrams per deciliter (mg/dL) and greater than or equal to (≥) 100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
    Comparison groups
    LY2605541 + Insulin Lispro v Insulin Glargine + Insulin Lispro
    Number of subjects included in analysis
    1356
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Mixed models analysis
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.31
         upper limit
    -0.11
    Notes
    [1] - Non-inferiority margin was 0.4%.

    Secondary: Total hypoglycemia rates (Adjusted for 30 days)

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    End point title
    Total hypoglycemia rates (Adjusted for 30 days)
    End point description
    Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of less than or equal to (≤) mg/dL (3.9 millimoles per liter [mmol/L]). Arithmetic mean rates of total hypoglycemia (per 30 days) are presented and were calculated from the mean of hypo rate of participants within each treatment. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    689
    676
    Units: episodes/participant/30 days
        arithmetic mean (standard deviation)
    5.52 ± 5.27
    5.46 ± 5.46
    No statistical analyses for this end point

    Secondary: Percentage of participants with total hypoglycemia episodes

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    End point title
    Percentage of participants with total hypoglycemia episodes
    End point description
    Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    689
    676
    Units: percentage of participants
        number (not applicable)
    95.2
    96.6
    No statistical analyses for this end point

    Secondary: Nocturnal hypoglycemia rates (Adjusted for 30 days)

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    End point title
    Nocturnal hypoglycemia rates (Adjusted for 30 days)
    End point description
    Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Arithmetic mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from the mean of hypo rate of participants within each treatment. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    689
    676
    Units: events/participant/30 days
        arithmetic mean (standard deviation)
    0.49 ± 0.85
    0.9 ± 1.35
    No statistical analyses for this end point

    Secondary: Percentage of participants with nocturnal hypoglycemia episodes

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    End point title
    Percentage of participants with nocturnal hypoglycemia episodes
    End point description
    Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    689
    676
    Units: percentage of participants
        number (not applicable)
    59.5
    74
    No statistical analyses for this end point

    Secondary: Body Weight Change From Baseline to 26 Weeks

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    End point title
    Body Weight Change From Baseline to 26 Weeks
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    682
    671
    Units: kilograms (kg)
        least squares mean (standard error)
    1.25 ± 0.16
    2.21 ± 0.16
    No statistical analyses for this end point

    Secondary: Self-Monitored Blood Glucose (SMBG) 9-point profiles at 26 weeks

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    End point title
    Self-Monitored Blood Glucose (SMBG) 9-point profiles at 26 weeks
    End point description
    9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline BG values. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    639
    619
    Units: mg/dL
    least squares mean (standard error)
        Pre-morning meal (n=639, 619)
    137.31 ± 1.63
    133.81 ± 1.66
        2 hours post-morning meal (n=545, 538)
    162.77 ± 2.59
    156.41 ± 2.64
        Pre-midday meal (n=606, 584)
    130.02 ± 1.97
    133.63 ± 2.02
        2 hours post-midday meal (n=548, 550)
    145.55 ± 2.67
    156.17 ± 2.72
        Pre-evening meal (n=611, 595)
    142.65 ± 2.09
    149.19 ± 2.14
        2 hours post-evening meal (n=552, 536)
    156.56 ± 2.72
    166.59 ± 2.85
        Bedtime (n=587, 557)
    160.15 ± 2.6
    163.62 ± 2.7
        0300 hours (n=516, 487)
    143.9 ± 2.54
    140.19 ± 2.59
        Pre-morning meal next day (n=605, 588)
    135.09 ± 1.77
    132.07 ± 1.81
    No statistical analyses for this end point

    Secondary: Percentage of participants with HbA1c <7.0% and ≤6.5% at 26 weeks

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    End point title
    Percentage of participants with HbA1c <7.0% and ≤6.5% at 26 weeks
    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. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c 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 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    684
    672
    Units: percentage of participants
    number (not applicable)
        HbA1c ≤6.5%
    44.4
    32.6
        HbA1c <7.0%
    63.3
    53.3
    No statistical analyses for this end point

