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    Clinical Trial Results:
    A Comparison of LY2605541 versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with 2 or more Oral Antihyperglycemic Medications: An Open-Label, Randomized Study.

    Summary
    EudraCT number
    2012-003941-13
    Trial protocol
    HU   CZ   ES   DE   PL  
    Global end of trial date
    28 May 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-BIAK
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01790438
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 12143
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States,
    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
    28 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare LY2605541 and human insulin NPH using the following measures for participants treated for up to 26 weeks: •Change in participants' overall blood sugar control •The number of night time low blood sugar episodes •The number of participants that reach blood sugar targets without low night time blood sugar episodes •The total number of low blood sugar episodes reported
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Mar 2013
    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
    Spain: 45
    Country: Number of subjects enrolled
    United States: 172
    Country: Number of subjects enrolled
    Argentina: 45
    Country: Number of subjects enrolled
    Canada: 38
    Country: Number of subjects enrolled
    Czech Republic: 35
    Country: Number of subjects enrolled
    Germany: 45
    Country: Number of subjects enrolled
    Hungary: 35
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 73
    Country: Number of subjects enrolled
    Mexico: 32
    Country: Number of subjects enrolled
    Poland: 56
    Country: Number of subjects enrolled
    Puerto Rico: 65
    Worldwide total number of subjects
    641
    EEA total number of subjects
    216
    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)
    436
    From 65 to 84 years
    203
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    No text entered.

    Pre-assignment
    Screening details
    No text entered.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    LY2605541
    Arm description
    Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 was given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    LY2605541
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG).

    Arm title
    Human Insulin NPH
    Arm description
    Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin isophane suspension (NPH) was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.
    Arm type
    Active comparator

    Investigational medicinal product name
    Human Insulin NPH
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG.

    Number of subjects in period 1
    LY2605541 Human Insulin NPH
    Started
    428
    213
    Received at Least One Dose of Study Drug
    427
    212
    Completed
    393
    202
    Not completed
    35
    11
         Physician decision
    3
    1
         Adverse event, serious fatal
    4
    -
         Adverse event, non-fatal
    3
    2
         Consent withdrawn by subject
    13
    2
         Protocol Required Discontinuation
    7
    1
         Sponsor Decision
    -
    3
         Lost to follow-up
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2605541
    Reporting group description
    Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 was given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.

    Reporting group title
    Human Insulin NPH
    Reporting group description
    Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin isophane suspension (NPH) was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.

    Reporting group values
    LY2605541 Human Insulin NPH Total
    Number of subjects
    428 213 641
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.86 ± 9.76 59.79 ± 10.10 -
    Gender categorical
    Units: Subjects
        Female
    209 107 316
        Male
    219 106 325
    Ethnicity (NIH/OMB)
    Participants who were not located in the United States were reported in the "Unknown or Not Reported" category for ethnicity.
    Units: Subjects
        Hispanic or Latino
    148 73 221
        Not Hispanic or Latino
    195 105 300
        Unknown or Not Reported
    85 35 120
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1 0 1
        Asian
    53 25 78
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    27 9 36
        White
    345 178 523
        More than one race
    0 1 1
        Unknown or Not Reported
    2 0 2
    Body Mass Index (BMI)
    Body mass index is an estimate of body fat based on body weight divided by height squared.
    Units: kilograms/square meters (kg/m^2)
        arithmetic mean (standard deviation)
    30.80 ± 5.57 31.04 ± 5.03 -
    Duration of Diabetes
    Units: years
        arithmetic mean (standard deviation)
    10.87 ± 6.46 11.40 ± 7.01 -

    End points

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    End points reporting groups
    Reporting group title
    LY2605541
    Reporting group description
    Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose was 10 units and was adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 was given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks.

    Reporting group title
    Human Insulin NPH
    Reporting group description
    Administered by SC injection once daily at bedtime. Initial dose was 10 units and was adjusted weekly based on FBG. Human insulin isophane suspension (NPH) was used alone or in combination with up to 3 pre-study OAM(s) whose use was not excluded in combination with insulin. Treatment may have lasted up to 26 weeks. Some participants who were unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may have been asked to add a second injection prior to the morning meal.

