Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44365   clinical trials with a EudraCT protocol, of which   7389   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

    Summary
    EudraCT number
    		 2011-003142-41
    Trial protocol
    		 IT   LT   FI   PL   BE   CZ   ES   EE   GR   DE   GB   SE   AT   DK   LV   NO   NL   HU   IE   SK   BG  
    Global end of trial date
    29 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2018
    First version publication date
    15 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    20110142
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01631214
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    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
    29 Jun 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the effect of romosozumab treatment for 12 months followed by alendronate treatment compared with alendronate treatment alone on the subject incidence of: - clinical fracture (nonvertebral fracture and clinical vertebral fracture); and - new vertebral fracture in postmenopausal women with osteoporosis.
    Protection of trial subjects
    This study was conducted in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and applicable Food and Drug Administration (FDA) or local regulations/guidelines. The study protocol, subject information, and informed consent form (ICF) were reviewed and approved by the independent ethics committee (IEC) or institutional review board (IRB) for each study center. Before any study procedures were performed or any investigational products were administered, the investigator obtained written informed consent from each subject after adequate explanation of the aims, methods, anticipated benefits, and potential hazards of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 704
    Country: Number of subjects enrolled
    Czech Republic: 282
    Country: Number of subjects enrolled
    Russian Federation: 157
    Country: Number of subjects enrolled
    Hungary: 142
    Country: Number of subjects enrolled
    Bulgaria: 112
    Country: Number of subjects enrolled
    Estonia: 51
    Country: Number of subjects enrolled
    Lithuania: 50
    Country: Number of subjects enrolled
    Latvia: 43
    Country: Number of subjects enrolled
    Austria: 37
    Country: Number of subjects enrolled
    Romania: 23
    Country: Number of subjects enrolled
    Slovakia: 16
    Country: Number of subjects enrolled
    Turkey: 9
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Colombia: 634
    Country: Number of subjects enrolled
    Brazil: 295
    Country: Number of subjects enrolled
    Peru: 119
    Country: Number of subjects enrolled
    Mexico: 117
    Country: Number of subjects enrolled
    Argentina: 108
    Country: Number of subjects enrolled
    Guatemala: 75
    Country: Number of subjects enrolled
    Dominican Republic: 29
    Country: Number of subjects enrolled
    Chile: 24
    Country: Number of subjects enrolled
    Italy: 76
    Country: Number of subjects enrolled
    United Kingdom: 76
    Country: Number of subjects enrolled
    Denmark: 73
    Country: Number of subjects enrolled
    France: 41
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Spain: 38
    Country: Number of subjects enrolled
    Norway: 35
    Country: Number of subjects enrolled
    Greece: 33
    Country: Number of subjects enrolled
    Belgium: 29
    Country: Number of subjects enrolled
    Sweden: 28
    Country: Number of subjects enrolled
    Netherlands: 25
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Finland: 13
    Country: Number of subjects enrolled
    New Zealand: 9
    Country: Number of subjects enrolled
    Hong Kong: 249
    Country: Number of subjects enrolled
    South Africa: 154
    Country: Number of subjects enrolled
    Korea, Republic of: 20
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    United States: 57
    Country: Number of subjects enrolled
    Canada: 40
    Worldwide total number of subjects
    4093
    EEA total number of subjects
    1965
    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)
    479
    From 65 to 84 years
    3286
    85 years and over
    328

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 270 centers in 41 countries globally from 04 May 2012 to 29 June 2017.

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:1 ratio to receive romosozumab or alendronate for 12 months. Randomization was stratified by age (< 75 vs. ≥ 75 years). After completion of the double-blind trial period, all participants received open-label alendronate until the end of the trial, with blinding to the initial treatment assignment maintained.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Alendronate/Alendronate
    Arm description
    		 Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Alendronate
    Investigational medicinal product code
    Other name
    Fosamax®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alendronate 70-mg tablet taken once a week

    Investigational medicinal product name
    Placebo to Romosozumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered by subcutaneous injection once a month during the double-blind treatment phase.

    Arm title
    		 Romosozumab/Alendronate
    Arm description
    		 Participants received 210 romosozumab mg subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to Alendronate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet taken once a week during the double-blind treatment phase.

    Investigational medicinal product name
    Alendronate
    Investigational medicinal product code
    Other name
    Fosamax®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Alendronate 70 mg tablet taken once a week during the open-label treatment phase.

    Investigational medicinal product name
    Romosozumab
    Investigational medicinal product code
    AMG 785
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.

    Number of subjects in period 1
    		Alendronate/Alendronate Romosozumab/Alendronate
    Started
    2047
    2046
    Received Double-blind Treatment
    2040
    2038
    Completed Double-blind Period
    1823
    1831
    Completed
    1503
    1523
    Not completed
    544
    523
         Consent withdrawn by subject
    276
    290
         Adverse event, non-fatal
    45
    45
         Administrative decision
    1
    -
         Death
    113
    106
         Other
    22
    19
         Protocol deviation
    4
    3
         Lost to follow-up
    54
    40
         Ineligibility determined
    5
    2
         Noncompliance
    16
    15
         Requirement for alternative therapy
    8
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Alendronate/Alendronate
    Reporting group description
    		 Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.

    Reporting group title
    Romosozumab/Alendronate
    Reporting group description
    		 Participants received 210 romosozumab mg subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

    Reporting group values
    		 Alendronate/Alendronate Romosozumab/Alendronate Total
    Number of subjects
    		 2047 2046 4093
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 240 239 479
        From 65-84 years
    		 1642 1644 3286
        85 years and over
    		 165 163 328
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 74.2 ( 7.5 ) 74.4 ( 7.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 2047 2046 4093
        Male
    		 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 7 5 12
        Asian
    		 149 137 286
        Black or African American
    		 23 19 42
        Native Hawaiian or Other Pacific Islander
    		 2 0 2
        White
    		 1415 1447 2862
        Multiple
    		 4 2 6
        Other
    		 446 436 882
        Missing
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 662 631 1293
        Not Hispanic or Latino
    		 1385 1415 2800
    Age Strata per Randomization
    Units: Subjects
        < 75 years
    		 976 973 1949
        ≥ 75 years
    		 1071 1073 2144
    Severe Vertebral Fracture
    A subject had a prevalent vertebral fracture if any vertebra from T4 to L4 had a grade of 3 at baseline based on an assessment of spinal radiographs using Genant Semiquantitative Scoring Method. Otherwise, a subject was considered absence of severe vertebral fracture at baseline. vertebral fracture at baseline.
    Units: Subjects
        Presence
    		 1321 1369 2690
        Absence
    		 726 677 1403
    Total Hip Bone Mineral Density (BMD) T-score
    BMD was measured using dual-energy x-ray absorptiometry (DXA). The T-score is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex. Lower scores (more negative) mean lower bone density: A T-score of -2.5 or lower qualifies as osteoporosis and a T-score of -1.0 to -2.5 signifies osteopenia, meaning below-normal bone density without full osteoporosis.
    Units: Subjects
        ≤ -2.5
    		 1384 1356 2740
        > -2.5
    		 662 690 1352
        Missing
    		 1 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Alendronate/Alendronate
    Reporting group description
    		 Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.

    Reporting group title
    Romosozumab/Alendronate
    Reporting group description
    		 Participants received 210 romosozumab mg subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

    Primary: Percentage of Participants with New Vertebral Fractures Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with New Vertebral Fractures Through Month 24
    End point description
    New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method based on assessment of x-rays according to the following scale: • Grade 0 (Normal) = no fracture; • Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); • Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; • Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. The analysis was conducted in randomized participants with a baseline and ≥ 1 post-baseline evaluation of vertebral fracture at or before 24 months and includes participants who had vertebrae with missing Genant semiquantitative scores at baseline and whose first post-baseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.
    End point type
    Primary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1834
    1825
    Units: percentage of participants
        number (not applicable)
    8.0
    4.1
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [1] - The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 P-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.
    [2] - Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline. The standard error (SE) represents the standard error of log(odds ratio).
    Statistical analysis title
    		 Risk Ratio
    Statistical analysis description
    The risk ratio (ratio of proportions, Romosozumab over Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T score at the total hip (≤ -2.5, > -2.5). SE represents the standard error of log(risk ratio).
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Absolute Risk Reduction
    Statistical analysis description
    The absolute risk reduction (difference in proportions, alendronate – romosozumab) based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Absolute risk reduction
    Point estimate
    4.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 5.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.78

    Primary: Percentage of Participants with a Clinical Fracture at the Primary Analysis

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Clinical Fracture at the Primary Analysis
    End point description
    Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants. Missing values for clinical vertebral fractures were imputed using last observation carried forward.
    End point type
    Primary
    End point timeframe
    The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    13.0
    9.7
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.09
    Notes
    [3] - The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 P-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.
    [4] - Based on a Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Nonvertebral Fracture at the Primary Analysis

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Nonvertebral Fracture at the Primary Analysis
    End point description
    A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    10.6
    8.7
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.04 [6]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [5] - If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided). The adjusted 2-sided p-value is reported.
    [6] - Based on a Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with any Fracture at the Primary Analysis

    		 Close Top of page
    End point title
    		 Percentage of Participants with any Fracture at the Primary Analysis
    End point description
    All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    19.1
    13.0
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 < 0.001 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 0.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Notes
    [7] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [8] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a New or Worsening Vertebral Fracture Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with a New or Worsening Vertebral Fracture Through Month 24
    End point description
    A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. The analysis was conducted in randomized participants with a baseline and ≥ 1 post-baseline evaluation of vertebral fracture at or before 24 months and includes participants who had vertebrae with missing Genant semiquantitative scores at baseline and whose first post-baseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1834
    1825
    Units: percentage of participants
        number (not applicable)
    9.2
    4.8
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 < 0.001 [10]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Notes
    [9] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [10] - Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline; p-value based on score test. SE represents the standard error of log(odds ratio).
    Statistical analysis title
    		 Absolute Risk Reduction
    Statistical analysis description
    The absolute risk reduction (difference in proportions, Alendronate – Romosozumab) based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Absolute Risk Reduction
    Point estimate
    4.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 6.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.84
    Statistical analysis title
    		 Risk Ratio
    Statistical analysis description
    The risk ratio (ratio of proportions, Romosozumab over Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T score at the total hip (≤ -2.5, > -2.5). SE represents the standard error of log(risk ratio).
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.13

    Secondary: Percentage of Participants with a Major Nonvertebral Fracture at the Primary Analysis

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Major Nonvertebral Fracture at the Primary Analysis
    End point description
    A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    9.6
    7.1
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.004 [12]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [11] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [12] - Based on a Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Hip Fracture at the Primary Analysis

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Hip Fracture at the Primary Analysis
    End point description
    Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    3.2
    2.0
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.015 [14]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [13] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [14] - Based on a Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with Multiple New or Worsening Vertebral Fractures Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with Multiple New or Worsening Vertebral Fractures Through Month 24
    End point description
    A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. The analysis was conducted in randomized participants with a baseline and ≥ 1 post-baseline evaluation of vertebral fracture at or before 24 months and includes participants who had vertebrae with missing Genant semiquantitative scores at baseline and whose first post-baseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1834
    1825
    Units: percentage of participants
        number (not applicable)
    2.5
    1.3
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.008 [16]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Notes
    [15] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [16] - Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline. SE represents the standard error of log(odds ratio).
    Statistical analysis title
    		 Risk Ratio
    Statistical analysis description
    The risk ratio (ratio of proportions, Romosozumab over Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T score at the total hip (≤ -2.5, > -2.5). SE represents the standard error of log(risk ratio).
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Absolute Risk Reduction
    Statistical analysis description
    The absolute risk reduction (difference in proportions, alendronate – romosozumab) based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3659
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Absolute risk reduction
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 2.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.45

    Secondary: Percentage of Participants with a Clinical Fracture Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Clinical Fracture Through Month 24
    End point description
    Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants. Missing values for clinical vertebral fractures were imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    9.6
    7.1
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.005 [18]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [17] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [18] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Nonvertebral Fracture Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Nonvertebral Fracture Through Month 24
    End point description
    A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    7.8
    6.3
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.074 [20]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.12
    Notes
    [19] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [20] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Hip Fracture Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Hip Fracture Through Month 24
    End point description
    Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    2.1
    1.5
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.17 [22]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.24
    Notes
    [21] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [22] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Clinical Vertebral Fracture Through Month 24

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Clinical Vertebral Fracture Through Month 24
    End point description
    A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic. The analysis was conducted in all randomized participants. Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    2.1
    0.9
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 < 0.001 [24]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 0.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Notes
    [23] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [24] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log(hazards ratio).

    Secondary: Percentage of Participants with a Clinical Fracture Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Clinical Fracture Through Month 12
    End point description
    Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants. Missing values for clinical vertebral fractures were imputed using last observation carried forward.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    5.4
    3.9
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    P-value
    		 = 0.027 [26]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [25] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [26] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with New Vertebral Fractures Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with New Vertebral Fractures Through Month 12
    End point description
    New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method based on assessment of x-rays according to the following scale: • Grade 0 (Normal) = no fracture; • Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior); • Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height; • Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height. The analysis was conducted in randomized participants with a baseline and ≥ 1 post-baseline evaluation of vertebral fracture at or before 12 months and includes participants who had vertebrae with missing Genant semiquantitative scores at baseline and whose first post-baseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1703
    1696
    Units: percentage of participants
        number (not applicable)
    5.0
    3.2
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3399
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    P-value
    		 = 0.008 [28]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Notes
    [27] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [28] - Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline. SE represents the standard error of log (odds ratio).
    Statistical analysis title
    		 Risk Ratio
    Statistical analysis description
    The risk ratio (ratio of proportions, Romosozumab over Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T score at the total hip (≤ -2.5, > -2.5). SE represents the standard error of log (risk ratio).
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3399
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Statistical analysis title
    		 Absolute Risk Reduction
    Statistical analysis description
    The absolute risk reduction (difference in proportions, alendronate – romosozumab) based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3399
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Absolute risk reduction
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 3.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.68

    Secondary: Percentage of Participants with Any Fracture Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with Any Fracture Through Month 12
    End point description
    All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    9.2
    6.5
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    P-value
    		 = 0.002 [30]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [29] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [30] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Nonvertebral Fracture Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Nonvertebral Fracture Through Month 12
    End point description
    A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    4.6
    3.4
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [31]
    P-value
    		 = 0.057 [32]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Notes
    [31] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [32] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Hip Fracture Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Hip Fracture Through Month 12
    End point description
    Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    1.1
    0.7
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [33]
    P-value
    		 = 0.19 [34]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Notes
    [33] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [34] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Major Osteoporotic Fracture Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Major Osteoporotic Fracture Through Month 12
    End point description
    Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded. The analysis was conducted in all randomized participants.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of particiapnts
        number (not applicable)
    4.2
    3.0
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    P-value
    		 = 0.053 [36]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Notes
    [35] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [36] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percentage of Participants with a Clinical Vertebral Fracture Through Month 12

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Clinical Vertebral Fracture Through Month 12
    End point description
    A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic. The analysis was conducted in all randomized participants. Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    2047
    2046
    Units: percentage of participants
        number (not applicable)
    0.9
    0.5
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    4093
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [37]
    P-value
    		 = 0.14 [38]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Notes
    [37] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [38] - Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline. SE represents the standard error of log (hazard ratio).

