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    Clinical Trial Results:
    The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study

    Summary
    EudraCT number
    		 2011-001261-40
    Trial protocol
    		 DE   AT   IT  
    Global end of trial date
    07 Jun 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    I2R-MC-BIAN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01481779
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Eli Lilly and Company: 12146
    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
    07 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that glycemic control, as measured by HbA1c at 26 weeks, for insulin peglispro was noninferior compared with insulin glargine when each was combined with preprandial insulin lispro in patients with type 1 diabetes mellitus (T1DM).
    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
    06 Jan 2012
    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
    France: 37
    Country: Number of subjects enrolled
    United States: 130
    Country: Number of subjects enrolled
    Mexico: 40
    Country: Number of subjects enrolled
    Poland: 41
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Japan: 91
    Country: Number of subjects enrolled
    Italy: 19
    Worldwide total number of subjects
    455
    EEA total number of subjects
    174
    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)
    439
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study included a 2-3 week screening period, a 78-week treatment period (26-week primary endpoint assessment, followed by a 52-week extension), and a 4-week post treatment follow-up period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY2605541 + Insulin Lispro
    Arm description
    		 LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2605541
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

    Arm title
    		 Glargine + Insulin Lispro
    Arm description
    		 Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks.

    Investigational medicinal product name
    Insulin Lispro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

    Number of subjects in period 1
    		LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Started
    295
    160
    Received at Least 1 Dose of Study Drug
    294
    159
    Completed
    225
    132
    Not completed
    70
    28
         Consent withdrawn by subject
    26
    13
         Physician decision
    13
    4
         Adverse event, non-fatal
    23
    5
         Sponsor Decision
    3
    1
         Lost to follow-up
    3
    2
         Protocol deviation
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2605541 + Insulin Lispro
    Reporting group description
    		 LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

    Reporting group title
    Glargine + Insulin Lispro
    Reporting group description
    		 Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

    Reporting group values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro Total
    Number of subjects
    		 295 160 455
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.68 ± 12.93 38.91 ± 14.1 -
    Gender, Male/Female
    Units:
        Female
    		 157 73 230
        Male
    		 138 87 225
    Region of Enrollment
    Units: Subjects
        France
    		 23 14 37
        United States
    		 85 45 130
        Mexico
    		 25 15 40
        Poland
    		 27 14 41
        Austria
    		 7 4 11
        Russian Federation
    		 11 9 20
        Germany
    		 45 21 66
        Japan
    		 60 31 91
        Italy
    		 12 7 19
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 33 16 49
        Not Hispanic or Latino
    		 153 85 238
        Unknown or Not Reported
    		 109 59 168
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 6 3 9
        Asian
    		 63 31 94
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 5 0 5
        White
    		 221 125 346
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    LY2605541 + Insulin Lispro
    Reporting group description
    		 LY2605541 titrated based on blood glucose readings, administered by subcutaneous (SC) injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

    Reporting group title
    Glargine + Insulin Lispro
    Reporting group description
    		 Glargine dose titrated based on blood glucose readings, administered by SC injection via pen device once daily at bedtime for 78 weeks in combination with Insulin Lispro. Insulin Lispro dose titrated based on blood glucose readings, administered by SC injection via pen device at meal times for 78 weeks.

    Primary: Hemoglobin A1c (HbA1c) at 26 weeks

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    End point title
    		 Hemoglobin A1c (HbA1c) at 26 weeks [1]
    End point description
    HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect. Analysis Population Description: 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
    26 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned or conducted for this endpoint.
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    153
    Units: percentage of HbA1c
        least squares mean (standard error)
    7.06 ± 0.04
    7.43 ± 0.06
    No statistical analyses for this end point

    Secondary: Hemoglobin A1c (HbA1c)

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    End point title
    		 Hemoglobin A1c (HbA1c)
    End point description
    HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects. Analysis Population Description: 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
    52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    153
    Units: percentage of HbA1c
    least squares mean (standard error)
        Week 52
    7.3 ± 0.05
    7.55 ± 0.06
        Week 78
    7.43 ± 0.05
    7.7 ± 0.07
    No statistical analyses for this end point

    Secondary: Percentage of participants with hemoglobin A1c (HbA1c) less than 7.0% or less than or equal to 6.5% using last observation carried forward (LOCF)