    Secondary: Percentage of participants with HbA1c <7.0% without nocturnal hypoglycemia at 26 weeks

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    End point title
    Percentage of participants with HbA1c <7.0% without nocturnal hypoglycemia at 26 weeks
    End point description
    Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.
    End point type
    Secondary
    End point timeframe
    up to 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    684
    672
    Units: percentage of participants
        number (not applicable)
    23.7
    12.2
    No statistical analyses for this end point

    Secondary: Basal, bolus, and total insulin dose by weight at 26 weeks

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    End point title
    Basal, bolus, and total insulin dose by weight at 26 weeks
    End point description
    Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and baseline number of insulin injections [1, 2, or ≥3]). Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    615
    613
    Units: units/kg/day
    least squares mean (standard error)
        Basal Insulin (n=612, 606)
    0.68 ± 0.01
    0.6 ± 0.01
        Bolus Insulin (n=591, 591)
    0.61 ± 0.02
    0.63 ± 0.02
        Total Insulin (n=615, 613)
    1.27 ± 0.02
    1.21 ± 0.02
    No statistical analyses for this end point

    Secondary: Fasting serum glucose (FSG) from laboratory at 26 weeks

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    End point title
    Fasting serum glucose (FSG) from laboratory at 26 weeks
    End point description
    LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FSG. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    683
    672
    Units: mg/dL
        least squares mean (standard error)
    125.33 ± 1.93
    132.02 ± 1.94
    No statistical analyses for this end point

    Secondary: Fasting blood glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks

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    End point title
    Fasting blood glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
    End point description
    FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FBG variability. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    674
    652
    Units: mg/dL
        least squares mean (standard error)
    28.67 ± 0.79
    33.54 ± 0.8
    No statistical analyses for this end point

    Secondary: 0300-hour blood glucose to FBG excursion at 26 weeks

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    End point title
    0300-hour blood glucose to FBG excursion at 26 weeks
    End point description
    Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline excursion. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    470
    450
    Units: mg/dL
        least squares mean (standard error)
    -11.95 ± 2.34
    -15.16 ± 2.37
    No statistical analyses for this end point

    Secondary: HbA1c at 26 weeks

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    End point title
    HbA1c at 26 weeks
    End point description
    HbA1c is a test that measures a participant’s average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for stratification factors (country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment, visit-by-treatment interaction, and baseline HbA1c. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    684
    672
    Units: percentage of HbA1c
        least squares mean (standard error)
    6.76 ± 0.04
    6.97 ± 0.04
    No statistical analyses for this end point

    Secondary: Lipid profile at 26 weeks

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    End point title
    Lipid profile at 26 weeks
    End point description
    Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable], number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    684
    674
    Units: mg/dL
    least squares mean (standard error)
        Cholesterol (n=613, 609)
    177.17 ± 1.13
    174.79 ± 1.14
        HDL-C (n=611, 603)
    46.44 ± 0.27
    47.71 ± 0.27
        LDL-C (n=609, 603)
    97.87 ± 0.99
    98.89 ± 0.99
        Triglycerides (n=614, 609)
    168.79 ± 2.85
    141.78 ± 2.86
    No statistical analyses for this end point

    Secondary: Number of participants with change in anti-LY2605541 antibodies from baseline to 26 weeks

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    End point title
    Number of participants with change in anti-LY2605541 antibodies from baseline to 26 weeks
    End point description
    The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    682
    672
    Units: participants
        number (not applicable)
    152
    161
    No statistical analyses for this end point

    Secondary: Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 weeks

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    End point title
    Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 weeks
    End point description
    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥3]) as fixed effects and baseline value of the ITSQ scores as a covariate. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    up to 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    631
    637
    Units: units on a scale
        least squares mean (standard error)
    77.01 ± 0.55
    77.29 ± 0.54
    No statistical analyses for this end point