    Secondary: Percent Change from Baseline in Bone Mineral Density at the Lumbar Spine at Month 24

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline and month 24
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1577
    1571
    Units: percent change
        least squares mean (standard error)
    7.2 ( 0.2 )
    15.3 ( 0.2 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3148
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [39]
    P-value
    		 < 0.001 [40]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.58
         upper limit
    		 8.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [39] - If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.
    [40] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density of the Total Hip at Month 24

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density of the Total Hip at Month 24
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline and month 24
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1627
    1622
    Units: percent change
        least squares mean (standard error)
    3.5 ( 0.1 )
    7.2 ( 0.1 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [41]
    P-value
    		 < 0.001 [42]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.42
         upper limit
    		 4.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [41] - If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.
    [42] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density of the Femoral Neck at Month 24

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density of the Femoral Neck at Month 24
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline and month 24
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1627
    1622
    Units: percent change
        least squares mean (standard error)
    2.3 ( 0.2 )
    6.0 ( 0.2 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [43]
    P-value
    		 < 0.001 [44]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.4
         upper limit
    		 4.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [43] - If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.
    [44] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density at the Lumbar Spine at Month 12

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1718
    1722
    Units: percent change
        least squares mean (standard error)
    5.0 ( 0.1 )
    13.7 ( 0.2 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3440
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [45]
    P-value
    		 < 0.001 [46]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    8.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.31
         upper limit
    		 9.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [45] - If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.
    [46] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density of the Total Hip at Month 12

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density of the Total Hip at Month 12
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1781
    1781
    Units: percent change
        least squares mean (standard error)
    2.8 ( 0.1 )
    6.2 ( 0.1 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3562
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [47]
    P-value
    		 < 0.001 [48]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.03
         upper limit
    		 3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [47] - If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.
    [48] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density of the Femoral Neck at Month 12

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density of the Femoral Neck at Month 12
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1781
    1781
    Units: percent change
        least squares mean (standard error)
    1.7 ( 0.1 )
    4.9 ( 0.1 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3562
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [49]
    P-value
    		 < 0.001 [50]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 3.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [49] - If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.
    [50] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density at the Lumbar Spine at Month 36

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density at the Lumbar Spine at Month 36
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline and month 36
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1597
    1593
    Units: percent change
        least squares mean (standard error)
    7.8 ( 0.2 )
    15.2 ( 0.2 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [51]
    P-value
    		 < 0.001 [52]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    7.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.84
         upper limit
    		 7.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [51] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [52] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density of the Total Hip at Month 36

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density of the Total Hip at Month 36
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline and month 36
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1653
    1653
    Units: percent change
        least squares mean (standard error)
    3.5 ( 0.1 )
    7.2 ( 0.1 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3306
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [53]
    P-value
    		 < 0.001 [54]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.29
         upper limit
    		 4.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [53] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [54] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.

    Secondary: Percent Change from Baseline in Bone Mineral Density of the Femoral Neck at Month 36

    		 Close Top of page
    End point title
    		 Percent Change from Baseline in Bone Mineral Density of the Femoral Neck at Month 36
    End point description
    Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. The analysis was conducted in all randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.
    End point type
    Secondary
    End point timeframe
    Baseline and month 36
    End point values
    		 Alendronate/Alendronate Romosozumab/Alendronate
    Number of subjects analysed
    1653
    1653
    Units: percent change
        least squares mean (standard error)
    2.4 ( 0.2 )
    6.0 ( 0.2 )
    Statistical analysis title
    		 Primary Analysis
    Comparison groups
    Alendronate/Alendronate v Romosozumab/Alendronate
    Number of subjects included in analysis
    3306
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [55]
    P-value
    		 < 0.001 [56]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.18
         upper limit
    		 3.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [55] - This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).
    [56] - Based on ANCOVA model adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    The 12-month double-blind treatment phase and overall study period which includes AEs up to the end of study for subjects who received an open-label dose and up to 12 months for subjects who did not; overall median duration of follow-up was 36 months.
    Adverse event reporting additional description
    The safety analysis set included all randomized subjects who received ≥ 1 active dose of investigational product in the 12-month double-blind alendronate-controlled study period. Two participants randomized to alendronate received romosozumab in error and are counted in the romosozumab group for safety.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    12-Month Double-blind Period: Alendronate 70 mg QW
    Reporting group description
    		 Participants received 70 mg alendronate once a week (QW) and placebo to romosozumab subcutaneously once a month for 12 months during the double-blind treatment period.

    Reporting group title
    Overall Study: Alendronate / Alendronate
    Reporting group description
    		 Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.

    Reporting group title
    Overall Study: Romosozumab / Alendronate
    Reporting group description
    		 Participants received 210 romosozumab mg subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.

    Reporting group title
    12-Month Double-blind Period: Romosozumab 210 mg QM
    Reporting group description
    		 Participants received 210 mg romosozumab subcutaneously once a month (QM) and placebo to alendronate orally once a week for the first 12 months during the double-blind treatment period.