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    End point title
    		 Percentage of participants with hemoglobin A1c (HbA1c) less than 7.0% or less than or equal to 6.5% using last observation carried forward (LOCF)
    End point description
    HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100. Analysis Population Description: 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
    26 weeks and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    153
    Units: percentage of participants
    number (not applicable)
        HbA1c ≤6.5%, Week 26
    28.6
    13.7
        HbA1c ≤6.5%, Week 52
    23.3
    13.1
        HbA1c ≤6.5%, Week 78
    20.2
    13.1
        HbA1c <7.0%, Week 26
    44.9
    27.5
        HbA1c <7.0%, Week 52
    37.3
    28.1
        HbA1c <7.0%, Week 78
    34.5
    22.9
    No statistical analyses for this end point

    Secondary: Change from baseline in Hemoglobin A1c (HbA1c)

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    End point title
    		 Change from baseline in Hemoglobin A1c (HbA1c)
    End point description
    HbA1c is a test that measures a participant’s average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects. Analysis Population Description: 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
    Baseline, 26 weeks, 52 weeks, 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    153
    Units: percentage of HbA1c
    least squares mean (standard error)
        Week 26
    -0.69 ± 0.04
    -0.33 ± 0.06
        Week 52
    -0.46 ± 0.05
    -0.21 ± 0.06
        Week 78
    -0.33 ± 0.05
    -0.05 ± 0.07
    No statistical analyses for this end point

    Secondary: Proportion of participants with hemoglobin A1c (HbA1c) less than 7.0% without nocturnal hypoglycemia

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    End point title
    		 Proportion of participants with hemoglobin A1c (HbA1c) less than 7.0% without nocturnal hypoglycemia
    End point description
    Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter [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, then multiplying by 100. Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    26 weeks and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    153
    Units: percentage of participants
    number (not applicable)
        Week 26
    3.8
    2
        Week 52
    2.1
    0.7
        Week 78
    1
    0
    No statistical analyses for this end point

    Secondary: Total hypoglycemia rates (Adjusted by 30 days)

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    End point title
    		 Total hypoglycemia rates (Adjusted by 30 days)
    End point description
    Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. Analysis Population Description: 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 and Baseline through 52 weeks and Baseline through 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    293
    159
    Units: episodes/participant/30 days
    arithmetic mean (standard error)
        Baseline-Week 26
    16.01 ± 0.44
    12.43 ± 0.55
        Baseline-Week 52
    14.84 ± 0.42
    11.75 ± 0.55
        Baseline-Week 78
    14.33 ± 0.42
    11.43 ± 0.55
    No statistical analyses for this end point

    Secondary: Percentage of participants with total hypoglycemia events

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    End point title
    		 Percentage of participants with total hypoglycemia events
    End point description
    Hypoglycemic events are defined as events that 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, then multiplying by 100. Analysis Population Description: 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 and Baseline through 52 weeks and Baseline through 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    294
    159
    Units: percentage of participants
    number (not applicable)
        Baseline-Week 26
    99
    96.9
        Baseline-Week 52
    99
    96.9
        Baseline-Week 78
    99
    96.9
    No statistical analyses for this end point

    Secondary: Percentage of participants with nocturnal hypoglycemic Events

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    End point title
    		 Percentage of participants with nocturnal hypoglycemic Events
    End point description
    Hypoglycemic episodes are defined as an event that 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, then multiplying by 100. Analysis Population Description: 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 and Baseline through 52 weeks and Baseline through 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    294
    159
    Units: percentage of participants
    number (not applicable)
        Baseline-Week 26
    87.4
    90.6
        Baseline-Week 52
    91.5
    91.8
        Baseline-Week 78
    93.5
    92.5
    No statistical analyses for this end point

    Secondary: Nocturnal hypoglycemia rates (Adjusted by 30 days)

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    End point title
    		 Nocturnal hypoglycemia rates (Adjusted by 30 days)
    End point description
    Hypoglycemic episodes are defined as events that 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. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants. Analysis Population Description: 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 and Baseline through 52 weeks and Baseline through 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    293
    159
    Units: episodes/participant/30 days
    arithmetic mean (standard error)
        Baseline-Week 26
    1.69 ± 0.12
    2.66 ± 0.19
        Baseline-Week 52
    1.63 ± 0.11
    2.45 ± 0.19
        Baseline-Week 78
    1.58 ± 0.11
    2.28 ± 0.17
    No statistical analyses for this end point