    Secondary: Low Blood Sugar Survey (LBSS) at 26 weeks

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    End point title
    Low Blood Sugar Survey (LBSS) at 26 weeks
    End point description
    LBSS (also referenced as Hypoglycemia Fear Survey – II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM including stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline number of insulin injections [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline LBSS score. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    682
    671
    Units: units on a scale
        least squares mean (standard error)
    21.44 ± 0.56
    21.67 ± 0.56
    No statistical analyses for this end point

    Secondary: EuroQoL-5D (EQ-5D) at 26 weeks

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    End point title
    EuroQoL-5D (EQ-5D) at 26 weeks
    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 three level scale of 1-3 (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 ANCOVA adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥ 3]), and baseline EQ-5D score. Analysis population included participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    up to 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    636
    644
    Units: units on a scale
        least squares mean (standard error)
    0.86 ± 0
    0.85 ± 0
    No statistical analyses for this end point

    Secondary: Rapid Assessment of Physical Activity (RAPA) at 26 weeks

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    End point title
    Rapid Assessment of Physical Activity (RAPA) at 26 weeks
    End point description
    The RAPA questionnaire assesses the level and intensity of physical activity of adult participants (pts).It contains 2 subscales:RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility).RAPA 1 contains 7 questions regarding the pts amount and intensity of physical activity,allowing each pts aerobic activity level to be categorized as sedentary,underactive,light activities,regular underactive,or active.RAPA 2 contains 2 questions regarding pts physical activities that increase strength and improve flexibility.Each pts strength and flexibility activity level is then categorized as neither, either or both strength and/or flexibility activity.Percentage of pts in each RAPA 1/2 category is presented and calculated by dividing the number of pts by the total number of pts analyzed, multiplied by 100.Analysis population included pts who were randomized,had at least 1 dose of study medication,evaluable RAPA data.Missing endpoints were imputed with LOCF method,using only post-baseline data.
    End point type
    Secondary
    End point timeframe
    up to 26 weeks
    End point values
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Number of subjects analysed
    331
    346
    Units: percentage of participants
    number (not applicable)
        RAPA 1, Sedentary (n=324, 339)
    2.2
    2.4
        RAPA 1, Underactive (n=324, 339)
    4.6
    6.2
        RAPA 1, Light activity (n=324, 339)
    21.9
    18
        RAPA 1, Regular underactive (n=324, 339)
    32.7
    27.1
        RAPA 1, Active (n=324, 339)
    38.6
    46.3
        RAPA 2, Neither strength/flexibility (n=331, 346)
    58.3
    53.8
        RAPA 2, Either strength/flexibility (n=331, 346)
    28.1
    30.6
        RAPA 2, Both strength/flexibility (n=331, 346)
    13.6
    15.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    LY2605541 + Insulin Lispro
    Reporting group description
    Includes participants that were randomized to receive LY2605541 plus Insulin Lispro. Participant-specific dose of LY2605541 was administered subcutaneously (SC) once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.

    Reporting group title
    Insulin Glargine + Insulin Lispro
    Reporting group description
    Includes participants that were randomized to receive Insulin Glargine plus Insulin Lispro. Participant-specific dose of Insulin Glargine was administered SC once daily at bedtime for 26 weeks. Participant-specific dose of Insulin Lispro was administered SC for preprandial and supplemental doses for 26 weeks.