    Serious adverse events
    		 12-Month Double-blind Period: Alendronate 70 mg QW Overall Study: Alendronate / Alendronate Overall Study: Romosozumab / Alendronate 12-Month Double-blind Period: Romosozumab 210 mg QM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    278 / 2014 (13.80%)
    638 / 2014 (31.68%)
    611 / 2040 (29.95%)
    262 / 2040 (12.84%)
         number of deaths (all causes)
    22
    103
    101
    30
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder squamous cell carcinoma stage unspecified
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Central nervous system neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Cervix carcinoma stage IV
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choroid melanoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal carcinoma stage 0
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epithelioid mesothelioma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hypopharyngeal cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal haemangioma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraocular melanoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Lung adenocarcinoma stage 0
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mediastinum neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Metastases to adrenals
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to pancreas
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma unspecified histology indolent stage I
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of pharynx
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the vulva
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    5 / 2014 (0.25%)
    9 / 2014 (0.45%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Hypovolaemic shock
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labile hypertension
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery occlusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgery
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Umbilical hernia repair
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse event
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 2014 (0.10%)
    21 / 2014 (1.04%)
    14 / 2040 (0.69%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 21
    0 / 14
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    1 / 21
    0 / 14
    0 / 1
    Feeling abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strangulated hernia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 6
    0 / 1
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Limb prosthesis user
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of personal independence in daily activities
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colpocele
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    10 / 2014 (0.50%)
    29 / 2014 (1.44%)
    24 / 2040 (1.18%)
    5 / 2040 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 44
    0 / 33
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Confusional state
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypomania
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Ampulla of Vater stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary cirrhosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary fibrosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    6 / 2014 (0.30%)
    9 / 2014 (0.45%)
    7 / 2040 (0.34%)
    5 / 2040 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoembryonic antigen increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulation time prolonged
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical observation normal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Burns third degree
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 2014 (0.05%)
    7 / 2014 (0.35%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    4 / 2014 (0.20%)
    11 / 2014 (0.55%)
    13 / 2040 (0.64%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 13
    0 / 15
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    12 / 2014 (0.60%)
    31 / 2014 (1.54%)
    15 / 2040 (0.74%)
    5 / 2040 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 31
    0 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Femur fracture
         subjects affected / exposed
    12 / 2014 (0.60%)
    51 / 2014 (2.53%)
    42 / 2040 (2.06%)
    11 / 2040 (0.54%)
         occurrences causally related to treatment / all
    0 / 12
    2 / 51
    3 / 45
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
    1 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured ischium
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft complication
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    7 / 2014 (0.35%)
    16 / 2014 (0.79%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 16
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    8 / 2014 (0.40%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post laminectomy syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    12 / 2014 (0.60%)
    20 / 2014 (0.99%)
    14 / 2040 (0.69%)
    8 / 2040 (0.39%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 20
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Scapula fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    5 / 2014 (0.25%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    5 / 2014 (0.25%)
    8 / 2014 (0.40%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
    1 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    6 / 2014 (0.30%)
    11 / 2014 (0.55%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 2014 (0.10%)
    15 / 2014 (0.74%)
    16 / 2040 (0.78%)
    8 / 2040 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 19
    0 / 17
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 5
    0 / 5
    0 / 3
    Angina pectoris
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    7 / 2040 (0.34%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Angina unstable
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 9
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 2014 (0.20%)
    17 / 2014 (0.84%)
    12 / 2040 (0.59%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 19
    0 / 15
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    5 / 2014 (0.25%)
    25 / 2014 (1.24%)
    18 / 2040 (0.88%)
    5 / 2040 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 31
    0 / 22
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
    0 / 2
    Cardiac failure acute
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 6
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    5 / 2014 (0.25%)
    12 / 2014 (0.60%)
    9 / 2040 (0.44%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 15
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    3 / 2014 (0.15%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Palpitations
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amnesia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid aneurysm rupture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    7 / 2014 (0.35%)
    15 / 2014 (0.74%)
    19 / 2040 (0.93%)
    6 / 2040 (0.29%)
         occurrences causally related to treatment / all
    1 / 8
    1 / 17
    0 / 21
    0 / 6
         deaths causally related to treatment / all
    1 / 2
    1 / 3
    0 / 4
    0 / 1
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    9 / 2040 (0.44%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 11
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Hemiparesis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hypokinesia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Ischaemic neuropathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    3 / 2014 (0.15%)
    10 / 2014 (0.50%)
    10 / 2040 (0.49%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
    0 / 11
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mixed dementia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve root compression
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paresis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic epilepsy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stroke in evolution
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    4 / 2014 (0.20%)
    10 / 2014 (0.50%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    11 / 2040 (0.54%)
    6 / 2040 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    1 / 11
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 2014 (0.15%)
    9 / 2014 (0.45%)
    7 / 2040 (0.34%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular ataxia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    11 / 2040 (0.54%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    2 / 12
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine ophthalmopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Entropion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strabismus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    2 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal polyp
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia incarcerated
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    2 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 6
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Intestinal ulcer
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric arterial occlusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Peritoneal adhesions
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis contact
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral polyp
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercorticoidism
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic goitre
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    9 / 2014 (0.45%)
    17 / 2014 (0.84%)
    11 / 2040 (0.54%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 18
    0 / 11
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extraskeletal ossification
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    5 / 2014 (0.25%)
    11 / 2014 (0.55%)
    19 / 2040 (0.93%)
    6 / 2040 (0.29%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 11
    0 / 19
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in jaw
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 2014 (0.15%)
    8 / 2014 (0.40%)
    11 / 2040 (0.54%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 11
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis infected
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    1 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected fistula
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Nosocomial infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreas infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    17 / 2014 (0.84%)
    46 / 2014 (2.28%)
    54 / 2040 (2.65%)
    16 / 2040 (0.78%)
         occurrences causally related to treatment / all
    1 / 18
    1 / 50
    0 / 59
    0 / 17
         deaths causally related to treatment / all
    1 / 4
    1 / 9
    0 / 8
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    Sialoadenitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    8 / 2014 (0.40%)
    21 / 2014 (1.04%)
    21 / 2040 (1.03%)
    8 / 2040 (0.39%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 26
    0 / 22
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
    Viral diarrhoea
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    1 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 12-Month Double-blind Period: Alendronate 70 mg QW Overall Study: Alendronate / Alendronate Overall Study: Romosozumab / Alendronate 12-Month Double-blind Period: Romosozumab 210 mg QM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1545 / 2014 (76.71%)
    1739 / 2014 (86.35%)
    1714 / 2040 (84.02%)
    1492 / 2040 (73.14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Adrenal neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Adrenal adenoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Adenoma benign
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    3 / 2014 (0.15%)
    17 / 2014 (0.84%)
    13 / 2040 (0.64%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    20
    16
    4
    Angiomyolipoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Benign lung neoplasm
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    2
    1
    Benign female reproductive tract neoplasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Benign breast neoplasm
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    4
    3
    3
    Benign neoplasm of eyelid
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Benign neoplasm
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    1
    5
    3
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    8 / 2040 (0.39%)
    6 / 2040 (0.29%)
         occurrences all number
    2
    5
    8
    6
    Bowen's disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Breast cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Benign renal neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Breast fibroma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Colon neoplasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Colon adenoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Essential thrombocythaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Eye naevus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Fibroma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemangioma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Haemangioma of bone
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Haemangioma of liver
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    3
    5
    4
    Hepatic neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infected neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lipoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    7 / 2014 (0.35%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    7
    2
    2
    Lung neoplasm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Malignant melanoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    3
    1
    Lymphoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Melanocytic naevus
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    3
    4
    2
    Malignant neoplasm of eyelid
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Meningioma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Monoclonal gammopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Neoplasm malignant
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Non-Hodgkin's lymphoma unspecified histology indolent stage I
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Oesophageal adenocarcinoma stage 0
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Osteoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Osteochondroma
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Primary myelofibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyogenic granuloma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rectal adenoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Renal neoplasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Retroperitoneal cancer
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    6
    5
    4
    Skin papilloma
         subjects affected / exposed
    5 / 2014 (0.25%)
    9 / 2014 (0.45%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    5
    9
    4
    4
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    4
    1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Sweat gland tumour
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Thyroid cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Vulval cancer
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Angiosclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Aortic aneurysm
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    3
    3
    2
    Aortic arteriosclerosis
         subjects affected / exposed
    9 / 2014 (0.45%)
    15 / 2014 (0.74%)
    27 / 2040 (1.32%)
    11 / 2040 (0.54%)
         occurrences all number
    9
    16
    28
    11
    Aortic dilatation
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    3
    2
    Aortic calcification
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Aortic elongation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aortic disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Aortic stenosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    6
    4
    1
    Aortic thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Arterial insufficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arteriosclerosis
         subjects affected / exposed
    8 / 2014 (0.40%)
    21 / 2014 (1.04%)
    17 / 2040 (0.83%)
    7 / 2040 (0.34%)
         occurrences all number
    8
    22
    17
    7
    Arterial stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    7 / 2040 (0.34%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    7
    2
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Circulatory collapse
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    7
    3
    0
    Haematoma
         subjects affected / exposed
    19 / 2014 (0.94%)
    43 / 2014 (2.14%)
    30 / 2040 (1.47%)
    14 / 2040 (0.69%)
         occurrences all number
    21
    51
    35
    17
    Essential hypertension
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    3
    3
    1
    Diastolic hypotension
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    130 / 2014 (6.45%)
    232 / 2014 (11.52%)
    233 / 2040 (11.42%)
    113 / 2040 (5.54%)
         occurrences all number
    139
    270
    275
    125
    Hot flush
         subjects affected / exposed
    5 / 2014 (0.25%)
    5 / 2014 (0.25%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    5
    5
    6
    4
    Hypertensive angiopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Hypertensive crisis
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    12 / 2040 (0.59%)
    9 / 2040 (0.44%)
         occurrences all number
    3
    6
    12
    9
    Hypertensive emergency
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ischaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hypotension
         subjects affected / exposed
    10 / 2014 (0.50%)
    15 / 2014 (0.74%)
    10 / 2040 (0.49%)
    6 / 2040 (0.29%)
         occurrences all number
    11
    17
    10
    6
    Intermittent claudication
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    2
    1
    Labile hypertension
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Labile blood pressure
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Lymphostasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Microangiopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    5
    1
    0
    Lymphoedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    6
    1
    Orthostatic hypotension
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    5
    1
    Pallor
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    9 / 2040 (0.44%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    7
    9
    4
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Peripheral ischaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences all number
    1
    3
    10
    6
    Peripheral venous disease
         subjects affected / exposed
    5 / 2014 (0.25%)
    17 / 2014 (0.84%)
    19 / 2040 (0.93%)
    8 / 2040 (0.39%)
         occurrences all number
    5
    19
    19
    8
    Phlebitis
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    4
    8
    8
    4
    Phlebitis deep
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Phlebitis superficial
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    3
    5
    2
    Poor peripheral circulation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    4
    1
    Post thrombotic syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    3
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Subgaleal haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    6
    3
    2
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    2
    4
    4
    Thrombosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    2
    2
    Varicophlebitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Varicose ulceration
         subjects affected / exposed
    4 / 2014 (0.20%)
    10 / 2014 (0.50%)
    7 / 2040 (0.34%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    12
    8
    1
    Varicose vein
         subjects affected / exposed
    14 / 2014 (0.70%)
    34 / 2014 (1.69%)
    24 / 2040 (1.18%)
    14 / 2040 (0.69%)
         occurrences all number
    15
    38
    24
    14
    Varicose vein ruptured
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vascular calcification
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Vascular insufficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Vasculitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vasodilatation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vena cava thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Venous thrombosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Surgical and medical procedures
    Blepharoplasty
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dental care
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Female genital operation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intervertebral disc operation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nerve block
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral surgery
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Skin neoplasm excision
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal fusion surgery
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth extraction
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Suture insertion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Administration site erythema
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    2
    Administration site haematoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Administration site pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    2
    2
    Administration site pruritus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Administration site reaction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Administration site swelling
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Adverse drug reaction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Asthenia
         subjects affected / exposed
    52 / 2014 (2.58%)
    84 / 2014 (4.17%)
    74 / 2040 (3.63%)
    49 / 2040 (2.40%)
         occurrences all number
    57
    101
    85
    56
    Axillary pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Calcinosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Catheter site extravasation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    8
    6
    4
    Chest pain
         subjects affected / exposed
    12 / 2014 (0.60%)
    28 / 2014 (1.39%)
    21 / 2040 (1.03%)
    7 / 2040 (0.34%)
         occurrences all number
    14
    32
    22
    8
    Chills
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    9 / 2040 (0.44%)
    7 / 2040 (0.34%)
         occurrences all number
    1
    1
    10
    8
    Complication associated with device
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Drug intolerance
         subjects affected / exposed
    8 / 2014 (0.40%)
    14 / 2014 (0.70%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    8
    14
    5
    5
    Discomfort
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    5
    7
    3
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Exercise tolerance increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Extravasation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye complication associated with device
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Face oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    2
    Facial pain
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    5
    4
    1
    Fatigue
         subjects affected / exposed
    23 / 2014 (1.14%)
    38 / 2014 (1.89%)
    30 / 2040 (1.47%)
    21 / 2040 (1.03%)
         occurrences all number
    23
    41
    30
    21
    Feeling abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Feeling hot
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Foreign body reaction
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    General physical health deterioration
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Gait disturbance
         subjects affected / exposed
    3 / 2014 (0.15%)
    10 / 2014 (0.50%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    10
    3
    0
    Generalised oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Hernia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Impaired healing
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    3
    0
    Impaired self-care
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    26 / 2014 (1.29%)
    32 / 2014 (1.59%)
    17 / 2040 (0.83%)
    13 / 2040 (0.64%)
         occurrences all number
    26
    36
    17
    13
    Injection site bruising
         subjects affected / exposed
    7 / 2014 (0.35%)
    7 / 2014 (0.35%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    8
    8
    3
    3
    Injection site erythema