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

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    End point title
    Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
    End point description
    Glycosylated hemoglobin A1 (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 by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.
    End point type
    Primary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    420
    212
    Units: percentage of HbA1c
        least squares mean (standard error)
    -1.73 ± 0.04
    -1.36 ± 0.06
    Statistical analysis title
    HbA1c statistical analysis
    Comparison groups
    LY2605541 v Human Insulin NPH
    Number of subjects included in analysis
    632
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Least Square Mean Difference
    Point estimate
    -0.37
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    -0.23

    Secondary: 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events

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    End point title
    30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
    End point description
    Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline event rate of the corresponding hypoglycemia as covariates, log (exposure/30 days) as the offset in the model. 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 received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    425
    212
    Units: episodes per participant per 30 days
    arithmetic mean (standard error)
        Total
    1.46 ± 0.09
    1.73 ± 0.13
        Nocturnal
    0.31 ± 0.04
    0.61 ± 0.07
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HbA1c ≤6.5% and <7.0%

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    End point title
    Percentage of Participants With HbA1c ≤6.5% and <7.0%
    End point description
    Percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    420
    212
    Units: Percentage of Participants
    number (not applicable)
        HbA1c ≤6.5%
    43.4
    24.1
        HbA1c <7.0%
    66.3
    44.7
    No statistical analyses for this end point

    Secondary: Fasting Serum Glucose (FSG) (by Laboratory)

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    End point title
    Fasting Serum Glucose (FSG) (by Laboratory)
    End point description
    LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FSG.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    422
    212
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    112.61 ± 1.56
    118.60 ± 2.20
    No statistical analyses for this end point

    Secondary: Fasting Blood Glucose (FBG) (by Self Monitoring)

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    End point title
    Fasting Blood Glucose (FBG) (by Self Monitoring)
    End point description
    LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    423
    209
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    111.37 ± 1.15
    109.75 ± 1.60
    No statistical analyses for this end point

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

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    End point title
    6-Point Self-Monitored Blood Glucose (SMBG)
    End point description
    6-point SMBG profiles were obtained on 3 nonconsecutive days in the week prior to Weeks 0, 4, 8, 12, 16, and 26. The SMBG measurements were performed while fasting (prior to the morning meal [breakfast]), prior to the midday meal (lunch), prior to the evening meal (dinner), at bedtime, at approximately 0300 hours, and the next day fasting (prior to the morning meal). LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), ], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline SMBG at the same time point of the response variable as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable blood glucose data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    400
    204
    Units: mg/dL
    least squares mean (standard error)
        Pre-morning meal (n=400, 203)
    111.22 ± 1.15
    109.56 ± 1.61
        Pre-midday meal (n=396, 202)
    123.78 ± 1.75
    133.77 ± 2.44
        Pre-evening meal (n=392, 204)
    130.90 ± 1.75
    146.99 ± 2.41
        Bedtime (n=383, 199)
    144.14 ± 1.96
    159.17 ± 2.72
        0300 hours (n=372, 192)
    116.35 ± 1.55
    117.66 ± 2.15
        Pre-morning meal the next day (n=400, 204)
    110.42 ± 1.18
    109.03 ± 1.65
    No statistical analyses for this end point

    Secondary: Change From Baseline to 26 Weeks in Body Weight

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    End point title
    Change From Baseline to 26 Weeks in Body Weight
    End point description
    LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline weight as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable body weight data.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    419
    212
    Units: kilograms (kg)
        least squares mean (standard error)
    2.02 ± 0.16
    2.34 ± 0.22
    No statistical analyses for this end point

    Secondary: HbA1c

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    End point title
    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 by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    420
    212
    Units: percentage of HbA1c
        least squares mean (standard error)
    6.76 ± 0.04
    7.12 ± 0.06
    No statistical analyses for this end point

    Secondary: Insulin Dose Per Kilogram (kg) of Body Weight

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    End point title
    Insulin Dose Per Kilogram (kg) of Body Weight
    End point description
    LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, and treatment-by-visit interaction as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable insulin dose and body weight data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    423
    211
    Units: units per kilogram
        least squares mean (standard error)
    0.40 ± 0.01
    0.35 ± 0.02
    No statistical analyses for this end point