    Serious adverse events
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Total subjects affected by serious adverse events
         subjects affected / exposed
    79 / 691 (11.43%)
    63 / 677 (9.31%)
         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)
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine benign neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ovarian cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    prostate cancer metastatic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal adenocarcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertensive crisis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intermittent claudication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subclavian artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    venous insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    knee arthroplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    medical device complication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         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
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic shock
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    drug hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sarcoidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         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
    postmenopausal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         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
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea exertional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory distress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    adjustment disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    panic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    catheterisation cardiac
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    acetabulum fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bone contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery restenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    excoriation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    medication error
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    skull fractured base
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    traumatic haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         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
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertensive heart disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nodal arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ventricular tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    carotid artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic hyperosmolar coma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemic unconsciousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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 / 691 (0.43%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         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
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    inner ear disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    panophthalmitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anal fistula
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bezoar
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    crohn's disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematochezia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         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
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    umbilical hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    drug-induced liver injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatic cirrhosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    blister
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus ureteric
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal failure acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal failure chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract obstruction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    hyperparathyroidism primary
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         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
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    exostosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mobility decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rhabdomyolysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal column stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spinal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic foot infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterococcal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incision site infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infected skin ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infectious mononucleosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    3 / 677 (0.44%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    rotavirus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subcutaneous abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    fluid overload
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (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
    18 / 691 (2.60%)
    12 / 677 (1.77%)
         occurrences causally related to treatment / all
    9 / 21
    7 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    LY2605541 + Insulin Lispro Insulin Glargine + Insulin Lispro
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    408 / 691 (59.04%)
    406 / 677 (59.97%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    benign neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    benign neoplasm of thyroid gland
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    chronic lymphocytic leukaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    melanocytic naevus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    skin papilloma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    thyroid adenoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    thyroid neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    Vascular disorders
    arterial disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    arteriosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    arteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    deep vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    essential hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    flushing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    3 / 677 (0.44%)
         occurrences all number
    1
    3
    hot flush
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    14 / 691 (2.03%)
    12 / 677 (1.77%)
         occurrences all number
    16
    12
    hypertensive crisis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    orthostatic hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    peripheral ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    varicose vein
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences all number
    0
    2
    Surgical and medical procedures
    abscess drainage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    anal fistula excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    appendicectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    atherectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    bone graft
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences all number
    0
    2
    cardiac ablation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    carpal tunnel decompression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    cataract operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    1 / 677 (0.15%)
         occurrences all number
    4
    1
    cholecystectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    coronary angioplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    coronary artery bypass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    craniotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    dental implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    dental operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    dental prosthesis placement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    endodontic procedure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    explorative laparotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    eye laser surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    fracture treatment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    gastrostomy tube insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    hip arthroplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    inguinal hernia repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    intervertebral disc operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences all number
    0
    2
    joint manipulation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    knee arthroplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    knee operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    laser therapy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    leg amputation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    ligament operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    malignant tumour excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    medical device implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    medical device removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    myringotomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    nail operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    nasal polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    oophorectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    open reduction of fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    osteosynthesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    ovarian operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    photocoagulation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    radical prostatectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    renal stone removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    retinal laser coagulation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    rotator cuff repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    sebaceous cyst excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    shoulder operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    skin graft