         subjects affected / exposed
    9 / 2014 (0.45%)
    9 / 2014 (0.45%)
    26 / 2040 (1.27%)
    26 / 2040 (1.27%)
         occurrences all number
    9
    9
    53
    53
    Injection site haematoma
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    2
    4
    4
    Injection site haemorrhage
         subjects affected / exposed
    7 / 2014 (0.35%)
    7 / 2014 (0.35%)
    10 / 2040 (0.49%)
    10 / 2040 (0.49%)
         occurrences all number
    7
    7
    13
    13
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Injection site inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Injection site macule
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Injection site oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    24 / 2014 (1.19%)
    24 / 2014 (1.19%)
    32 / 2040 (1.57%)
    32 / 2040 (1.57%)
         occurrences all number
    36
    36
    70
    70
    Injection site papule
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Injection site pruritus
         subjects affected / exposed
    4 / 2014 (0.20%)
    4 / 2014 (0.20%)
    17 / 2040 (0.83%)
    17 / 2040 (0.83%)
         occurrences all number
    4
    4
    26
    26
    Injection site rash
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    8 / 2040 (0.39%)
    8 / 2040 (0.39%)
         occurrences all number
    2
    2
    12
    12
    Injection site swelling
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    7 / 2040 (0.34%)
    7 / 2040 (0.34%)
         occurrences all number
    1
    1
    11
    11
    Injection site urticaria
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    1
    5
    5
    Injection site vesicles
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Injection site warmth
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Injury associated with device
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Local swelling
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Localised oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Malaise
         subjects affected / exposed
    14 / 2014 (0.70%)
    23 / 2014 (1.14%)
    21 / 2040 (1.03%)
    7 / 2040 (0.34%)
         occurrences all number
    16
    26
    22
    7
    Mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Medical device pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Medical device site joint pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mucosal atrophy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Mucosal hyperaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nodule
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    4
    9
    2
    0
    Non-cardiac chest pain
         subjects affected / exposed
    25 / 2014 (1.24%)
    39 / 2014 (1.94%)
    30 / 2040 (1.47%)
    18 / 2040 (0.88%)
         occurrences all number
    29
    48
    31
    18
    Oedema
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    6
    3
    1
    Oedema peripheral
         subjects affected / exposed
    37 / 2014 (1.84%)
    81 / 2014 (4.02%)
    64 / 2040 (3.14%)
    34 / 2040 (1.67%)
         occurrences all number
    42
    99
    70
    34
    Pain
         subjects affected / exposed
    10 / 2014 (0.50%)
    21 / 2014 (1.04%)
    19 / 2040 (0.93%)
    12 / 2040 (0.59%)
         occurrences all number
    13
    26
    19
    12
    Peripheral swelling
         subjects affected / exposed
    13 / 2014 (0.65%)
    35 / 2014 (1.74%)
    36 / 2040 (1.76%)
    12 / 2040 (0.59%)
         occurrences all number
    14
    41
    47
    12
    Polyp
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pseudocyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    18 / 2014 (0.89%)
    33 / 2014 (1.64%)
    28 / 2040 (1.37%)
    14 / 2040 (0.69%)
         occurrences all number
    19
    36
    39
    20
    Sensation of foreign body
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Suprapubic pain
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Swelling
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaccination site rash
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vessel puncture site erythema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vessel puncture site swelling
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Xerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    2
    4
    3
    Allergy to chemicals
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    3
    2
    Drug hypersensitivity
         subjects affected / exposed
    7 / 2014 (0.35%)
    12 / 2014 (0.60%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    7
    12
    7
    3
    Food allergy
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Hypersensitivity
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    7
    6
    4
    Iodine allergy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mite allergy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Oral allergy syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    10 / 2040 (0.49%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    6
    11
    4
    Social circumstances
    Diet noncompliance
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immobile
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Adnexa uteri cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Atrophic vulvovaginitis
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    4
    6
    6
    4
    Breast calcifications
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Breast cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Breast discharge
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Breast disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Breast enlargement
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Breast inflammation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Breast haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Breast mass
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    3
    1
    Breast pain
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    5
    2
    Cervical dysplasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cervical polyp
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Cervix inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Endometrial disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Cystocele
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    4
    1
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Endometrial hypertrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Endometriosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fallopian tube cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Genital discharge
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Genital haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Genital pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Genital prolapse
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Genital tract inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Genital ulceration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Menopausal symptoms
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Metrorrhagia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Nipple disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ovarian cyst
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    6
    1
    Pelvic cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pelvic pain
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    5
    2
    Perineal pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rectocele
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Retracted nipple
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Uterine cyst
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Uterine polyp
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    5
    0
    0
    Uterine prolapse
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    6
    4
    2
    Vaginal discharge
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Vaginal dysplasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    0
    3
    6
    4
    Vaginal prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vaginal ulceration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vulva cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginal burning sensation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vulvovaginal dryness
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    4
    1
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    7
    3
    2
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Allergic bronchitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Allergic cough
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    6 / 2040 (0.29%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    6
    2
    Allergic respiratory disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asthma
         subjects affected / exposed
    10 / 2014 (0.50%)
    22 / 2014 (1.09%)
    22 / 2040 (1.08%)
    10 / 2040 (0.49%)
         occurrences all number
    10
    24
    28
    12
    Allergic respiratory symptom
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Atelectasis
         subjects affected / exposed
    6 / 2014 (0.30%)
    11 / 2014 (0.55%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    6
    11
    1
    0
    Asthmatic crisis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    1
    1
    Bronchial obstruction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchiectasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Bronchitis chronic
         subjects affected / exposed
    6 / 2014 (0.30%)
    17 / 2014 (0.84%)
    8 / 2040 (0.39%)
    2 / 2040 (0.10%)
         occurrences all number
    6
    18
    8
    2
    Bronchospasm
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    2
    3
    1
    Catarrh
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences all number
    4
    6
    10
    5
    Choking
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    24 / 2014 (1.19%)
    49 / 2014 (2.43%)
    35 / 2040 (1.72%)
    21 / 2040 (1.03%)
         occurrences all number
    30
    66
    60
    25
    Chronic respiratory failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cough
         subjects affected / exposed
    55 / 2014 (2.73%)
    118 / 2014 (5.86%)
    147 / 2040 (7.21%)
    74 / 2040 (3.63%)
         occurrences all number
    62
    145
    172
    81
    Dry throat
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Dysphonia
         subjects affected / exposed
    7 / 2014 (0.35%)
    12 / 2014 (0.60%)
    8 / 2040 (0.39%)
    6 / 2040 (0.29%)
         occurrences all number
    7
    12
    9
    6
    Dyspnoea
         subjects affected / exposed
    11 / 2014 (0.55%)
    25 / 2014 (1.24%)
    29 / 2040 (1.42%)
    12 / 2040 (0.59%)
         occurrences all number
    11
    28
    39
    15
    Dyspnoea exertional
         subjects affected / exposed
    5 / 2014 (0.25%)
    10 / 2014 (0.50%)
    12 / 2040 (0.59%)
    7 / 2040 (0.34%)
         occurrences all number
    5
    10
    12
    7
    Epistaxis
         subjects affected / exposed
    5 / 2014 (0.25%)
    11 / 2014 (0.55%)
    18 / 2040 (0.88%)
    8 / 2040 (0.39%)
         occurrences all number
    7
    15
    26
    11
    Emphysema
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    7
    6
    1
    Haemoptysis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    3
    3
    3
    Hiccups
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    2
    Hydrothorax
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypoventilation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Increased upper airway secretion
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Interstitial lung disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Laryngitis allergic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Lower respiratory tract inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Lung disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Nasal congestion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    3
    1
    Lung hyperinflation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Nasal dryness
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Nasal mucosal hypertrophy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nasal polyps
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nasal pruritus
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal septum deviation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    2
    4
    3
    Nasal turbinate hypertrophy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    8 / 2014 (0.40%)
    18 / 2014 (0.89%)
    16 / 2040 (0.78%)
    9 / 2040 (0.44%)
         occurrences all number
    9
    19
    17
    9
    Pharyngeal inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Pharyngeal ulceration
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pleural adhesion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pleural calcification
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pleural effusion
         subjects affected / exposed
    3 / 2014 (0.15%)
    13 / 2014 (0.65%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    13
    5
    1
    Pleural thickening
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pleurisy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pneumonitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Productive cough
         subjects affected / exposed
    9 / 2014 (0.45%)
    11 / 2014 (0.55%)
    16 / 2040 (0.78%)
    10 / 2040 (0.49%)
         occurrences all number
    10
    12
    17
    10
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Pulmonary calcification
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    2
    2
    Pulmonary granuloma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    3 / 2014 (0.15%)
    21 / 2014 (1.04%)
    12 / 2040 (0.59%)
    7 / 2040 (0.34%)
         occurrences all number
    3
    21
    12
    7
    Pulmonary infarction
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary mass
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    2
    1
    Pulmonary oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Rales
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary vascular disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    1
    4
    4
    Respiratory alkalosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory distress
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    3
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    7 / 2040 (0.34%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    7
    1
    Rhinitis allergic
         subjects affected / exposed
    7 / 2014 (0.35%)
    14 / 2014 (0.70%)
    15 / 2040 (0.74%)
    4 / 2040 (0.20%)
         occurrences all number
    7
    14
    18
    4
    Sinus congestion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    4
    0
    Sputum increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Tonsillar cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Throat irritation
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    3
    2
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vocal cord cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wheezing
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Abnormal dreams
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Acute stress disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Adjustment disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    2
    4
    4
    Affective disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Agitation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anxiety
         subjects affected / exposed
    15 / 2014 (0.74%)
    28 / 2014 (1.39%)
    28 / 2040 (1.37%)
    14 / 2040 (0.69%)
         occurrences all number
    16
    30
    28
    14
    Anxiety disorder
         subjects affected / exposed
    3 / 2014 (0.15%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    8
    8
    4
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Apathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bipolar disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bruxism
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Compulsive hoarding
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Confusional state
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    5
    1
    Daydreaming
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Depression
         subjects affected / exposed
    41 / 2014 (2.04%)
    83 / 2014 (4.12%)
    80 / 2040 (3.92%)
    42 / 2040 (2.06%)
         occurrences all number
    43
    93
    93
    45
    Depressed mood
         subjects affected / exposed
    3 / 2014 (0.15%)
    12 / 2014 (0.60%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences all number
    3
    12
    8
    5
    Delirium
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    8
    3
    0
    Disorientation
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    3
    3
    3
    Depressive symptom
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Drug use disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Emotional distress
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Feelings of worthlessness
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    2
    Frustration tolerance decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    4
    1
    Grief reaction
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hallucination
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Hallucination, visual
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Hallucinations, mixed
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Insomnia
         subjects affected / exposed
    36 / 2014 (1.79%)
    74 / 2014 (3.67%)
    57 / 2040 (2.79%)
    34 / 2040 (1.67%)
         occurrences all number
    38
    81
    61
    35
    Initial insomnia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Irritability
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Major depression
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    4
    1
    0
    Mania
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mental disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Mental status changes
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Middle insomnia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Mood altered
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Mood disorder due to a general medical condition
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervousness
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Nightmare
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Panic attack
         subjects affected / exposed
    4 / 2014 (0.20%)
    5 / 2014 (0.25%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    7
    9
    3
    2
    Panic disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Persistent depressive disorder
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    3
    1
    1
    Pica
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Schizophrenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Senile psychosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Somatic symptom disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Sleep disorder
         subjects affected / exposed
    8 / 2014 (0.40%)
    12 / 2014 (0.60%)
    8 / 2040 (0.39%)
    3 / 2040 (0.15%)
         occurrences all number
    8
    12
    8
    3
    Stress
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Tension
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Product issues
    Device breakage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Device failure
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Device loosening
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Biliary colic
         subjects affected / exposed
    4 / 2014 (0.20%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    4
    4
    2
    Bile duct stone
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Biliary dilatation
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    4
    2
    1
    Cholangitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Cholecystitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    3
    1
    Cholecystitis acute
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cholecystitis chronic
         subjects affected / exposed
    5 / 2014 (0.25%)
    7 / 2014 (0.35%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    5
    7
    2
    0
    Cholelithiasis
         subjects affected / exposed
    12 / 2014 (0.60%)
    28 / 2014 (1.39%)
    22 / 2040 (1.08%)
    12 / 2040 (0.59%)
         occurrences all number
    12
    29
    22
    12
    Drug-induced liver injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gallbladder polyp
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Granulomatous liver disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hepatic atrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic cyst
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    17 / 2040 (0.83%)
    9 / 2040 (0.44%)
         occurrences all number
    4
    9
    17
    9
    Hepatic function abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hepatic steatosis
         subjects affected / exposed
    6 / 2014 (0.30%)
    21 / 2014 (1.04%)
    12 / 2040 (0.59%)
    3 / 2040 (0.15%)
         occurrences all number
    6
    21
    12
    3
    Hepatic lesion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Hepatitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hepatobiliary disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Jaundice
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    2
    3
    3
    Liver injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    5
    2
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aortic bruit
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Aspiration joint
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    5
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blood calcium increased
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Blood cholesterol abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Blood chloride decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    2
    2
    Blood glucose increased
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    3
    0
    Blood folate decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Blood magnesium decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Blood potassium abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Blood pressure abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    3
    1
    Blood potassium increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blood pressure ambulatory
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood pressure decreased
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Blood pressure increased
         subjects affected / exposed
    10 / 2014 (0.50%)
    20 / 2014 (0.99%)
    17 / 2040 (0.83%)
    8 / 2040 (0.39%)
         occurrences all number
    12
    24
    19
    8
    Blood urea increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Blood triglycerides increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Body mass index increased
         subjects affected / exposed
    6 / 2014 (0.30%)
    12 / 2014 (0.60%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    6
    13
    11
    3
    Blood uric acid increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Body height decreased
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    4
    2
    Bone density abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Body temperature increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    3
    2
    Bone density decreased
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Brain scan abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Carcinoembryonic antigen increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Cardiac function test abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Computerised tomogram head abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Chest X-ray abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Cardiac murmur
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    5 / 2040 (0.25%)
    0 / 2040 (0.00%)
         occurrences all number
    4
    8
    5
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Escherichia test positive
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Glomerular filtration rate increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    3
    6
    5
    Haemoglobin
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemoglobin abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    4
    1
    Haemoglobin increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    5
    2
    Heart rate irregular
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    3
    2
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    4
    2
    Inflammatory marker increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    International normalised ratio decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Intestinal transit time decreased
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Intraocular pressure increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Klebsiella test positive