    Secondary: Time to Steady-State (Stable Maximum Dose)

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    End point title
    Time to Steady-State (Stable Maximum Dose)
    End point description
    Steady-state was defined as the first local maximum dose (peak dose value) of LY2605541 or human insulin NPH within the window of -2 to +2 weeks. The median time to steady-state of basal insulin dose estimated from Kaplan-Meier analysis was summarized by treatment. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable steady state data.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    427
    212
    Units: weeks
        median (confidence interval 95%)
    7.14 (6.57 to 8.14)
    5.86 (5.14 to 6.29)
    No statistical analyses for this end point

    Secondary: Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index

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    End point title
    Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
    End point description
    The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and extreme problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United States (US) population-based algorithm. The EQ-5D-3L US based index scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. LS means were calculated from ANCOVA using treatment, stratification factor (country, baseline sulfonylurea sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]) and baseline value of EQ-5D-3Las covariates.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable EQ-5D-3L data. Missing endpoints were imputed with the last observation carried forward (LOCF) method.
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    397
    204
    Units: units on a scale
        least squares mean (standard error)
    0.02 ± 0.01
    0.01 ± 0.01
    No statistical analyses for this end point

    Secondary: Insulin Treatment Satisfaction Questionnaire (ITSQ) Score

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    End point title
    Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
    End point description
    ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, higher scores indicate better treatment satisfaction. LS means were calculated using analysis of variance (ANOVA) adjusting for treatment and stratification factors (country, baseline sulfonylureas/meglitinide use [Yes/No], baseline HbA1c [≤8.5% or >8.5%]). Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable ITSQ data. Missing endpoints were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    419
    211
    Units: units on a scale
        least squares mean (standard error)
    85.04 ± 0.63
    83.84 ± 0.89
    No statistical analyses for this end point

    Secondary: Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores

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    End point title
    Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
    End point description
    Adult LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (always). Items are categorized in 2 domains: Behavior (or avoidance) with 15 items and Worry (or affect) with 18 items. Sum all the items to obtain a total score (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, stratification factor (country, baseline sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c (≤8.5% or >8.5%), and baseline value of LBSS. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable LBSS data. Missing endpoints were imputed with the LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    400
    206
    Units: units on a scale
        least squares mean (standard error)
    0.53 ± 0.72
    2.05 ± 1.01
    No statistical analyses for this end point

    Secondary: Change From Baseline to 26 Weeks in Lipid Profile

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    End point title
    Change From Baseline to 26 Weeks in Lipid Profile
    End point description
    Lipid profile includes total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. LS means for post-baseline measures were calculated using MMRM with the fixed effects of stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. LS means for End Of Study measures were calculated using ANCOVA adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL]except for the LDL-C outcome variable), treatment, and baseline value of corresponding lipid outcome variable.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks; Baseline, End Of Study Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable lipid data. Missing endpoints for End Of Study measures were imputed with the LOCF method
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    420
    212
    Units: mg/dL
    least squares mean (standard error)
        Total cholesterol, 26 Weeks
    2.08 ± 1.42
    2.86 ± 2.00
        Total cholesterol, End Of Study
    -0.12 ± 1.36
    2.94 ± 1.92
        HDL, 26 Weeks
    -0.24 ± 0.31
    0.41 ± 0.44
        HDL, End Of Study
    0.53 ± 0.31
    0.40 ± 0.44
        LDL, 26 Weeks
    3.01 ± 1.24
    5.90 ± 1.74
        LDL, End Of Study
    2.54 ± 1.20
    3.89 ± 1.69
        Triglycerides, 26 Weeks
    -1.49 ± 4.62
    -15.38 ± 6.49
        Triglycerides, End Of Study
    -20.34 ± 4.79
    -0.45 ± 6.74
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Insulin Antibodies