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    skin neoplasm excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    spinal fusion surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    stent placement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    tendon operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    tendon sheath incision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    toe amputation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    tooth extraction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    4 / 677 (0.59%)
         occurrences all number
    3
    4
    umbilical hernia repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    ureteral stent insertion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    ureteric calculus removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    uterine dilation and curettage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    varicose vein operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    wart excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    wound treatment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    7 / 677 (1.03%)
         occurrences all number
    0
    7
    chest discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    5 / 677 (0.74%)
         occurrences all number
    5
    6
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    face oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    fat tissue increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 691 (0.87%)
    16 / 677 (2.36%)
         occurrences all number
    8
    16
    feeling abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    feeling jittery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    gait disturbance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    generalised oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    hunger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    0 / 677 (0.00%)
         occurrences all number
    5
    0
    injection site bruising
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    4 / 677 (0.59%)
         occurrences all number
    2
    4
    injection site discolouration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    injection site erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences all number
    4
    0
    injection site hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    injection site hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    injection site induration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    injection site inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    injection site oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    injection site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    injection site pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    injection site swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    irritability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    nodule
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 691 (1.59%)
    26 / 677 (3.84%)
         occurrences all number
    11
    31
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 691 (1.16%)
    7 / 677 (1.03%)
         occurrences all number
    8
    7
    secretion discharge
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    temperature intolerance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    thirst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    3 / 677 (0.44%)
         occurrences all number
    0
    3
    Immune system disorders
    allergy to arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    contrast media allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    drug hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    food allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    multiple allergies
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    reaction to food additive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    3 / 677 (0.44%)
         occurrences all number
    5
    3
    Social circumstances
    menopause
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    breast mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    fibrocystic breast disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    menstruation irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    metrorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    posthitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    prostatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    testicular hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    uterine pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    vaginal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    allergic bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    2 / 677 (0.30%)
         occurrences all number
    5
    2
    atelectasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 691 (1.59%)
    12 / 677 (1.77%)
         occurrences all number
    11
    12
    dysphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    7 / 677 (1.03%)
         occurrences all number
    5
    7
    dyspnoea exertional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    3 / 677 (0.44%)
         occurrences all number
    0
    3
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    0 / 677 (0.00%)
         occurrences all number
    5
    0
    increased upper airway secretion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    interstitial lung disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    laryngeal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    3
    0
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    3 / 677 (0.44%)
         occurrences all number
    4
    3
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 691 (0.87%)
    6 / 677 (0.89%)
         occurrences all number
    6
    7
    pharyngeal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    pleural effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    pneumothorax
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    productive cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    pulmonary mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    pulmonary oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    respiratory disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    3
    2
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    sinus congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 691 (0.87%)
    5 / 677 (0.74%)
         occurrences all number
    6
    5
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    vocal cord inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    4 / 677 (0.59%)
         occurrences all number
    3
    4
    bipolar disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    confusional state
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    depressed mood
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    7 / 677 (1.03%)
         occurrences all number
    4
    7
    depressive symptom
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    homicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    4 / 677 (0.59%)
         occurrences all number
    4
    4
    libido decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    nervousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    sleep disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    stress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    suicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    hepatic function abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    hepatic steatosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences all number
    3
    0
    hepatomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    hyperbilirubinaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 691 (1.59%)
    2 / 677 (0.30%)
         occurrences all number
    12
    3
    angiogram
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    arteriogram coronary
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    arthroscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 691 (1.01%)
    1 / 677 (0.15%)
         occurrences all number
    7
    1
    biopsy skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    blood bilirubin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    blood creatine phosphokinase abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    9 / 677 (1.33%)
         occurrences all number
    2
    9
    blood creatinine increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    blood iron decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    blood pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    blood triglycerides increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    2 / 677 (0.30%)
         occurrences all number
    4
    2
    blood uric acid abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    blood uric acid increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    body temperature increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    bronchoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    catheterisation cardiac
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    colonoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    cystoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    ecg signs of myocardial ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    electrocardiogram abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    electrocardiogram change
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    endoscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    eosinophil count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    haematocrit decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    haematocrit increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    haemoglobin decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    haemoglobin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    heart rate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    heart rate irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    hepatic enzyme abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    2 / 677 (0.30%)