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lymphocyte count increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Mycoplasma test positive
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Monocyte count increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    3
    3
    Nuclear magnetic resonance imaging brain abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Occult blood positive
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Occult blood
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Platelet count decreased
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Renal function test abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Staphylococcus test positive
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Thyroxine increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    1
    1
    Ultrasound liver abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ultrasound uterus abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Urine analysis abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urine output increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin D decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Weight decreased
         subjects affected / exposed
    22 / 2014 (1.09%)
    49 / 2014 (2.43%)
    33 / 2040 (1.62%)
    14 / 2040 (0.69%)
         occurrences all number
    23
    53
    36
    14
    Weight increased
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    6
    3
    2
    White blood cell count decreased
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Accident
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Accident at home
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Accidental exposure to product
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Accidental overdose
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acetabulum fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Anaemia postoperative
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    3
    6
    4
    Animal bite
         subjects affected / exposed
    5 / 2014 (0.25%)
    14 / 2014 (0.70%)
    11 / 2040 (0.54%)
    6 / 2040 (0.29%)
         occurrences all number
    5
    14
    11
    6
    Arterial injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    3 / 2014 (0.15%)
    8 / 2014 (0.40%)
    10 / 2040 (0.49%)
    5 / 2040 (0.25%)
         occurrences all number
    3
    9
    11
    6
    Arthropod sting
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Back injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    1
    4
    3
    Bladder injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bone contusion
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    6
    1
    0
    Brain contusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Burns first degree
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Burns second degree
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    3
    2
    Chemical burn of skin
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chemical cystitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Chemical poisoning
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Chest injury
         subjects affected / exposed
    8 / 2014 (0.40%)
    33 / 2014 (1.64%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    8
    34
    6
    4
    Chillblains
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Clavicle fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Commotio retinae
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Concussion
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    5
    2
    0
    Confusion postoperative
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    71 / 2014 (3.53%)
    161 / 2014 (7.99%)
    115 / 2040 (5.64%)
    51 / 2040 (2.50%)
         occurrences all number
    84
    242
    154
    58
    Corneal abrasion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    6
    0
    Craniocerebral injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    5 / 2014 (0.25%)
    10 / 2040 (0.49%)
    5 / 2040 (0.25%)
         occurrences all number
    0
    5
    10
    5
    Deep vein thrombosis postoperative
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dislocation of vertebra
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Ear canal injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear canal abrasion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epicondylitis
         subjects affected / exposed
    8 / 2014 (0.40%)
    13 / 2014 (0.65%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    9
    14
    4
    3
    Epidural haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Excoriation
         subjects affected / exposed
    3 / 2014 (0.15%)
    9 / 2014 (0.45%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    6
    13
    4
    1
    Eye contusion
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Eye injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Eyelid contusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Face injury
         subjects affected / exposed
    8 / 2014 (0.40%)
    13 / 2014 (0.65%)
    10 / 2040 (0.49%)
    4 / 2040 (0.20%)
         occurrences all number
    8
    13
    12
    5
    Facial bones fracture
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    2
    0
    Fall
         subjects affected / exposed
    151 / 2014 (7.50%)
    342 / 2014 (16.98%)
    287 / 2040 (14.07%)
    127 / 2040 (6.23%)
         occurrences all number
    192
    587
    479
    165
    Fat overload syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Femoral neck fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Femur fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Fibula fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    1
    7
    3
    Foot fracture
         subjects affected / exposed
    5 / 2014 (0.25%)
    12 / 2014 (0.60%)
    15 / 2040 (0.74%)
    3 / 2040 (0.15%)
         occurrences all number
    5
    12
    16
    3
    Foreign body
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Foreign body in eye
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    1
    1
    Fractured ischium
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    2
    1
    Fractured sacrum
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastrointestinal injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Frostbite
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gingival injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Hand fracture
         subjects affected / exposed
    5 / 2014 (0.25%)
    17 / 2014 (0.84%)
    8 / 2040 (0.39%)
    2 / 2040 (0.10%)
         occurrences all number
    5
    17
    8
    2
    Head injury
         subjects affected / exposed
    11 / 2014 (0.55%)
    26 / 2014 (1.29%)
    17 / 2040 (0.83%)
    4 / 2040 (0.20%)
         occurrences all number
    11
    28
    18
    4
    Heart injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Humerus fracture
         subjects affected / exposed
    7 / 2014 (0.35%)
    19 / 2014 (0.94%)
    18 / 2040 (0.88%)
    3 / 2040 (0.15%)
         occurrences all number
    7
    19
    18
    3
    Iliotibial band syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ilium fracture
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Incisional hernia
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Injury
         subjects affected / exposed
    5 / 2014 (0.25%)
    9 / 2014 (0.45%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    5
    10
    5
    2
    Jaw fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Joint dislocation
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    7 / 2040 (0.34%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    6
    8
    2
    Joint injury
         subjects affected / exposed
    16 / 2014 (0.79%)
    50 / 2014 (2.48%)
    43 / 2040 (2.11%)
    16 / 2040 (0.78%)
         occurrences all number
    16
    63
    56
    17
    Laceration
         subjects affected / exposed
    14 / 2014 (0.70%)
    24 / 2014 (1.19%)
    19 / 2040 (0.93%)
    10 / 2040 (0.49%)
         occurrences all number
    14
    25
    22
    10
    Ligament injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ligament rupture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Ligament sprain
         subjects affected / exposed
    13 / 2014 (0.65%)
    32 / 2014 (1.59%)
    33 / 2040 (1.62%)
    13 / 2040 (0.64%)
         occurrences all number
    15
    35
    34
    13
    Limb crushing injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Limb injury
         subjects affected / exposed
    24 / 2014 (1.19%)
    54 / 2014 (2.68%)
    58 / 2040 (2.84%)
    19 / 2040 (0.93%)
         occurrences all number
    25
    71
    72
    20
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Lip injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    4
    1
    Multiple injuries
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Muscle injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    1
    4
    3
    Muscle rupture
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Muscle strain
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    9 / 2040 (0.44%)
    6 / 2040 (0.29%)
         occurrences all number
    3
    7
    11
    6
    Nasal injury
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    3
    3
    3
    Neck injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    3
    1
    Overdose
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    5
    1
    1
    Patella fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    7 / 2040 (0.34%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    7
    7
    4
    Pelvic organ injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Perineal injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Periorbital haematoma
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    3
    3
    2
    Periorbital haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral nerve injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Post concussion syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Post procedural complication
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    1
    Post procedural fistula
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Post procedural oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Post procedural hypothyroidism
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Post procedural swelling
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    7 / 2014 (0.35%)
    8 / 2014 (0.40%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    7
    8
    3
    1
    Postoperative fever
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Procedural complication
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Procedural pain
         subjects affected / exposed
    5 / 2014 (0.25%)
    10 / 2014 (0.50%)
    13 / 2040 (0.64%)
    7 / 2040 (0.34%)
         occurrences all number
    5
    11
    16
    8
    Procedural nausea
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pubis fracture
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    6
    2
    1
    Radiation associated pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Radiation leukopenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Radius fracture
         subjects affected / exposed
    28 / 2014 (1.39%)
    50 / 2014 (2.48%)
    48 / 2040 (2.35%)
    22 / 2040 (1.08%)
         occurrences all number
    29
    51
    49
    22
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    2
    3
    1
    Rib fracture
         subjects affected / exposed
    10 / 2014 (0.50%)
    25 / 2014 (1.24%)
    19 / 2040 (0.93%)
    8 / 2040 (0.39%)
         occurrences all number
    10
    32
    22
    8
    Scar
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Seroma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Scratch
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Skin abrasion
         subjects affected / exposed
    7 / 2014 (0.35%)
    23 / 2014 (1.14%)
    19 / 2040 (0.93%)
    7 / 2040 (0.34%)
         occurrences all number
    11
    35
    23
    9
    Skeletal injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Skin injury
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    4
    3
    0
    Skin wound
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skull fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Soft tissue injury
         subjects affected / exposed
    13 / 2014 (0.65%)
    27 / 2014 (1.34%)
    37 / 2040 (1.81%)
    23 / 2040 (1.13%)
         occurrences all number
    14
    34
    48
    27
    Spinal column injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    6
    1
    Spinal compression fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Spinal fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    5
    6
    3
    Sternal fracture
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Stoma obstruction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Subcutaneous haematoma
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    1
    1
    Subdural haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Sunburn
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    2
    2
    Synovial rupture
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tendon injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Tendon rupture
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    3
    5
    5
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Tibia fracture
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    3
    2
    Thermal burn
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    12 / 2040 (0.59%)
    7 / 2040 (0.34%)
         occurrences all number
    3
    8
    13
    7
    Tongue injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Tooth avulsion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Tooth fracture
         subjects affected / exposed
    4 / 2014 (0.20%)
    11 / 2014 (0.55%)
    11 / 2040 (0.54%)
    3 / 2040 (0.15%)
         occurrences all number
    5
    13
    13
    4
    Toxicity to various agents
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Transfusion reaction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    2
    4
    3
    Traumatic haemothorax
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Traumatic lung injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vaccination complication
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Ulna fracture
         subjects affected / exposed
    17 / 2014 (0.84%)
    29 / 2014 (1.44%)
    27 / 2040 (1.32%)
    14 / 2040 (0.69%)
         occurrences all number
    17
    29
    27
    14
    Vaginal laceration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Wound haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Wound
         subjects affected / exposed
    6 / 2014 (0.30%)
    27 / 2014 (1.34%)
    25 / 2040 (1.23%)
    9 / 2040 (0.44%)
         occurrences all number
    6
    31
    25
    9
    Wound secretion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    1
    1
    Congenital, familial and genetic disorders
    Biliary hamartoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital cerebrovascular anomaly
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congenital cystic kidney disease
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Congenital hypercoagulation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Corneal dystrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Muscular dystrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Odontogenic cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Thalassaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tuberous sclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vertebral artery hypoplasia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Acute myocardial infarction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Angina pectoris
         subjects affected / exposed
    6 / 2014 (0.30%)
    12 / 2014 (0.60%)
    12 / 2040 (0.59%)
    8 / 2040 (0.39%)
         occurrences all number
    7
    13
    13
    8
    Angina unstable
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Aortic valve calcification
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Aortic valve disease mixed
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aortic valve incompetence
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    15 / 2040 (0.74%)
    9 / 2040 (0.44%)
         occurrences all number
    4
    8
    15
    9
    Aortic valve sclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    3
    1
    Arrhythmia
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    7
    5
    2
    Arrhythmia supraventricular
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    3
    1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    3
    5
    3
    Atrial fibrillation
         subjects affected / exposed
    10 / 2014 (0.50%)
    27 / 2014 (1.34%)
    29 / 2040 (1.42%)
    8 / 2040 (0.39%)
         occurrences all number
    11
    29
    33
    8
    Atrial flutter
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Atrial tachycardia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Atrioventricular block
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    3
    1
    Atrioventricular block complete
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Bradycardia
         subjects affected / exposed
    4 / 2014 (0.20%)
    10 / 2014 (0.50%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    11
    5
    1
    Bundle branch block
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Bundle branch block left
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    6 / 2040 (0.29%)
    0 / 2040 (0.00%)
         occurrences all number
    4
    7
    6
    0
    Bundle branch block right
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Cardiac discomfort
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Cardiac failure
         subjects affected / exposed
    12 / 2014 (0.60%)
    25 / 2014 (1.24%)
    22 / 2040 (1.08%)
    8 / 2040 (0.39%)
         occurrences all number
    12
    27
    23
    8
    Cardiac failure chronic
         subjects affected / exposed
    7 / 2014 (0.35%)
    15 / 2014 (0.74%)
    12 / 2040 (0.59%)
    5 / 2040 (0.25%)
         occurrences all number
    8
    16
    12
    5
    Cardiac failure congestive
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    6
    1
    Cardiac hypertrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac septal hypertrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Cardiac valve disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    1
    1
    Cardiac valve sclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiomegaly
         subjects affected / exposed
    1 / 2014 (0.05%)
    8 / 2014 (0.40%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences all number
    1
    8
    9
    5
    Cardiomyopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    3
    3
    3
    Cardiovascular disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    2
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conduction disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    1
    1
    Coronary artery disease
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    9 / 2040 (0.44%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    9
    9
    3
    Coronary artery stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Defect conduction intraventricular
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Degenerative aortic valve disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Degenerative mitral valve disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Diastolic dysfunction
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    1
    1
    Dilatation atrial
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    4
    1
    Dilatation ventricular
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Extrasystoles
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    2
    7
    4
    Heart valve incompetence
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    6
    4
    1
    Hypertensive cardiomyopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    6 / 2040 (0.29%)
    5 / 2040 (0.25%)
         occurrences all number
    0
    1
    6
    5
    Left atrial dilatation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Left atrial enlargement
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Left atrial hypertrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Left ventricular dilatation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    8 / 2040 (0.39%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    8
    1
    Left ventricular failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    4
    4
    2
    Mitral valve disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 2014 (0.25%)
    24 / 2014 (1.19%)
    26 / 2040 (1.27%)
    11 / 2040 (0.54%)
         occurrences all number
    6
    26
    26
    11
    Mitral valve prolapse
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    4
    0
    0
    Mitral valve sclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    2
    2
    Mitral valve stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Myocardial fibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Myocardial infarction
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Myocardial ischaemia
         subjects affected / exposed
    3 / 2014 (0.15%)
    10 / 2014 (0.50%)
    14 / 2040 (0.69%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    10
    15
    4
    Nodal rhythm
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Palpitations
         subjects affected / exposed
    7 / 2014 (0.35%)
    15 / 2014 (0.74%)
    13 / 2040 (0.64%)
    9 / 2040 (0.44%)
         occurrences all number
    8
    16
    14
    9
    Pericardial effusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    0
    5
    3
    Postinfarction angina
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary valve incompetence
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Right atrial dilatation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Right ventricular failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Sinus bradycardia
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    3
    5
    1
    Sinus node dysfunction
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    2
    2
    Supraventricular extrasystoles
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    4 / 2040 (0.20%)
         occurrences all number
    4
    8
    8
    4
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Systolic dysfunction
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    5 / 2014 (0.25%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences all number
    5
    8
    10
    6
    Tricuspid valve incompetence
         subjects affected / exposed
    4 / 2014 (0.20%)
    22 / 2014 (1.09%)
    13 / 2040 (0.64%)
    8 / 2040 (0.39%)
         occurrences all number
    4
    22
    13
    8
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    2
    5
    3
    Ventricular extrasystoles
         subjects affected / exposed
    6 / 2014 (0.30%)
    7 / 2014 (0.35%)
    7 / 2040 (0.34%)
    4 / 2040 (0.20%)
         occurrences all number
    6
    7
    7
    4
    Ventricular fibrillation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    5 / 2014 (0.25%)
    10 / 2014 (0.50%)
    10 / 2040 (0.49%)
    7 / 2040 (0.34%)
         occurrences all number
    5
    11
    11
    7
    Amnestic disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Amputation stump pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anticholinergic syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Aphasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    3
    2
    Ataxia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Balance disorder
         subjects affected / exposed
    6 / 2014 (0.30%)
    9 / 2014 (0.45%)
    7 / 2040 (0.34%)
    5 / 2040 (0.25%)
         occurrences all number
    6
    10
    7
    5
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aura
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Brain oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Brain injury
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    3
    2
    Carotid artery stenosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    6
    6
    3
    Burning sensation
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    7
    4
    2
    Carpal tunnel syndrome
         subjects affected / exposed
    8 / 2014 (0.40%)
    18 / 2014 (0.89%)
    13 / 2040 (0.64%)
    8 / 2040 (0.39%)
         occurrences all number
    8
    18
    13
    8
    Central nervous system necrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Central nervous system lesion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Cerebellar atrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral amyloid angiopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral artery embolism
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral arteriosclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences all number