    Secondary: Fasting serum glucose (FSG) by laboratory measurement

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    End point title
    		 Fasting serum glucose (FSG) by laboratory measurement
    End point description
    LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    285
    152
    Units: mg/dL
    least squares mean (standard error)
        Week 26
    138.22 ± 3.8
    160.35 ± 5.06
        Week 52
    146.55 ± 4.42
    164.28 ± 5.72
        Week 78
    144.64 ± 4.53
    164.78 ± 5.81
    No statistical analyses for this end point

    Secondary: Fasting blood glucose (FBG) intra-participant variability

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    End point title
    		 Fasting blood glucose (FBG) intra-participant variability
    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 treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    282
    153
    Units: mg/dL
    least squares mean (standard error)
        Week 26
    52.49 ± 1.79
    59.25 ± 2.43
        Week 52
    53.44 ± 1.85
    58.15 ± 2.43
        Week 78
    54.87 ± 2.2
    60.66 ± 2.79
    No statistical analyses for this end point

    Secondary: 9 point self-monitored blood glucose (SMBG)

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    End point title
    		 9 point self-monitored blood glucose (SMBG)
    End point description
    9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. 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 pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    271
    143
    Units: mg/dL
    least squares mean (standard error)
        Pre-morning meal, Week 26 (n=271, 143)
    158.58 ± 3.82
    144.4 ± 5.2
        Pre-morning meal, Week 52 (n=271, 143)
    160.89 ± 4.13
    152.55 ± 5.38
        Pre-morning meal, Week 78 (n=271, 143)
    163.09 ± 4.66
    153.38 ± 5.99
        2 hours post-morning meal, Week 26 (n=245, 125)
    172.39 ± 4.59
    165.53 ± 6.44
        2 hours post-morning meal, Week 52 (n=245, 125)
    176.32 ± 5.61
    168.38 ± 7.47
        2 hours post-morning meal, Week 78 (n=245, 125)
    183.64 ± 6.23
    190.54 ± 7.91
        Pre-midday meal, Week 26 (n=264, 140)
    136.21 ± 3.92
    153.12 ± 5.33
        Pre-midday meal, Week 52 (n=264, 140)
    142.82 ± 4.27
    149.78 ± 5.66
        Pre-midday meal, Week 78 (n=264, 140)
    150.83 ± 4.9
    154.56 ± 6.33
        2 hours post-midday meal, Week 26 (n=244, 122)
    157.17 ± 4.78
    164.75 ± 6.69
        2 hours post-midday meal, Week 52 (n=244, 122)
    159.59 ± 5.11
    168.83 ± 6.94
        2 hours post-midday meal, Week 78 (n=244, 122)
    154.46 ± 5.76
    175.52 ± 7.51
        Pre-evening meal, Week 26 (n=266, 143)
    153.2 ± 4.29
    168.08 ± 5.75
        Pre-evening meal, Week 52 (n=266, 143)
    153.01 ± 5.17
    183.18 ± 6.81
        Pre-evening meal, Week 78 (n=266, 143)
    149.89 ± 4.92
    174.5 ± 6.17
        2 hours post-evening meal, Week 26 (n=232, 126)
    149.74 ± 5.17
    191.99 ± 7.2
        2 hours post-evening meal, Week 52 (n=232, 126)
    157.81 ± 6.79
    198.1 ± 9.06
        2 hours post-evening meal, Week 78 (n=232, 126)
    163.27 ± 6.07
    189.43 ± 7.75
        Bedtime, Week 26 (n=250, 137)
    151.66 ± 4.15
    176.17 ± 5.63
        Bedtime, Week 52 (n=250, 137)
    167.35 ± 5.33
    182.08 ± 7.11
        Bedtime, Week 78 (n=250, 137)
    165.63 ± 5.37
    185.45 ± 6.74
        0300 hours, Week 26 (n=219, 116)
    159.73 ± 5.3
    163.18 ± 7.5
        0300 hours, Week 52 (n=219, 116)
    157.52 ± 6.06
    148.26 ± 8.36
        0300 hours, Week 78 (n=219, 116)
    165.82 ± 7.19
    170.35 ± 9.02
        Pre-morning meal next day, Week 26 (n=260, 138)
    149.94 ± 3.74
    143.89 ± 5.1
        Pre-morning meal next day, Week 52 (n=260, 138)
    155.79 ± 4.24
    145.55 ± 5.59
        Pre-morning meal next day, Week 78 (n=260, 138)
    156.87 ± 4.8
    152.63 ± 6.11
    No statistical analyses for this end point