         occurrences all number
    4
    2
    liver function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    platelet count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    protein urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    qrs axis abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    red blood cell count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    renal function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    transaminases increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    ureteroscopy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    urine calcium
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    weight decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences all number
    3
    0
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    8 / 677 (1.18%)
         occurrences all number
    5
    8
    white blood cell count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    anaemia postoperative
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    ankle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    3 / 677 (0.44%)
         occurrences all number
    3
    3
    arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    1 / 677 (0.15%)
         occurrences all number
    2
    1
    brain contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    burns second degree
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    burns third degree
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    cartilage injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    chest injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    concussion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    8 / 677 (1.18%)
         occurrences all number
    6
    9
    drug administration error
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    3
    epicondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    excoriation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences all number
    3
    0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    femur fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    1 / 677 (0.15%)
         occurrences all number
    5
    1
    foreign body
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    foreign body in eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    hand fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    head injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    humerus fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    keratorhexis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    4 / 677 (0.59%)
         occurrences all number
    1
    4
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    lip injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    lower limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    medication error
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    muscle rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    7 / 677 (1.03%)
         occurrences all number
    3
    9
    optic nerve injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    patella fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    procedural pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    2 / 677 (0.30%)
         occurrences all number
    4
    3
    radius fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    spinal column injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    spinal compression fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    sunburn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    thermal burn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    tibia fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    upper limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    1 / 677 (0.15%)
         occurrences all number
    5
    1
    wrist fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    wrong technique in drug usage process
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    gilbert's syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    talipes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    type v hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    Cardiac disorders
    angina unstable
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    aortic valve sclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    atrial flutter
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    atrioventricular block
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    bradycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    bundle branch block left
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    bundle branch block right
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    cardiac discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    cardiac disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    cardiac failure congestive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    1 / 677 (0.15%)
         occurrences all number
    4
    1
    cardiomegaly
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    coronary artery disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    left ventricular failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    left ventricular hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    0 / 677 (0.00%)
         occurrences all number
    2
    0
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    palpitations
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    1 / 677 (0.15%)
         occurrences all number
    4
    1
    pericardial effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    2
    sinus arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    3 / 677 (0.44%)
         occurrences all number
    0
    3
    supraventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    3 / 677 (0.44%)
         occurrences all number
    1
    3
    Nervous system disorders
    ageusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    amnesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    burning sensation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    carotid artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 691 (1.45%)
    1 / 677 (0.15%)
         occurrences all number
    11
    1
    cerebral microangiopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    decreased vibratory sense
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    diabetic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    5 / 677 (0.74%)
         occurrences all number
    5
    5
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 691 (1.30%)
    10 / 677 (1.48%)
         occurrences all number
    11
    10
    dysgeusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    1 / 677 (0.15%)
         occurrences all number
    1
    1
    dyskinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    guillain-barre syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 691 (1.74%)
    19 / 677 (2.81%)
         occurrences all number
    12
    20
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 691 (1.01%)
    7 / 677 (1.03%)
         occurrences all number
    8
    9
    iiird nerve paralysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    intercostal neuralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    lethargy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences all number
    3
    0
    memory impairment
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 691 (0.72%)
    3 / 677 (0.44%)
         occurrences all number
    5
    3
    monomelic amyotrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    mononeuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    nerve compression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    neuropathy peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    5 / 677 (0.74%)
         occurrences all number
    3
    5
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 691 (0.58%)
    3 / 677 (0.44%)
         occurrences all number
    7
    3
    parkinson's disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    petit mal epilepsy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    polyneuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    presyncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    radiculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    radiculopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    restless legs syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    sciatica
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    6 / 677 (0.89%)
         occurrences all number
    1
    6
    sinus headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences all number
    0
    2
    somnolence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    2 / 677 (0.30%)
         occurrences all number
    1
    2
    tension headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    2 / 677 (0.30%)
         occurrences all number
    0
    2
    transient ischaemic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    tremor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 691 (0.43%)
    0 / 677 (0.00%)
         occurrences all number
    3
    0
    trigeminal neuralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    viith nerve paralysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    vertebrobasilar insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 691 (0.29%)
    2 / 677 (0.30%)
         occurrences all number
    2
    2
    bone marrow oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    eosinophilia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    increased tendency to bruise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    iron deficiency anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    leukocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    lymphadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 691 (0.14%)
    0 / 677 (0.00%)
         occurrences all number
    1
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    lymphadenopathy mediastinal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 691 (0.00%)
    1 / 677 (0.15%)
         occurrences all number
    0
    1
    microcytic anaemia