    1
    4
    8
    5
    Cerebral atrophy
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    5
    7
    3
    Cerebral calcification
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral artery stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cerebral circulatory failure
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cerebral hypoperfusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral haematoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Cerebral ischaemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    3
    0
    Cerebral infarction
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral ventricle dilatation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Cerebral microangiopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cerebrosclerosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Cerebrovascular accident
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    3
    3
    1
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Cerebrovascular disorder
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    10 / 2040 (0.49%)
    8 / 2040 (0.39%)
         occurrences all number
    3
    5
    10
    8
    Cervical radiculopathy
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    3
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Circadian rhythm sleep disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cognitive disorder
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    8
    8
    3
    Coma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Dementia
         subjects affected / exposed
    4 / 2014 (0.20%)
    14 / 2014 (0.70%)
    19 / 2040 (0.93%)
    6 / 2040 (0.29%)
         occurrences all number
    4
    14
    19
    6
    Dementia Alzheimer's type
         subjects affected / exposed
    3 / 2014 (0.15%)
    11 / 2014 (0.55%)
    8 / 2040 (0.39%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    12
    8
    3
    Diabetic neuropathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Disturbance in attention
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dizziness
         subjects affected / exposed
    80 / 2014 (3.97%)
    152 / 2014 (7.55%)
    149 / 2040 (7.30%)
    85 / 2040 (4.17%)
         occurrences all number
    91
    193
    190
    100
    Dizziness postural
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    3
    8
    4
    Dysaesthesia
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    3
    1
    Dysarthria
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Dysgeusia
         subjects affected / exposed
    5 / 2014 (0.25%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    5
    5
    1
    1
    Dyskinesia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Encephalopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Encephalomalacia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Epidural lipomatosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Essential tremor
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Epilepsy
         subjects affected / exposed
    4 / 2014 (0.20%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    5
    1
    1
    Facial neuralgia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Facial paralysis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    4
    0
    Gliosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    110 / 2014 (5.46%)
    190 / 2014 (9.43%)
    163 / 2040 (7.99%)
    106 / 2040 (5.20%)
         occurrences all number
    122
    241
    210
    128
    Hydrocephalus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hemiparesis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    5
    1
    Hypersomnia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    14 / 2014 (0.70%)
    26 / 2014 (1.29%)
    25 / 2040 (1.23%)
    12 / 2040 (0.59%)
         occurrences all number
    16
    32
    27
    13
    Hypertensive encephalopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypotonia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hypokinesia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    IIIrd nerve paralysis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Incoherent
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Intention tremor
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 2014 (0.05%)
    7 / 2014 (0.35%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    8
    2
    0
    Intracranial aneurysm
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    2
    2
    1
    Intracranial haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ischaemic stroke
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lacunar infarction
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    4
    3
    0
    Lethargy
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    2
    2
    2
    Lacunar stroke
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    9 / 2040 (0.44%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    5
    10
    4
    Leukoencephalopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    8 / 2014 (0.40%)
    7 / 2040 (0.34%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    12
    7
    1
    Memory impairment
         subjects affected / exposed
    10 / 2014 (0.50%)
    31 / 2014 (1.54%)
    34 / 2040 (1.67%)
    12 / 2040 (0.59%)
         occurrences all number
    10
    33
    36
    12
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Migraine
         subjects affected / exposed
    11 / 2014 (0.55%)
    13 / 2014 (0.65%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    13
    20
    5
    2
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Monoparesis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Multiple sclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Muscle spasticity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Myoclonus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nerve root compression
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Nervous system disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nerve compression
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neuralgia
         subjects affected / exposed
    7 / 2014 (0.35%)
    9 / 2014 (0.45%)
    10 / 2040 (0.49%)
    8 / 2040 (0.39%)
         occurrences all number
    8
    12
    10
    8
    Neuralgic amyotrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Neuritis
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    4
    0
    0
    Neurodegenerative disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    5
    7
    5
    Nystagmus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Occipital neuralgia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Notalgia paraesthetica
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Paresis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Parkinson's disease
         subjects affected / exposed
    1 / 2014 (0.05%)
    7 / 2014 (0.35%)
    11 / 2040 (0.54%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    8
    12
    3
    Paraesthesia
         subjects affected / exposed
    34 / 2014 (1.69%)
    53 / 2014 (2.63%)
    41 / 2040 (2.01%)
    28 / 2040 (1.37%)
         occurrences all number
    36
    58
    45
    30
    Parkinsonism
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    4
    2
    Partial seizures
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    4
    1
    Parosmia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral nerve lesion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Petit mal epilepsy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Polyneuropathy
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    3
    4
    4
    Post herpetic neuralgia
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    8
    5
    3
    Polyneuropathy alcoholic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    4
    5
    2
    Post-traumatic headache
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Rabbit syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Radicular pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Radicular syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Radiculopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    2
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    4
    2
    0
    Sciatica
         subjects affected / exposed
    22 / 2014 (1.09%)
    51 / 2014 (2.53%)
    48 / 2040 (2.35%)
    24 / 2040 (1.18%)
         occurrences all number
    23
    57
    57
    29
    Seizure
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    8
    2
    Senile dementia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seizure anoxic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Sensory disturbance
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Somnolence
         subjects affected / exposed
    7 / 2014 (0.35%)
    8 / 2014 (0.40%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    9
    11
    5
    3
    Speech disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    1
    Spinal claudication
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal cord disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal meningeal cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Subdural effusion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Stroke in evolution
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    11 / 2014 (0.55%)
    23 / 2014 (1.14%)
    32 / 2040 (1.57%)
    13 / 2040 (0.64%)
         occurrences all number
    11
    24
    41
    17
    Tension headache
         subjects affected / exposed
    5 / 2014 (0.25%)
    8 / 2014 (0.40%)
    10 / 2040 (0.49%)
    7 / 2040 (0.34%)
         occurrences all number
    6
    9
    11
    8
    Tremor
         subjects affected / exposed
    5 / 2014 (0.25%)
    16 / 2014 (0.79%)
    15 / 2040 (0.74%)
    8 / 2040 (0.39%)
         occurrences all number
    5
    16
    15
    8
    Transient ischaemic attack
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    1
    8
    3
    Trigeminal nerve disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Trigeminal neuritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    1
    Ulnar neuritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    VIth nerve disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vascular dementia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Vascular encephalopathy
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    2
    5
    4
    Vocal cord paresis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    White matter lesion
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    49 / 2014 (2.43%)
    113 / 2014 (5.61%)
    84 / 2040 (4.12%)
    41 / 2040 (2.01%)
         occurrences all number
    53
    128
    100
    43
    Anaemia megaloblastic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anaemia vitamin B6 deficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bicytopenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    2
    2
    Eosinophilia
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Granulocytopenia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Haemoconcentration
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Hyperchromic anaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Increased tendency to bruise
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 2014 (0.20%)
    12 / 2014 (0.60%)
    9 / 2040 (0.44%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    14
    9
    3
    Leukocytosis
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    7
    5
    2
    Leukopenia
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences all number
    4
    8
    10
    6
    Lymph node pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    3
    1
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Lymphocytosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    2
    2
    Lymphopenia
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    2
    1
    Microcytic anaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Neutropenia
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    4
    7
    3
    Neutrophilia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    1
    4
    4
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    4
    1
    Pancytopenia
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Pernicious anaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Purpura non-thrombocytopenic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retroperitoneal lymphadenopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 2014 (0.15%)
    13 / 2014 (0.65%)
    12 / 2040 (0.59%)
    5 / 2040 (0.25%)
         occurrences all number
    4
    16
    14
    5
    Thrombocytosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    8 / 2040 (0.39%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    3
    9
    5
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Cerumen impaction
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    11 / 2040 (0.54%)
    2 / 2040 (0.10%)
         occurrences all number
    5
    10
    12
    2
    Cupulolithiasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Deafness bilateral
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear canal erythema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear discomfort
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear pain
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    14 / 2040 (0.69%)
    4 / 2040 (0.20%)
         occurrences all number
    4
    11
    15
    4
    Ear pruritus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Excessive cerumen production
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    5
    1
    Hypoacusis
         subjects affected / exposed
    17 / 2014 (0.84%)
    34 / 2014 (1.69%)
    26 / 2040 (1.27%)
    10 / 2040 (0.49%)
         occurrences all number
    17
    34
    29
    10
    Inner ear disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    3
    1
    Meniere's disease
         subjects affected / exposed
    4 / 2014 (0.20%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    5
    3
    2
    Motion sickness
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neurosensory hypoacusis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    1
    1
    Presbyacusis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Tinnitus
         subjects affected / exposed
    10 / 2014 (0.50%)
    21 / 2014 (1.04%)
    15 / 2040 (0.74%)
    11 / 2040 (0.54%)
         occurrences all number
    10
    22
    17
    12
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    2
    1
    Vertigo
         subjects affected / exposed
    36 / 2014 (1.79%)
    66 / 2014 (3.28%)
    82 / 2040 (4.02%)
    41 / 2040 (2.01%)
         occurrences all number
    38
    78
    106
    50
    Vertigo positional
         subjects affected / exposed
    7 / 2014 (0.35%)
    10 / 2014 (0.50%)
    9 / 2040 (0.44%)
    4 / 2040 (0.20%)
         occurrences all number
    7
    10
    10
    5
    Vestibular ataxia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vestibular disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    2
    5
    2
    Amblyopia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Amaurosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anisometropia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Asthenopia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Anterior capsule contraction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Astigmatism
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Blepharitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    3
    2
    Blepharochalasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Blepharospasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cataract
         subjects affected / exposed
    32 / 2014 (1.59%)
    97 / 2014 (4.82%)
    105 / 2040 (5.15%)
    46 / 2040 (2.25%)
         occurrences all number
    38
    121
    128
    51
    Chalazion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    4
    2
    Cataract nuclear
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    12 / 2040 (0.59%)
    8 / 2040 (0.39%)
         occurrences all number
    4
    8
    12
    8
    Conjunctival oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    2
    2
    Conjunctival irritation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Corneal degeneration
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Conjunctivitis allergic
         subjects affected / exposed
    8 / 2014 (0.40%)
    12 / 2014 (0.60%)
    12 / 2040 (0.59%)
    5 / 2040 (0.25%)
         occurrences all number
    8
    12
    12
    5
    Corneal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Corneal erosion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Corneal opacity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Cystoid macular oedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diabetic retinopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dry eye
         subjects affected / exposed
    8 / 2014 (0.40%)
    15 / 2014 (0.74%)
    17 / 2040 (0.83%)
    8 / 2040 (0.39%)
         occurrences all number
    8
    15
    20
    8
    Diplopia
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    3
    1
    Eczema eyelids
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Endocrine ophthalmopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Episcleritis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Exfoliation glaucoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye allergy
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    1
    1
    Eye degenerative disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Eye inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Eye haemorrhage
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    2
    3
    1
    Eye irritation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    4
    1
    Eye pain
         subjects affected / exposed
    4 / 2014 (0.20%)
    11 / 2014 (0.55%)
    8 / 2040 (0.39%)
    3 / 2040 (0.15%)
         occurrences all number
    5
    15
    8
    3
    Eye pruritus
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    6
    3
    2
    Eye swelling
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Eye ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eyelid cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eyelid dermatochalasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Eyelid pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid ptosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Glaucoma
         subjects affected / exposed
    8 / 2014 (0.40%)
    24 / 2014 (1.19%)
    25 / 2040 (1.23%)
    14 / 2040 (0.69%)
         occurrences all number
    8
    25
    25
    14
    Hypermetropia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Iridocyclitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Iritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Keratitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    2
    1
    1
    Keratopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Lacrimal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lacrimal structural disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lacrimation decreased
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    2
    2
    Lacrimation increased
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    6
    5
    2
    Macular degeneration
         subjects affected / exposed
    1 / 2014 (0.05%)
    13 / 2014 (0.65%)
    10 / 2040 (0.49%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    13
    11
    3
    Macular fibrosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Macular hole
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Maculopathy
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Myopia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Narrow anterior chamber angle
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Ocular discomfort
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    2
    2
    Open angle glaucoma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Optic disc disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Periorbital oedema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Posterior capsule opacification
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    6
    0
    0
    Photopsia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Presbyopia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pterygium
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Refraction disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Retinal degeneration
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Retinal detachment
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    2
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Retinal vascular disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Retinal tear
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Retinal vascular occlusion
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Retinopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Strabismus
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Ulcerative keratitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Trichiasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Uveitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Vision blurred
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    11 / 2040 (0.54%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    5
    12
    5
    Visual acuity reduced
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    8
    3
    0
    Visual impairment
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    9 / 2040 (0.44%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    4
    9
    3
    Vitreous adhesions
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitreous degeneration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Vitreous disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitreous floaters
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    6
    3
    Xerophthalmia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    9 / 2014 (0.45%)
    15 / 2014 (0.74%)
    13 / 2040 (0.64%)
    7 / 2040 (0.34%)
         occurrences all number
    11
    17
    14
    8
    Abdominal adhesions
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    15 / 2014 (0.74%)
    23 / 2014 (1.14%)
    17 / 2040 (0.83%)
    8 / 2040 (0.39%)
         occurrences all number
    15
    24
    18
    8
    Abdominal hernia
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    6
    1
    0
    Abdominal mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    42 / 2014 (2.09%)
    84 / 2014 (4.17%)
    66 / 2040 (3.24%)
    38 / 2040 (1.86%)
         occurrences all number
    47
    98
    74
    40
    Abdominal pain lower
         subjects affected / exposed
    8 / 2014 (0.40%)
    14 / 2014 (0.70%)
    12 / 2040 (0.59%)
    9 / 2040 (0.44%)
         occurrences all number
    8
    17
    12
    9
    Abdominal pain upper
         subjects affected / exposed
    63 / 2014 (3.13%)
    109 / 2014 (5.41%)
    101 / 2040 (4.95%)
    62 / 2040 (3.04%)
         occurrences all number
    72
    129
    121
    63
    Abdominal rigidity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Abdominal symptom
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Acid peptic disease
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Anal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Anal incontinence
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    3
    1
    Anal prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anal pruritus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Anal sphincter atony
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anal ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anorectal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Anorectal varices
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    10 / 2040 (0.49%)
    6 / 2040 (0.29%)
         occurrences all number
    3
    3
    12
    7
    Apical granuloma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Aptyalism
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Breath odour
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Change of bowel habit
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    5
    2
    1
    Cheilitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Chronic gastritis
         subjects affected / exposed
    15 / 2014 (0.74%)
    30 / 2014 (1.49%)
    20 / 2040 (0.98%)
    9 / 2040 (0.44%)
         occurrences all number
    15
    30
    21
    9
    Coeliac disease
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Colitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    5
    2
    Colitis erosive
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Colitis psychogenic
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Colitis ischaemic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Colitis ulcerative
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Constipation
         subjects affected / exposed
    92 / 2014 (4.57%)
    133 / 2014 (6.60%)
    120 / 2040 (5.88%)
    75 / 2040 (3.68%)