    Secondary: 0300-hour blood glucose (BG) to fasting blood (FBG) glucose excursion

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    End point title
    		 0300-hour blood glucose (BG) to fasting blood (FBG) glucose excursion
    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 treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    209
    112
    Units: mg/dL
    least squares mean (standard error)
        Week 26
    -9.92 ± 6.24
    -14.08 ± 8.75
        Week 52
    -6.15 ± 6.91
    -9.02 ± 9.58
        Week 78
    -10.82 ± 8.25
    -28.94 ± 10.5
    No statistical analyses for this end point

    Secondary: Change from baseline in body weight

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    End point title
    		 Change from baseline in body weight
    End point description
    LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect. Analysis Population Description: 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 and 26 weeks and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    154
    Units: kilograms (kg)
    least squares mean (standard error)
        Week 26
    -1.17 ± 0.2
    0.71 ± 0.27
        Week 52
    -1.22 ± 0.25
    1 ± 0.33
        Week 78
    -0.93 ± 0.28
    1.04 ± 0.37
    No statistical analyses for this end point

    Secondary: Basal, bolus, and total insulin dose

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    End point title
    		 Basal, bolus, and total insulin dose
    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 MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    282
    156
    Units: units/kg/day
    least squares mean (standard error)
        Basal Insulin, Week 26 (n=239, 127)
    0.4 ± 0.01
    0.34 ± 0.01
        Basal Insulin, Week 52 (n=239, 127)
    0.4 ± 0.01
    0.34 ± 0.01
        Basal Insulin, Week 78 (n=239, 127)
    0.41 ± 0.01
    0.35 ± 0.01
        Bolus Insulin, Week 26 (n=280, 153)
    0.37 ± 0.01
    0.46 ± 0.02
        Bolus Insulin, Week 52 (n=280, 153)
    0.38 ± 0.01
    0.47 ± 0.02
        Bolus Insulin, Week 78 (n=280, 153)
    0.37 ± 0.02
    0.48 ± 0.02
        Total Insulin, Week 26 (n=282, 156)
    0.73 ± 0.02
    0.78 ± 0.02
        Total Insulin, Week 52 (n=282, 156)
    0.74 ± 0.02
    0.79 ± 0.03
        Total Insulin, Week 78 (n=282, 156)
    0.75 ± 0.02
    0.8 ± 0.03
    No statistical analyses for this end point

    Secondary: Lipid profile

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    End point title
    		 Lipid profile
    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), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    288
    152
    Units: mg/dL
    least squares mean (standard error)
        Cholesterol, Week 26
    191.86 ± 1.63
    187.93 ± 2.19
        Cholesterol, Week 52
    190.72 ± 1.59
    188.65 ± 2.1
        Cholesterol, Week 78
    191.78 ± 1.86
    190.06 ± 2.39
        HDL-C, Week 26
    61.87 ± 0.59
    62.75 ± 0.8
        HDL-C, Week 52
    61.01 ± 0.56
    61.46 ± 0.74
        HDL-C, Week 78
    60.77 ± 0.66
    61.97 ± 0.85
        LDL-C, Week 26
    108.85 ± 1.33
    108.31 ± 1.79
        LDL-C, Week 52
    109.4 ± 1.39
    109.74 ± 1.84
        LDL-C, Week 78
    109.62 ± 1.62
    110.35 ± 2.09
        Triglycerides, Week 26
    109.64 ± 3.89
    85.35 ± 5.24
        Triglycerides, Week 52
    105.17 ± 3.64
    87.94 ± 4.8
        Triglycerides, Week 78
    110.8 ± 4.78
    88.96 ± 6.14
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Change in anti-LY2605541 antibodies