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    End point title
    Percentage of Participants With Insulin Antibodies
    End point description
    The percentage of participants with a positive treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR was defined as change from baseline to postbaseline in the anti-LY2605541 antibody level either (1) from undetectable to detectable or (2) from detectable to the value with at least 130% relative increase from baseline. Percentage of participants was calculated by dividing the number of participants with TEAR anytime during the treatment period by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable anti-drug (LY2605541) antibodies (ADA) data.
    End point type
    Secondary
    End point timeframe
    Baseline to 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    422
    212
    Units: percentage of participants
        number (not applicable)
    19.7
    45.8
    No statistical analyses for this end point

    Secondary: Intra-Participant Variability in FBG by Standard Deviation

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    End point title
    Intra-Participant Variability in FBG by Standard Deviation
    End point description
    Glucose variability was assessed by between-day variability as measured by the standard deviation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    421
    208
    Units: mg/dL
        least squares mean (standard error)
    14.44 ± 0.50
    19.07 ± 0.70
    No statistical analyses for this end point

    Secondary: Intra-Participant Variability in FBG by the Coefficient of Variation

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    End point title
    Intra-Participant Variability in FBG by the Coefficient of Variation
    End point description
    Glucose variability was assessed by between-day variability as measured by the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    421
    208
    Units: mg/dL
        least squares mean (standard error)
    12.87 ± 0.40
    17.05 ± 0.56
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Total and Nocturnal Hypoglycemic Events

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    End point title
    Percentage of Participants With Total and Nocturnal Hypoglycemic Events
    End point description
    Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants with at least one hypoglycemia divided by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    425
    212
    Units: percentage of participants
    number (not applicable)
        Total
    76.7
    83.5
        Nocturnal
    41.6
    67.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia

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    End point title
    Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
    End point description
    Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants reaching target HbA1c without nocturnal hypoglycemia divided by the total number of participants analyzed, multiplied by 100. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data and hypoglycemia data.
    End point type
    Secondary
    End point timeframe
    26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    420
    212
    Units: percentage of participants
        number (not applicable)
    39.1
    12.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Injection Site Reactions

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    End point title
    Percentage of Participants With Injection Site Reactions
    End point description
    The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    427
    212
    Units: percentage of participants
        number (not applicable)
    0.7
    1.4
    No statistical analyses for this end point

    Secondary: Rate of Severe Hypoglycemic Events

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    End point title
    Rate of Severe Hypoglycemic Events
    End point description
    Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The hypoglycemia rate per 100 years during a defined period was calculated by the number of hypoglycemia events within the period divided by the number of days participant at risk within the period*36525 days. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    425
    212
    Units: events per 100 participant years
        arithmetic mean (standard error)
    1.00 ± 0.71
    0.00 ± 0.00
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Severe Hypoglycemic Events

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    End point title
    Percentage of Participants With Severe Hypoglycemic Events
    End point description
    Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The percentage of participants with at least one severe hypoglycemia is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data.
    End point type
    Secondary
    End point timeframe
    Baseline through 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    425
    212
    Units: percentage of participants
        number (not applicable)
    0.5
    0.0
    No statistical analyses for this end point

    Secondary: Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores

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    End point title
    Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
    End point description
    The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Analysis Population Description: Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable EuroQol-5D-3L data.
    End point type
    Secondary
    End point timeframe
    Baseline, 26 Weeks
    End point values
    LY2605541 Human Insulin NPH
    Number of subjects analysed
    399
    206
    Units: units on a scale
        least squares mean (standard error)
    2.52 ± 0.68
    1.41 ± 0.95
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Analysis Period 2 (AP2)
    Adverse event reporting additional description
    I2R-MC-BIAK
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    LY2605541
    Reporting group description
    -

    Reporting group title
    Human Insulin NPH
    Reporting group description
    -