         occurrences all number
    99
    155
    133
    79
    Dental caries
         subjects affected / exposed
    11 / 2014 (0.55%)
    33 / 2014 (1.64%)
    27 / 2040 (1.32%)
    10 / 2040 (0.49%)
         occurrences all number
    12
    42
    32
    11
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    93 / 2014 (4.62%)
    168 / 2014 (8.34%)
    165 / 2040 (8.09%)
    99 / 2040 (4.85%)
         occurrences all number
    119
    236
    204
    111
    Diverticulum
         subjects affected / exposed
    0 / 2014 (0.00%)
    5 / 2014 (0.25%)
    7 / 2040 (0.34%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    5
    7
    1
    Diverticulum intestinal
         subjects affected / exposed
    8 / 2014 (0.40%)
    19 / 2014 (0.94%)
    19 / 2040 (0.93%)
    7 / 2040 (0.34%)
         occurrences all number
    8
    19
    21
    8
    Dry mouth
         subjects affected / exposed
    7 / 2014 (0.35%)
    13 / 2014 (0.65%)
    14 / 2040 (0.69%)
    9 / 2040 (0.44%)
         occurrences all number
    7
    13
    14
    9
    Duodenal polyp
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Duodenitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    5
    3
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    4
    1
    1
    Duodenogastric reflux
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Dyspepsia
         subjects affected / exposed
    50 / 2014 (2.48%)
    82 / 2014 (4.07%)
    92 / 2040 (4.51%)
    52 / 2040 (2.55%)
         occurrences all number
    53
    98
    103
    56
    Dysphagia
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    9 / 2040 (0.44%)
    8 / 2040 (0.39%)
         occurrences all number
    1
    6
    9
    8
    Enteritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Enterocolitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Epigastric discomfort
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    8
    6
    3
    Erosive oesophagitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    2
    0
    Erosive duodenitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Eructation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    3
    2
    Faeces discoloured
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Food poisoning
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    7
    6
    3
    Flatulence
         subjects affected / exposed
    14 / 2014 (0.70%)
    16 / 2014 (0.79%)
    13 / 2040 (0.64%)
    6 / 2040 (0.29%)
         occurrences all number
    15
    19
    13
    6
    Frequent bowel movements
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastric disorder
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    6
    4
    2
    Gastric antral vascular ectasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastric mucosa erythema
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    2
    Gastric mucosal hypertrophy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastric polyps
         subjects affected / exposed
    4 / 2014 (0.20%)
    10 / 2014 (0.50%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    10
    1
    1
    Gastric ulcer
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    9 / 2040 (0.44%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    8
    10
    3
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastritis
         subjects affected / exposed
    59 / 2014 (2.93%)
    101 / 2014 (5.01%)
    92 / 2040 (4.51%)
    53 / 2040 (2.60%)
         occurrences all number
    67
    123
    118
    60
    Gastritis erosive
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    5
    6
    2
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Gastroduodenal ulcer
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Gastroduodenitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Gastrointestinal angiectasia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    6 / 2014 (0.30%)
    10 / 2014 (0.50%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    6
    12
    2
    0
    Gastrointestinal fistula
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    4
    2
    Gastrointestinal hypermotility
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal mucosal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal tract irritation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastrointestinal wall thickening
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    36 / 2014 (1.79%)
    58 / 2014 (2.88%)
    64 / 2040 (3.14%)
    29 / 2040 (1.42%)
         occurrences all number
    39
    65
    72
    29
    Gingival atrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrooesophageal sphincter insufficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Gingival disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gingival erythema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gingival hypertrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gingival pain
         subjects affected / exposed
    9 / 2014 (0.45%)
    14 / 2014 (0.70%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    9
    15
    6
    3
    Gingival recession
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gingival swelling
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    3
    2
    Glossitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Haematemesis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Haematochezia
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    6 / 2040 (0.29%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    4
    6
    1
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    5 / 2040 (0.25%)
         occurrences all number
    1
    2
    5
    5
    Haemorrhoids
         subjects affected / exposed
    19 / 2014 (0.94%)
    37 / 2014 (1.84%)
    32 / 2040 (1.57%)
    14 / 2040 (0.69%)
         occurrences all number
    19
    41
    32
    14
    Hernial eventration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hiatus hernia
         subjects affected / exposed
    15 / 2014 (0.74%)
    30 / 2014 (1.49%)
    24 / 2040 (1.18%)
    11 / 2040 (0.54%)
         occurrences all number
    15
    31
    24
    11
    Hyperchlorhydria
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Hypoaesthesia teeth
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ileus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Inguinal hernia
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    8
    1
    1
    Intestinal metaplasia
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Intestinal polyp
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    15 / 2014 (0.74%)
    32 / 2014 (1.59%)
    17 / 2040 (0.83%)
    10 / 2040 (0.49%)
         occurrences all number
    20
    42
    20
    11
    Large intestinal stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Large intestine polyp
         subjects affected / exposed
    7 / 2014 (0.35%)
    14 / 2014 (0.70%)
    16 / 2040 (0.78%)
    5 / 2040 (0.25%)
         occurrences all number
    7
    14
    16
    5
    Lip discolouration
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lip haematoma
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Lip swelling
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Loose tooth
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences all number
    2
    6
    8
    5
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    4
    4
    1
    0
    Malabsorption
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Melaena
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Mouth swelling
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    2
    5
    3
    Nausea
         subjects affected / exposed
    32 / 2014 (1.59%)
    47 / 2014 (2.33%)
    63 / 2040 (3.09%)
    38 / 2040 (1.86%)
         occurrences all number
    33
    53
    80
    45
    Noninfective gingivitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Noninfective sialoadenitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Obstruction gastric
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Odynophagia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Oesophageal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oesophageal polyp
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Oesophagitis
         subjects affected / exposed
    7 / 2014 (0.35%)
    8 / 2014 (0.40%)
    6 / 2040 (0.29%)
    2 / 2040 (0.10%)
         occurrences all number
    7
    8
    7
    2
    Oral contusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral discomfort
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Oral disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Oral mucosal discolouration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pancreatic cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Pancreatic disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pancreatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Pancreatitis chronic
         subjects affected / exposed
    4 / 2014 (0.20%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    4
    4
    0
    0
    Peptic ulcer
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    7
    3
    0
    Periodontal disease
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Periodontal inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Peritoneal adhesions
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presbyoesophagus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Proctitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    5
    7
    2
    Rectal polyp
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Rectal prolapse
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Reflux gastritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Salivary gland calculus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Salivary gland enlargement
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Salivary gland mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sensitivity of teeth
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Short-bowel syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    3
    1
    Swollen tongue
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tongue coated
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Tongue discolouration
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tongue discomfort
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Tongue disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Tongue ulceration
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tooth discolouration
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Tooth disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    5
    2
    Tooth impacted
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    2
    2
    Tooth loss
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    5
    4
    3
    Toothache
         subjects affected / exposed
    15 / 2014 (0.74%)
    32 / 2014 (1.59%)
    25 / 2040 (1.23%)
    10 / 2040 (0.49%)
         occurrences all number
    16
    39
    30
    11
    Umbilical hernia
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    5
    6
    3
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Varices oesophageal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Varicose veins of abdominal wall
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    26 / 2014 (1.29%)
    41 / 2014 (2.04%)
    44 / 2040 (2.16%)
    23 / 2040 (1.13%)
         occurrences all number
    34
    52
    53
    28
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Actinic keratosis
         subjects affected / exposed
    5 / 2014 (0.25%)
    9 / 2014 (0.45%)
    9 / 2040 (0.44%)
    3 / 2040 (0.15%)
         occurrences all number
    5
    10
    14
    3
    Alopecia
         subjects affected / exposed
    18 / 2014 (0.89%)
    24 / 2014 (1.19%)
    29 / 2040 (1.42%)
    18 / 2040 (0.88%)
         occurrences all number
    18
    25
    31
    18
    Alopecia areata
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Angioedema
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    3
    2
    Blister
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    1
    1
    Decubitus ulcer
         subjects affected / exposed
    1 / 2014 (0.05%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    6
    3
    2
    Dermal cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    0
    1
    7
    3
    Dermatitis
         subjects affected / exposed
    12 / 2014 (0.60%)
    25 / 2014 (1.24%)
    28 / 2040 (1.37%)
    17 / 2040 (0.83%)
         occurrences all number
    15
    32
    29
    18
    Dermatitis acneiform
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Dermatitis allergic
         subjects affected / exposed
    15 / 2014 (0.74%)
    28 / 2014 (1.39%)
    22 / 2040 (1.08%)
    12 / 2040 (0.59%)
         occurrences all number
    15
    30
    33
    16
    Dermatitis atopic
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Dermatitis contact
         subjects affected / exposed
    8 / 2014 (0.40%)
    10 / 2014 (0.50%)
    7 / 2040 (0.34%)
    4 / 2040 (0.20%)
         occurrences all number
    8
    10
    7
    4
    Dermatitis diaper
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Dermatitis psoriasiform
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Diabetic foot
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Drug eruption
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    4
    4
    3
    Dry skin
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    7 / 2040 (0.34%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    5
    7
    4
    Ecchymosis
         subjects affected / exposed
    10 / 2014 (0.50%)
    24 / 2014 (1.19%)
    14 / 2040 (0.69%)
    9 / 2040 (0.44%)
         occurrences all number
    11
    33
    15
    9
    Eczema
         subjects affected / exposed
    13 / 2014 (0.65%)
    17 / 2014 (0.84%)
    20 / 2040 (0.98%)
    8 / 2040 (0.39%)
         occurrences all number
    14
    22
    28
    10
    Eczema nummular
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    3 / 2014 (0.15%)
    8 / 2014 (0.40%)
    6 / 2040 (0.29%)
    5 / 2040 (0.25%)
         occurrences all number
    3
    9
    7
    6
    Generalised erythema
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hair growth abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hair texture abnormal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hand dermatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    8 / 2014 (0.40%)
    10 / 2014 (0.50%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    9
    12
    6
    3
    Hyperkeratosis
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    6
    5
    1
    Hypertrichosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hypertrophic scar
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    3
    5
    3
    Lichen sclerosus
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intertrigo
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    3
    2
    Lichen planus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Melanosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Macule
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    4
    1
    1
    Lichenoid keratosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Nail discomfort
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nail atrophy
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nail psoriasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail ridging
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail disorder
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Onychoclasis
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    5
    1
    1
    Night sweats
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    2
    6
    4
    Neurodermatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Onychomadesis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Onycholysis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Pain of skin
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Panniculitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Papule
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Pemphigus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Pemphigoid
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Prurigo
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Petechiae
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Pruritus
         subjects affected / exposed
    23 / 2014 (1.14%)
    43 / 2014 (2.14%)
    31 / 2040 (1.52%)
    12 / 2040 (0.59%)
         occurrences all number
    24
    52
    34
    14
    Pruritus allergic
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    5
    5
    4
    Pruritus generalised
         subjects affected / exposed
    15 / 2014 (0.74%)
    20 / 2014 (0.99%)
    18 / 2040 (0.88%)
    10 / 2040 (0.49%)
         occurrences all number
    17
    23
    18
    10
    Psoriasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    4
    5
    3
    Rash
         subjects affected / exposed
    22 / 2014 (1.09%)
    39 / 2014 (1.94%)
    36 / 2040 (1.76%)
    22 / 2040 (1.08%)
         occurrences all number
    25
    44
    41
    25
    Rash erythematous
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rash generalised
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    4
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Rash macular
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    3
    1
    1
    Rash papular
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    2
    2
    Rash papulosquamous
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    7 / 2014 (0.35%)
    9 / 2014 (0.45%)
    16 / 2040 (0.78%)
    13 / 2040 (0.64%)
         occurrences all number
    8
    10
    18
    15
    Rash vesicular
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rosacea
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    2
    5
    2
    Seborrhoea
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    2
    2
    Skin atrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin burning sensation
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Skin discolouration
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    4
    4
    2
    Skin disorder
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    6
    5
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Skin fissures
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Skin hypopigmentation
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    3
    1
    1
    Skin induration
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Skin mass
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    4
    3
    2
    Skin lesion
         subjects affected / exposed
    3 / 2014 (0.15%)
    10 / 2014 (0.50%)
    13 / 2040 (0.64%)
    10 / 2040 (0.49%)
         occurrences all number
    3
    11
    15
    12
    Skin necrosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Skin plaque
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Skin ulcer
         subjects affected / exposed
    6 / 2014 (0.30%)
    15 / 2014 (0.74%)
    17 / 2040 (0.83%)
    10 / 2040 (0.49%)
         occurrences all number
    6
    15
    18
    11
    Skin ulcer haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Solar dermatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Solar lentigo
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Stasis dermatitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Swelling face
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    1
    Telangiectasia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Toxic skin eruption
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Umbilical discharge
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    5 / 2014 (0.25%)
    6 / 2014 (0.30%)
    14 / 2040 (0.69%)
    5 / 2040 (0.25%)
         occurrences all number
    5
    6
    14
    5
    Urticaria chronic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vascular purpura
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Xeroderma
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    7
    3
    1
    Bladder dysfunction
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bladder pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Bladder prolapse
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Bladder perforation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Calculus urinary
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    4
    2
    Bladder spasm
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Costovertebral angle tenderness
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    7 / 2014 (0.35%)
    28 / 2014 (1.39%)
    21 / 2040 (1.03%)
    6 / 2040 (0.29%)
         occurrences all number
    7
    30
    22
    6
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Cystitis noninfective
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysuria
         subjects affected / exposed
    11 / 2014 (0.55%)
    19 / 2014 (0.94%)
    23 / 2040 (1.13%)
    14 / 2040 (0.69%)
         occurrences all number
    15
    26
    25
    14
    Haematuria
         subjects affected / exposed
    5 / 2014 (0.25%)
    13 / 2014 (0.65%)
    12 / 2040 (0.59%)
    7 / 2040 (0.34%)
         occurrences all number
    6
    14
    15
    8
    Hydronephrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Hydroureter
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertonic bladder
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Incontinence
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Kidney enlargement
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Leukocyturia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Kidney fibrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Nephritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Nephroangiosclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    8 / 2014 (0.40%)
    19 / 2014 (0.94%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    8
    19
    5
    2
    Nephropathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    3
    4
    3
    Nephroptosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Nephrosclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nocturia
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    5
    1
    Oliguria
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Pollakiuria
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    7 / 2040 (0.34%)
    4 / 2040 (0.20%)
         occurrences all number
    4
    8
    7
    4
    Polyuria
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    6 / 2040 (0.29%)
    5 / 2040 (0.25%)
         occurrences all number
    0
    0
    6
    5
    Proteinuria
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    4
    2
    Pyelocaliectasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Renal atrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal colic
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    5
    2
    Renal cyst
         subjects affected / exposed
    11 / 2014 (0.55%)
    29 / 2014 (1.44%)
    34 / 2040 (1.67%)
    13 / 2040 (0.64%)
         occurrences all number
    11
    30
    36
    14
    Renal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Renal failure
         subjects affected / exposed
    6 / 2014 (0.30%)
    8 / 2014 (0.40%)
    11 / 2040 (0.54%)
    4 / 2040 (0.20%)
         occurrences all number
    6
    9
    14
    5
    Renal impairment
         subjects affected / exposed
    5 / 2014 (0.25%)
    9 / 2014 (0.45%)
    11 / 2040 (0.54%)
    7 / 2040 (0.34%)
         occurrences all number
    5
    11
    13
    7
    Renal injury
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal pain
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    3
    3
    2
    Renal vein thrombosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Stress urinary incontinence
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Ureteric dilatation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urge incontinence
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    13 / 2014 (0.65%)
    28 / 2014 (1.39%)
    21 / 2040 (1.03%)
    9 / 2040 (0.44%)
         occurrences all number
    13
    28
    21
    9
    Urinary retention
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    1
    Urinary tract disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Urinary tract inflammation
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Urine abnormality
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Urine odour abnormal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Endocrine disorders
    Adrenal disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Adrenal insufficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Adrenal mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Empty sella syndrome
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    5
    2
    Goitre
         subjects affected / exposed
    10 / 2014 (0.50%)
    22 / 2014 (1.09%)
    21 / 2040 (1.03%)
    9 / 2040 (0.44%)
         occurrences all number
    10
    22
    21
    9
    Hypercorticoidism
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Hyperparathyroidism primary
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hyperthyroidism