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    End point title
    		 Percentage of Participants with Change in anti-LY2605541 antibodies
    End point description
    The percentage 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 Description: Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline. Missing endpoints were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    288
    153
    Units: percentage of participants
    number (not applicable)
        Week 26 (n=288, 152)
    30.6
    15.8
        Week 52 (n=288, 152)
    29.9
    17.1
        Week 78 (n=288, 153)
    26.4
    13.1
    No statistical analyses for this end point

    Secondary: Insulin Treatment Satisfaction Questionnaire (ITSQ)

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    End point title
    		 Insulin Treatment Satisfaction Questionnaire (ITSQ)
    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, and 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 (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline value of the dependent variable as a covariate. 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
    26 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    273
    149
    Units: units on a scale
        least squares mean (standard error)
    72.43 ± 0.69
    73.91 ± 0.94
    No statistical analyses for this end point

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

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    End point title
    		 European Quality of Life-5 Dimension (EQ-5D)
    End point description
    The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (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 and stratification factors (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline EQ-5D score as a covariate. Analysis Population Description: 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
    26 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    277
    150
    Units: units on a scale
        least squares mean (standard error)
    0.92 ± 0.01
    0.91 ± 0.01
    No statistical analyses for this end point

    Secondary: Low Blood Sugar Survey (LBSS)

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    End point title
    		 Low Blood Sugar Survey (LBSS)
    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, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect. Analysis Population Description: 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 and 52 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    287
    151
    Units: units on a scale
    least squares mean (standard error)
        Week 26
    28.09 ± 0.7
    27.09 ± 0.95
        Week 52
    27.76 ± 0.77
    27 ± 1.01
        Week 78
    27.68 ± 0.91
    27.14 ± 1.18
    No statistical analyses for this end point

    Secondary: Rapid Assessment of Physical Activity (RAPA)

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    End point title
    		 Rapid Assessment of Physical Activity (RAPA)
    End point description
    RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant’s amount and intensity of physical activity, allowing each participant’s aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants’ physical activities that increase strength and improve flexibility. Each participant’s strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.
    End point type
    Secondary
    End point timeframe
    26 weeks and 78 weeks
    End point values
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Number of subjects analysed
    98 [2]
    57 [3]
    Units: percentage of participants
    number (not applicable)
        RAPA 1, Sedentary, Week 26 (n=98, 57)
    1
    0
        RAPA 1, Sedentary, Week 78 (n=80, 51)
    1.3
    0
        RAPA 1, Underactive, Week 26 (n=98, 57)
    3.1
    3.5
        RAPA 1, Underactive, Week 78 (n=80, 51)
    3.8
    2
        RAPA 1, Light activity, Week 26 (n=98, 57)
    13.3
    10.5
        RAPA 1, Light activity, Week 78 (n=80, 51)
    7.5
    13.7
        RAPA 1, Regular underactive, Week 26 (n=98, 57)
    24.5
    29.8
        RAPA 1, Regular underactive, Week 78 (n=80, 51)
    31.3
    29.4
        RAPA 1, Active, Week 26 (n=98, 57)
    58.2
    56.1
        RAPA 1, Active, Week 78 (n=80, 51)
    56.3
    54.9
        RAPA 2, Neither strength/flex, Week 26 (n=98, 57)
    35.7
    43.9
        RAPA 2, Neither strength/flex, Week 78 (n=81, 51)
    37
    47.1
        RAPA 2, Either strength/flex, Week 26 (n=98, 57)
    30.6
    35.1
        RAPA 2, Either strength/flex, Week 78 (n=81, 51)
    33.3
    29.4
        RAPA 2, Both strength/flex, Week 26 (n=98, 57)
    33.7
    21.1
        RAPA 2, Both strength/flex, Week 78 (n=81, 51)
    29.6
    23.5
    Notes
    [2] - Participants who were randomized, had at least 1 dose of study medication,& had evaluable RAPA data.
    [3] - Missing endpoints were imputed with the LOCF method, using only post-baseline data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    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
    		 -

    Reporting group title
    Glargine + Insulin Lispro
    Reporting group description
    		 -