    Serious adverse events
    LY2605541 Human Insulin NPH
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 427 (6.56%)
    9 / 212 (4.25%)
         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)
    glioblastoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant peritoneal neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    non-hodgkin's lymphoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ovarian neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (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
    uterovaginal prolapse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrial flutter
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    atrioventricular block
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    coronary artery insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    carotid artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus ureteric
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    hepatic cirrhosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    psoriasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    intervertebral disc disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    abdominal wall abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (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 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hepatitis c
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    meningitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    LY2605541 Human Insulin NPH
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    228 / 427 (53.40%)
    111 / 212 (52.36%)
    Vascular disorders
    flushing
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    1 / 212 (0.47%)
         occurrences all number
    6
    1
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    thrombophlebitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    venous insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    anorectal operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    cataract operation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    2
    colon polypectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    coronary artery bypass
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    dental implantation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    endarterectomy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    epidural anaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    medical device removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    nerve block
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    tooth extraction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    ureteral stent removal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    pancreatic neoplasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    allergy to arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    food allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    multiple allergies
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    2
    seasonal allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    chest discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    2 / 212 (0.94%)
         occurrences all number
    2
    2
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    5 / 212 (2.36%)
         occurrences all number
    1
    5
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    injection site hypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    injection site nodule
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    injection site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    injection site rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 427 (2.58%)
    3 / 212 (1.42%)
         occurrences all number
    14
    3
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    spinal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    vessel puncture site bruise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    vessel puncture site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    1 / 212 (0.47%)
         occurrences all number
    3
    1
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    nervousness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    psychogenic seizure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    sleep disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    cervical dysplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    dysmenorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    animal bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    animal scratch
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    ankle fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    arthropod bite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    arthropod sting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    back injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    bone fissure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    1 / 212 (0.47%)
         occurrences all number
    4
    1
    epicondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    eye contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    2 / 212 (0.94%)
         occurrences all number
    0
    2
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    laceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 427 (1.17%)
    0 / 212 (0.00%)
         occurrences all number
    5
    0
    limb crushing injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    limb injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    skin injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    spinal compression fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    stab wound
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    stress fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    thermal burn
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    tooth fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    upper limb fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    2 / 212 (0.94%)
         occurrences all number
    8
    2
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    2 / 212 (0.94%)
         occurrences all number
    6
    2
    biopsy thyroid gland
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    blood creatinine increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    blood pressure increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    blood triglycerides increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    blood urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    electrocardiogram t wave inversion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    protein urine present
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    transaminases increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    14 / 427 (3.28%)
    5 / 212 (2.36%)
         occurrences all number
    15
    5
    white blood cell count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    white blood cell count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    bundle branch block right
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    coronary artery disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    2 / 212 (0.94%)
         occurrences all number
    0
    2
    coronary artery stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    myocardial ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    ventricular extrasystoles
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    Congenital, familial and genetic disorders
    type iv hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    type v hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    0 / 212 (0.00%)
         occurrences all number
    4
    0
    hypochromic anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    leukocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    monocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    thrombocytopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 427 (2.58%)
    11 / 212 (5.19%)
         occurrences all number
    12
    11
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 427 (1.87%)
    4 / 212 (1.89%)
         occurrences all number
    8
    5
    productive cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    respiratory tract congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    2 / 212 (0.94%)
         occurrences all number
    2
    2
    rhinitis allergic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    balance disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    convulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    dementia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    diabetic neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    7 / 212 (3.30%)
         occurrences all number
    4
    8
    dysgeusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    23 / 427 (5.39%)
    9 / 212 (4.25%)
         occurrences all number
    30
    17
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    0 / 212 (0.00%)
         occurrences all number
    6
    0
    neuralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    polyneuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    presyncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    sensory loss
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    sinus headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    speech disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    tension headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    transient global amnesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    viith nerve paralysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    Eye disorders