    Serious adverse events
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Total subjects affected by serious adverse events
         subjects affected / exposed
    67 / 294 (22.79%)
    25 / 159 (15.72%)
         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)
    Acute myeloid leukaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    benign bone neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (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 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cervix carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fibroadenoma of breast
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    uterine leiomyoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    intermittent claudication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         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 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    peripheral artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    hysterectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    toe amputation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         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 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    cervical polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    menorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ovarian cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (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
    Alcohol poisoning
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clavicle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    incorrect dose administered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intentional overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (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
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiomyopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    complicated migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemic coma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    sudden hearing loss
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tympanic membrane perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    faeces pale
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    impaired gastric emptying
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    hepatic function abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    skin ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    renal failure acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar spinal stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscle contracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spondylolisthesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic gangrene
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infectious mononucleosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    post procedural sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pseudomonas infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    staphylococcal sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    45 / 294 (15.31%)
    13 / 159 (8.18%)
         occurrences causally related to treatment / all
    61 / 73
    17 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ketoacidosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    metabolic disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 LY2605541 + Insulin Lispro Glargine + Insulin Lispro
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    256 / 294 (87.07%)
    112 / 159 (70.44%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    angiomyolipoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    eye naevus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    haemangioma of liver
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    lipoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    thyroid neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    uterine leiomyoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    aortic arteriosclerosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    deep vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    hyperaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 294 (3.40%)
    1 / 159 (0.63%)
         occurrences all number
    10
    1
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    phlebitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    thrombophlebitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    varicose vein
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    venous thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    vessel perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    abortion induced
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    blepharoplasty
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    cardiac ablation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    cataract operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Colon polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    cyst removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    dental care
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    dental implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    diabetes mellitus management
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    endodontic procedure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    face lift
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hysterectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    inguinal hernia repair
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    liposuction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    mass excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    mole excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    oral surgery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    retinal laser coagulation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    4
    0
    tendon sheath incision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    3
    thrombosis prophylaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    toe operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tooth extraction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    4 / 159 (2.52%)
         occurrences all number
    4
    4
    tumour excision
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Pregnancy, puerperium and perinatal conditions
    pregnancy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    4
    0
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    drug intolerance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    fat tissue increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 294 (2.04%)
    2 / 159 (1.26%)
         occurrences all number
    6
    2
    feeling cold
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    induration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    infusion site extravasation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    injection site atrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    injection site bruising
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    injection site discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    injection site haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    2
    injection site hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 294 (2.72%)
    0 / 159 (0.00%)
         occurrences all number
    9
    0
    injection site mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    injection site oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    injection site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    injection site pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    injection site reaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    6
    0
    injection site swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    7
    0
    instillation site reaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    local swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 294 (2.72%)
    3 / 159 (1.89%)
         occurrences all number
    8
    3
    vessel puncture site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Immune system disorders
    allergy to animal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    allergy to arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    house dust allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    2 / 159 (1.26%)
         occurrences all number
    3
    3
    Social circumstances
    menopause
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    tobacco user
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    amenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    breast mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    dysmenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    3 / 159 (1.89%)
         occurrences all number
    6
    4
    fibrocystic breast disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    menstruation irregular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    ovarian cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    pelvic pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    polymenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    pruritus genital
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    testicular pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    acute lung injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    bronchitis chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 294 (3.06%)
    5 / 159 (3.14%)
         occurrences all number
    12
    6
    dysphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    haemoptysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    nasal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 294 (2.38%)
    4 / 159 (2.52%)
         occurrences all number
    7
    4
    pleural effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    1 / 159 (0.63%)
         occurrences all number
    3
    1
    sinus congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    sneezing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    throat irritation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    3
    Psychiatric disorders
    alcohol abuse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    5 / 159 (3.14%)
         occurrences all number
    2
    5
    drug dependence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    emotional disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    2 / 159 (1.26%)
         occurrences all number
    4
    2
    mental disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    mood altered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    suicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    gallbladder polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    hepatic steatosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    1 / 159 (0.63%)
         occurrences all number
    4
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 294 (4.08%)
    1 / 159 (0.63%)
         occurrences all number
    20
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 294 (2.72%)
    1 / 159 (0.63%)
         occurrences all number
    10
    1
    bacterial test positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    biopsy breast
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    blood bicarbonate decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    blood bilirubin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    1 / 159 (0.63%)
         occurrences all number
    4
    1
    blood triglycerides increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    electrocardiogram repolarisation abnormality
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    helicobacter test positive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 294 (2.04%)
    1 / 159 (0.63%)
         occurrences all number
    6
    1
    liver function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    4
    0
    transaminases increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    weight decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 294 (2.04%)
    1 / 159 (0.63%)
         occurrences all number
    6
    1
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    6 / 159 (3.77%)
         occurrences all number
    4
    6
    Injury, poisoning and procedural complications
    animal bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    ankle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    avulsion fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    chillblains
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    1 / 159 (0.63%)
         occurrences all number
    3
    1
    corneal abrasion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    epicondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    excoriation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    3 / 159 (1.89%)
         occurrences all number
    3
    3
    fracture displacement
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    gastrointestinal disorder postoperative
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hand fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    head injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    intentional overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    joint dislocation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    2 / 159 (1.26%)
         occurrences all number
    5
    2
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    meniscus injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    muscle contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    muscle injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    muscle rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    nail injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    patella fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    post procedural complication
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    procedural nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    procedural pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    rib fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    2
    road traffic accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    tibia fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tooth fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    traumatic ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    wrist fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    wrong drug administered
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    Congenital, familial and genetic disorders
    phimosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    left ventricular hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    palpitations
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    sick sinus syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    Nervous system disorders
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    cervicobrachial syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    diabetic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    3
    1
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    4 / 159 (2.52%)
         occurrences all number
    6
    4
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 294 (6.12%)
    10 / 159 (6.29%)
         occurrences all number
    27
    13
    hypertonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hypokinesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    nerve compression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    restless legs syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    sciatica
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    sinus headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    somnolence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    tension headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    2 / 159 (1.26%)
         occurrences all number
    3
    2
    iron deficiency anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    lymphadenitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    microcytic anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    pancytopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    vertigo positional
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    2 / 159 (1.26%)
         occurrences all number
    5
    2
    conjunctivitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    diabetic retinal oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    diabetic retinopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 294 (2.38%)
    0 / 159 (0.00%)
         occurrences all number
    8
    0
    dry eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    eye haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    eye pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    keratitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    macular degeneration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    macular oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    pingueculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    retinal aneurysm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    retinopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    vision blurred
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    visual acuity reduced
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    vitreous haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    abdominal distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    1 / 159 (0.63%)
         occurrences all number
    5
    2
    abdominal pain lower
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    3 / 159 (1.89%)
         occurrences all number
    5
    3
    anal polyp
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Coeliac disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    1 / 159 (0.63%)
         occurrences all number
    3
    1
    dental caries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    13 / 294 (4.42%)
    3 / 159 (1.89%)
         occurrences all number
    15
    3
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    4
    0
    enteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    flatulence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    food poisoning
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    4 / 159 (2.52%)
         occurrences all number
    4
    4
    gastric mucosa erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    gastric ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 294 (2.38%)
    3 / 159 (1.89%)
         occurrences all number
    8
    3
    gastritis erosive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 294 (2.04%)
    1 / 159 (0.63%)
         occurrences all number
    7
    1
    haematochezia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    haemorrhoids
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    0
    2
    melanosis coli
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 294 (2.72%)
    4 / 159 (2.52%)
         occurrences all number
    9
    4
    pancreatic insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    paraesthesia oral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tooth disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tooth loss
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    toothache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    1 / 159 (0.63%)
         occurrences all number
    4
    1
    umbilical hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 294 (2.38%)
    3 / 159 (1.89%)
         occurrences all number
    9
    3
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    blister
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    dermal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    dermatitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    dermatitis contact
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    eczema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    2 / 159 (1.26%)
         occurrences all number