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    diabetic retinal oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    eye allergy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    eye pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    eye pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    glaucoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    panophthalmitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    retinal artery occlusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    retinopathy hypertensive
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    scleritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    vision blurred
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    deafness unilateral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    ear pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    meniere's disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    abdominal distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    0 / 212 (0.00%)
         occurrences all number
    4
    0
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    3
    abdominal pain lower
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    3
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    3 / 212 (1.42%)
         occurrences all number
    2
    3
    anal pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    colitis ulcerative
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    dental caries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    13 / 427 (3.04%)
    6 / 212 (2.83%)
         occurrences all number
    16
    9
    dry mouth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    5 / 212 (2.36%)
         occurrences all number
    2
    8
    epigastric discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    gastric ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    gastritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    gastrointestinal disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    2
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    gingival inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    impaired gastric emptying
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    irritable bowel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    mouth ulceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    3 / 212 (1.42%)
         occurrences all number
    6
    5
    pancreatic steatosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    swollen tongue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    toothache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    0 / 212 (0.00%)
         occurrences all number
    6
    0
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 427 (1.17%)
    3 / 212 (1.42%)
         occurrences all number
    5
    3
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    bladder spasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    diabetic nephropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    hydronephrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    pollakiuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    renal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    renal failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    urinary retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    blister
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    dermal cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    dermatitis contact
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    dermatosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    ecchymosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    heat rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    lipohypertrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    3 / 212 (1.42%)
         occurrences all number
    1
    4
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    3 / 212 (1.42%)
         occurrences all number
    4
    3
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    ankylosing spondylitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    6 / 212 (2.83%)
         occurrences all number
    3
    7
    arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    16 / 427 (3.75%)
    8 / 212 (3.77%)
         occurrences all number
    17
    10
    bursitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    flank pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    joint effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    1 / 212 (0.47%)
         occurrences all number
    3
    1
    muscle swelling
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    0 / 212 (0.00%)
         occurrences all number
    6
    0
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 427 (0.94%)
    2 / 212 (0.94%)
         occurrences all number
    4
    3
    myositis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    2
    neck pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    2 / 212 (0.94%)
         occurrences all number
    2
    2
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    2 / 212 (0.94%)
         occurrences all number
    2
    2
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    11 / 427 (2.58%)
    3 / 212 (1.42%)
         occurrences all number
    11
    6
    synovial cyst
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    tendonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    hypogonadism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    hypothyroidism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    abnormal loss of weight
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    abnormal weight gain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    gout
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    hyperglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 427 (1.17%)
    0 / 212 (0.00%)
         occurrences all number
    5
    0
    hyperuricaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    hypokalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    obesity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    overweight
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    Infections and infestations
    bone abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 427 (1.87%)
    4 / 212 (1.89%)
         occurrences all number
    8
    4
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    4
    0
    conjunctivitis infective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    cystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    1 / 212 (0.47%)
         occurrences all number
    4
    1
    dengue fever
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    diverticulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    ear infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    eye infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    0 / 212 (0.00%)
         occurrences all number
    2
    0
    fungal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    furuncle
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    5
    0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    1 / 212 (0.47%)
         occurrences all number
    4
    1
    gastroenteritis viral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    2 / 212 (0.94%)
         occurrences all number
    1
    2
    helicobacter infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    herpes simplex
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    3 / 212 (1.42%)
         occurrences all number
    2
    3
    hordeolum
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 427 (1.64%)
    7 / 212 (3.30%)
         occurrences all number
    8
    8
    laryngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    lower respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    nail infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    29 / 427 (6.79%)
    23 / 212 (10.85%)
         occurrences all number
    39
    34
    oral herpes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    2
    otitis externa
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    1 / 212 (0.47%)
         occurrences all number
    1
    1
    paronychia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    pulpitis dental
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    2 / 212 (0.94%)
         occurrences all number
    0
    2
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 427 (0.70%)
    0 / 212 (0.00%)
         occurrences all number
    3
    0
    rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    scarlet fever
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 427 (0.00%)
    1 / 212 (0.47%)
         occurrences all number
    0
    1
    sinusitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 427 (1.41%)
    5 / 212 (2.36%)
         occurrences all number
    7
    7
    skin infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    soft tissue infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    testicular abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    tooth abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    2 / 212 (0.94%)
         occurrences all number
    2
    3
    tooth infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 427 (1.17%)
    0 / 212 (0.00%)
         occurrences all number
    5
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 427 (4.22%)
    5 / 212 (2.36%)
         occurrences all number
    23
    5
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 427 (2.34%)
    4 / 212 (1.89%)
         occurrences all number
    14
    5
    vaginitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    varicella
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 427 (0.47%)
    1 / 212 (0.47%)
         occurrences all number
    2
    1
    wound infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 427 (0.23%)
    0 / 212 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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