    3
    2
    erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    haemorrhage subcutaneous
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hyperkeratosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    ingrowing nail
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    lipodystrophy acquired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    17 / 294 (5.78%)
    1 / 159 (0.63%)
         occurrences all number
    24
    1
    lipohypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    45 / 294 (15.31%)
    0 / 159 (0.00%)
         occurrences all number
    66
    0
    neurodermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    night sweats
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    panniculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    petechiae
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    1 / 159 (0.63%)
         occurrences all number
    3
    1
    skin mass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    skin ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    2 / 159 (1.26%)
         occurrences all number
    2
    3
    swelling face
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    3 / 159 (1.89%)
         occurrences all number
    4
    3
    urticaria chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    albuminuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    2
    cystitis noninfective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    microalbuminuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    4
    0
    nephrolithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    neurogenic bladder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    polyuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    renal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    urinary incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    urinary retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Endocrine disorders
    autoimmune thyroiditis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    basedow's disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    goitre
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    thyroiditis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    4 / 159 (2.52%)
         occurrences all number
    2
    4
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    15 / 294 (5.10%)
    7 / 159 (4.40%)
         occurrences all number
    17
    7
    bone formation increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    exostosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    groin pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hypercreatinaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    intervertebral disc disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    joint swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    muscle atrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    muscular weakness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    3 / 159 (1.89%)
         occurrences all number
    1
    3
    myositis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    neck pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 294 (2.38%)
    3 / 159 (1.89%)
         occurrences all number
    8
    3
    periarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    polyarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    spondylolisthesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tendon pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tendonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    trigger finger
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    Infections and infestations
    acarodermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    acute sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    acute tonsillitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    anal abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    bacterial infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    bacterial rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 294 (3.74%)
    4 / 159 (2.52%)
         occurrences all number
    12
    4
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    2 / 159 (1.26%)
         occurrences all number
    0
    4
    conjunctivitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    cystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 294 (3.06%)
    3 / 159 (1.89%)
         occurrences all number
    10
    3
    ear infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    enterobiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    eye infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 294 (3.74%)
    8 / 159 (5.03%)
         occurrences all number
    11
    9
    gastroenteritis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    5 / 159 (3.14%)
         occurrences all number
    4
    6
    gastrointestinal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    genital infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    gingivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    hand-foot-and-mouth disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    helicobacter gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    herpes virus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    hordeolum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    2
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    25 / 294 (8.50%)
    14 / 159 (8.81%)
         occurrences all number
    32
    14
    laryngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    lice infestation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    localised infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    mastitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    nail infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    92 / 294 (31.29%)
    38 / 159 (23.90%)
         occurrences all number
    152
    61
    onychomycosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    oral fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    oral herpes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    2
    1
    otitis externa
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    otitis media
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    2 / 159 (1.26%)
         occurrences all number
    2
    2
    papilloma viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    periodontitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    13 / 294 (4.42%)
    7 / 159 (4.40%)
         occurrences all number
    19
    9
    pharyngitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    1 / 159 (0.63%)
         occurrences all number
    3
    4
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    2 / 159 (1.26%)
         occurrences all number
    3
    2
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    pulpitis dental
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    5
    1
    purulence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    0 / 159 (0.00%)
         occurrences all number
    4
    0
    sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 294 (2.38%)
    4 / 159 (2.52%)
         occurrences all number
    8
    5
    staphylococcal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    staphylococcal osteomyelitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    tinea infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tinea pedis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tooth abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    3 / 159 (1.89%)
         occurrences all number
    1
    4
    tooth infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    tracheitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    2
    tracheobronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    13 / 294 (4.42%)
    12 / 159 (7.55%)
         occurrences all number
    22
    17
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    15 / 294 (5.10%)
    8 / 159 (5.03%)
         occurrences all number
    17
    14
    vaginal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    viral rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    1 / 159 (0.63%)
         occurrences all number
    1
    1
    wound infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    central obesity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 294 (1.70%)
    0 / 159 (0.00%)
         occurrences all number
    5
    0
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    dyslipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    2 / 159 (1.26%)
         occurrences all number
    3
    2
    electrolyte imbalance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 294 (0.00%)
    1 / 159 (0.63%)
         occurrences all number
    0
    1
    fluid retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 294 (0.68%)
    1 / 159 (0.63%)
         occurrences all number
    3
    1
    hyperalbuminaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hypercholesterolaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 294 (1.36%)
    2 / 159 (1.26%)
         occurrences all number
    4
    2
    hyperglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 294 (1.02%)
    0 / 159 (0.00%)
         occurrences all number
    3
    0
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    hyperuricaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    1
    0
    iron deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    0 / 159 (0.00%)
         occurrences all number
    2
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 294 (0.34%)
    2 / 159 (1.26%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Sep 2011
    Secondary objective related to safety measures was added. Discontinuation criteria was revised. Statistical analysis plan was updated. Information for the blood glucose meter was added.
    07 Sep 2012
    Added additional information to clarify insulin dosing plans. Statistical Analysis plan was updated.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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