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    20 / 2040 (0.98%)
    11 / 2040 (0.54%)
         occurrences all number
    5
    10
    23
    12
    Hypothyroidism
         subjects affected / exposed
    13 / 2014 (0.65%)
    35 / 2014 (1.74%)
    45 / 2040 (2.21%)
    18 / 2040 (0.88%)
         occurrences all number
    13
    37
    46
    18
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Thyroid cyst
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Thyroid disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Thyroid mass
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    6
    4
    1
    Thyroiditis chronic
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Toxic goitre
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Toxic nodular goitre
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    193 / 2014 (9.58%)
    380 / 2014 (18.87%)
    343 / 2040 (16.81%)
    165 / 2040 (8.09%)
         occurrences all number
    225
    574
    473
    198
    Arthritis
         subjects affected / exposed
    4 / 2014 (0.20%)
    12 / 2014 (0.60%)
    12 / 2040 (0.59%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    12
    14
    3
    Arthritis reactive
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Arthropathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    5
    1
    0
    Autoimmune arthritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    1
    0
    Axillary mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Back pain
         subjects affected / exposed
    221 / 2014 (10.97%)
    395 / 2014 (19.61%)
    330 / 2040 (16.18%)
    184 / 2040 (9.02%)
         occurrences all number
    259
    547
    427
    205
    Bone cyst
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    4
    2
    Bone deformity
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bone disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Bone loss
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Bone lesion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Bone swelling
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bone pain
         subjects affected / exposed
    28 / 2014 (1.39%)
    37 / 2014 (1.84%)
    20 / 2040 (0.98%)
    11 / 2040 (0.54%)
         occurrences all number
    31
    42
    23
    12
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Bursitis
         subjects affected / exposed
    12 / 2014 (0.60%)
    19 / 2014 (0.94%)
    13 / 2040 (0.64%)
    6 / 2040 (0.29%)
         occurrences all number
    13
    22
    14
    7
    Chondrocalcinosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Coccydynia
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    7
    3
    0
    Costochondritis
         subjects affected / exposed
    5 / 2014 (0.25%)
    10 / 2014 (0.50%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    5
    11
    5
    4
    Deformity thorax
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Dupuytren's contracture
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Enostosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Enthesopathy
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Exostosis
         subjects affected / exposed
    7 / 2014 (0.35%)
    16 / 2014 (0.79%)
    12 / 2040 (0.59%)
    2 / 2040 (0.10%)
         occurrences all number
    9
    19
    12
    2
    Femoroacetabular impingement
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fibromyalgia
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    5
    4
    2
    Finger deformity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Flank pain
         subjects affected / exposed
    5 / 2014 (0.25%)
    7 / 2014 (0.35%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    5
    7
    4
    3
    Foot deformity
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    8
    5
    2
    Fracture pain
         subjects affected / exposed
    5 / 2014 (0.25%)
    8 / 2014 (0.40%)
    13 / 2040 (0.64%)
    11 / 2040 (0.54%)
         occurrences all number
    5
    8
    14
    12
    Gouty arthritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Groin pain
         subjects affected / exposed
    11 / 2014 (0.55%)
    18 / 2014 (0.89%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    11
    18
    6
    4
    Haemarthrosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hand deformity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypercreatinaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Interspinous osteoarthritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    7 / 2040 (0.34%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    8
    7
    4
    Intervertebral disc disorder
         subjects affected / exposed
    7 / 2014 (0.35%)
    14 / 2014 (0.70%)
    26 / 2040 (1.27%)
    8 / 2040 (0.39%)
         occurrences all number
    7
    14
    29
    8
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    8 / 2040 (0.39%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    5
    11
    4
    Intervertebral disc space narrowing
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    1
    Joint ankylosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Joint crepitation
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Joint effusion
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Joint instability
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint lock
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Joint range of motion decreased
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    6
    3
    0
    Joint stiffness
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    5
    2
    2
    Joint swelling
         subjects affected / exposed
    7 / 2014 (0.35%)
    19 / 2014 (0.94%)
    27 / 2040 (1.32%)
    11 / 2040 (0.54%)
         occurrences all number
    7
    20
    30
    12
    Kyphosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    3
    2
    Ligamentitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Limb deformity
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Limb discomfort
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    4
    3
    Loose body in joint
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lordosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    5
    2
    0
    Metatarsalgia
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    1
    1
    Mobility decreased
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    7
    4
    1
    Muscle atrophy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Muscle contracture
         subjects affected / exposed
    10 / 2014 (0.50%)
    14 / 2014 (0.70%)
    12 / 2040 (0.59%)
    7 / 2040 (0.34%)
         occurrences all number
    11
    16
    13
    8
    Muscle disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Muscle fatigue
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    1
    1
    Muscle spasms
         subjects affected / exposed
    81 / 2014 (4.02%)
    128 / 2014 (6.36%)
    121 / 2040 (5.93%)
    70 / 2040 (3.43%)
         occurrences all number
    87
    155
    136
    73
    Muscle tightness
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    1
    3
    3
    Muscle twitching
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    2
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    22 / 2014 (1.09%)
    50 / 2014 (2.48%)
    30 / 2040 (1.47%)
    14 / 2040 (0.69%)
         occurrences all number
    24
    56
    33
    14
    Muscular weakness
         subjects affected / exposed
    7 / 2014 (0.35%)
    16 / 2014 (0.79%)
    19 / 2040 (0.93%)
    14 / 2040 (0.69%)
         occurrences all number
    7
    18
    23
    16
    Musculoskeletal discomfort
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    4
    6
    3
    Musculoskeletal pain
         subjects affected / exposed
    83 / 2014 (4.12%)
    155 / 2014 (7.70%)
    145 / 2040 (7.11%)
    70 / 2040 (3.43%)
         occurrences all number
    95
    188
    171
    78
    Musculoskeletal stiffness
         subjects affected / exposed
    5 / 2014 (0.25%)
    7 / 2014 (0.35%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences all number
    5
    7
    9
    5
    Myalgia
         subjects affected / exposed
    55 / 2014 (2.73%)
    76 / 2014 (3.77%)
    82 / 2040 (4.02%)
    56 / 2040 (2.75%)
         occurrences all number
    59
    89
    90
    58
    Myofascial pain syndrome
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    6
    2
    2
    Myositis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Neck deformity
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Neck pain
         subjects affected / exposed
    42 / 2014 (2.09%)
    75 / 2014 (3.72%)
    59 / 2040 (2.89%)
    34 / 2040 (1.67%)
         occurrences all number
    46
    90
    66
    34
    Neck mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Osteolysis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    111 / 2014 (5.51%)
    206 / 2014 (10.23%)
    189 / 2040 (9.26%)
    113 / 2040 (5.54%)
         occurrences all number
    131
    279
    243
    131
    Osteochondrosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    5
    1
    Osteoporosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    1
    4
    2
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Osteosclerosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    2
    2
    Pain in extremity
         subjects affected / exposed
    129 / 2014 (6.41%)
    253 / 2014 (12.56%)
    230 / 2040 (11.27%)
    121 / 2040 (5.93%)
         occurrences all number
    150
    350
    308
    138
    Pain in jaw
         subjects affected / exposed
    4 / 2014 (0.20%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    5
    5
    4
    1
    Periarthritis
         subjects affected / exposed
    6 / 2014 (0.30%)
    16 / 2014 (0.79%)
    9 / 2040 (0.44%)
    7 / 2040 (0.34%)
         occurrences all number
    6
    17
    10
    8
    Polyarthritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Plantar fasciitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    8 / 2014 (0.40%)
    8 / 2040 (0.39%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    9
    9
    3
    Periostitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Polymyalgia rheumatica
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    5
    5
    1
    Rheumatoid arthritis
         subjects affected / exposed
    6 / 2014 (0.30%)
    10 / 2014 (0.50%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences all number
    8
    20
    12
    6
    Sacroiliitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    7 / 2014 (0.35%)
    12 / 2014 (0.60%)
    10 / 2040 (0.49%)
    5 / 2040 (0.25%)
         occurrences all number
    7
    12
    12
    7
    Scoliosis
         subjects affected / exposed
    4 / 2014 (0.20%)
    13 / 2014 (0.65%)
    12 / 2040 (0.59%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    14
    12
    2
    Seronegative arthritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Sjogren's syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Soft tissue disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Spinal column stenosis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Soft tissue mass
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Spinal osteoarthritis
         subjects affected / exposed
    26 / 2014 (1.29%)
    52 / 2014 (2.58%)
    50 / 2040 (2.45%)
    23 / 2040 (1.13%)
         occurrences all number
    29
    58
    52
    23
    Spinal disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spinal deformity
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    3
    1
    Spondylitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    4
    2
    Spondyloarthropathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Spinal pain
         subjects affected / exposed
    14 / 2014 (0.70%)
    44 / 2014 (2.18%)
    58 / 2040 (2.84%)
    29 / 2040 (1.42%)
         occurrences all number
    16
    52
    67
    30
    Spondylolisthesis
         subjects affected / exposed
    5 / 2014 (0.25%)
    12 / 2014 (0.60%)
    9 / 2040 (0.44%)
    5 / 2040 (0.25%)
         occurrences all number
    6
    13
    9
    5
    Spondylolysis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sympathetic posterior cervical syndrome
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Synovial cyst
         subjects affected / exposed
    4 / 2014 (0.20%)
    8 / 2014 (0.40%)
    9 / 2040 (0.44%)
    4 / 2040 (0.20%)
         occurrences all number
    4
    8
    9
    4
    Synovitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Temporomandibular joint syndrome
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    3
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Tendon disorder
         subjects affected / exposed
    4 / 2014 (0.20%)
    5 / 2014 (0.25%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    5
    6
    5
    Tendon pain
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Tendonitis
         subjects affected / exposed
    17 / 2014 (0.84%)
    34 / 2014 (1.69%)
    20 / 2040 (0.98%)
    13 / 2040 (0.64%)
         occurrences all number
    17
    36
    24
    16
    Tenosynovitis stenosans
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    2
    1
    1
    Tenosynovitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    1
    1
    Trismus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Torticollis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    2
    1
    Trigger finger
         subjects affected / exposed
    10 / 2014 (0.50%)
    15 / 2014 (0.74%)
    13 / 2040 (0.64%)
    8 / 2040 (0.39%)
         occurrences all number
    10
    16
    14
    8
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Vertebral wedging
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Abscess limb
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    3
    1
    Abscess oral
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    1
    1
    Acute sinusitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    6
    6
    3
    Amoebic dysentery
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Appendiceal abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Appendicitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Arthritis bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Arthritis infective
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asymptomatic bacteriuria
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    7
    5
    0
    Atypical pneumonia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Bacterial diarrhoea
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    1
    1
    Bacterial infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    3
    1
    Bacterial tracheitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Bacterial vaginosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Bacterial vulvovaginitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bacteriuria
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Bartholin's abscess
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Body tinea
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    3
    1
    0
    Borrelia infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Breast abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchiolitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    100 / 2014 (4.97%)
    187 / 2014 (9.29%)
    176 / 2040 (8.63%)
    88 / 2040 (4.31%)
         occurrences all number
    110
    242
    236
    97
    Bronchitis bacterial
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    9 / 2040 (0.44%)
    6 / 2040 (0.29%)
         occurrences all number
    4
    7
    12
    7
    Bronchitis viral
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    1
    1
    Candida infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Carbuncle
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    11 / 2014 (0.55%)
    24 / 2014 (1.19%)
    21 / 2040 (1.03%)
    12 / 2040 (0.59%)
         occurrences all number
    12
    27
    26
    14
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cervicitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    3
    2
    Chikungunya virus infection
         subjects affected / exposed
    2 / 2014 (0.10%)
    7 / 2014 (0.35%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    7
    4
    2
    Chronic sinusitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    3
    1
    Chronic tonsillitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    16 / 2014 (0.79%)
    36 / 2014 (1.79%)
    31 / 2040 (1.52%)
    14 / 2040 (0.69%)
         occurrences all number
    16
    37
    33
    14
    Conjunctivitis bacterial
         subjects affected / exposed
    10 / 2014 (0.50%)
    14 / 2014 (0.70%)
    11 / 2040 (0.54%)
    8 / 2040 (0.39%)
         occurrences all number
    10
    14
    13
    8
    Conjunctivitis viral
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Corneal infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cystitis
         subjects affected / exposed
    27 / 2014 (1.34%)
    49 / 2014 (2.43%)
    39 / 2040 (1.91%)
    25 / 2040 (1.23%)
         occurrences all number
    35
    64
    57
    31
    Cystitis bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    2
    2
    Dacryocanaliculitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dacryocystitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Dengue fever
         subjects affected / exposed
    2 / 2014 (0.10%)
    10 / 2014 (0.50%)
    5 / 2040 (0.25%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    11
    5
    1
    Dermatitis infected
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Dermatophytosis of nail
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    2
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Diverticulitis
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    7 / 2040 (0.34%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    6
    7
    2
    Ear infection
         subjects affected / exposed
    5 / 2014 (0.25%)
    12 / 2014 (0.60%)
    5 / 2040 (0.25%)
    0 / 2040 (0.00%)
         occurrences all number
    5
    12
    5
    0
    Ear infection bacterial
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    3
    2
    Ear infection fungal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    5
    2
    Ear infection viral
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Enterobiasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Enterococcal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Enterocolitis viral
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Erysipelas
         subjects affected / exposed
    3 / 2014 (0.15%)
    13 / 2014 (0.65%)
    7 / 2040 (0.34%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    14
    9
    4
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    3
    2
    Eye infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    2
    0
    Eye infection bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Eyelid infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Flavivirus infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Febrile infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Fungal infection
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    5
    2
    1
    Fungal skin infection
         subjects affected / exposed
    6 / 2014 (0.30%)
    7 / 2014 (0.35%)
    14 / 2040 (0.69%)
    7 / 2040 (0.34%)
         occurrences all number
    6
    7
    15
    7
    Folliculitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    2
    2
    Furuncle
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    8 / 2040 (0.39%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    6
    8
    4
    Gastritis bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    1
    Gastroenteritis
         subjects affected / exposed
    41 / 2014 (2.04%)
    73 / 2014 (3.62%)
    64 / 2040 (3.14%)
    36 / 2040 (1.76%)
         occurrences all number
    42
    82
    73
    38
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    15 / 2014 (0.74%)
    25 / 2014 (1.24%)
    27 / 2040 (1.32%)
    12 / 2040 (0.59%)
         occurrences all number
    16
    27
    29
    12
    Gastrointestinal bacterial infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    1
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    9 / 2014 (0.45%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    9
    5
    4
    Genital candidiasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Genital herpes
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    3
    3
    Genital herpes zoster
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Genital infection fungal
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Genitourinary tract infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Gingival abscess
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    4
    3
    0
    Giardiasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    2
    1
    1
    Gingivitis
         subjects affected / exposed
    11 / 2014 (0.55%)
    18 / 2014 (0.89%)
    16 / 2040 (0.78%)
    8 / 2040 (0.39%)
         occurrences all number
    12
    21
    23
    10
    Groin infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    H1N1 influenza
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Helicobacter gastritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    5
    3
    1
    Helicobacter infection
         subjects affected / exposed
    5 / 2014 (0.25%)
    13 / 2014 (0.65%)
    10 / 2040 (0.49%)
    3 / 2040 (0.15%)
         occurrences all number
    5
    13
    11
    3
    Helminthic infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hepatitis B
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hepatic echinococciasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Hepatitis C
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Herpes dermatitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Herpes ophthalmic
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Herpes simplex
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    5
    2
    Herpes virus infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    4
    1
    1
    Herpes zoster
         subjects affected / exposed
    21 / 2014 (1.04%)
    45 / 2014 (2.23%)
    45 / 2040 (2.21%)
    14 / 2040 (0.69%)
         occurrences all number
    21
    46
    48
    15
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Herpes zoster infection neurological
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    1
    1
    Impetigo
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Implant site infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Incision site infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Infected bite
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    4
    2
    0
    Infected fistula
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infected skin ulcer
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    4
    4
    4
    Infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Infection parasitic
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    5
    2
    1
    Influenza
         subjects affected / exposed
    57 / 2014 (2.83%)
    119 / 2014 (5.91%)
    105 / 2040 (5.15%)
    49 / 2040 (2.40%)
         occurrences all number
    68
    155
    128
    51
    Injection site infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Kidney infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Labyrinthitis
         subjects affected / exposed
    8 / 2014 (0.40%)
    12 / 2014 (0.60%)
    10 / 2040 (0.49%)
    6 / 2040 (0.29%)
         occurrences all number
    8
    13
    10
    6
    Laryngitis
         subjects affected / exposed
    4 / 2014 (0.20%)
    15 / 2014 (0.74%)
    16 / 2040 (0.78%)
    7 / 2040 (0.34%)
         occurrences all number
    4
    16
    18
    8
    Laryngitis bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    0
    2
    2
    Laryngitis viral
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Latent syphilis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lip infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Localised infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    7 / 2040 (0.34%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    3
    7
    2
    Lower respiratory tract infection
         subjects affected / exposed
    9 / 2014 (0.45%)
    17 / 2014 (0.84%)
    24 / 2040 (1.18%)
    11 / 2040 (0.54%)
         occurrences all number
    13
    31
    44
    16
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Lyme disease
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Lymphadenitis bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lymphangitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mycobacterium abscessus infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail bed infection bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    43 / 2014 (2.14%)
    70 / 2014 (3.48%)
    72 / 2040 (3.53%)
    41 / 2040 (2.01%)
         occurrences all number
    50
    87
    88
    51
    Nail infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    2
    1
    Onychomycosis
         subjects affected / exposed
    7 / 2014 (0.35%)
    18 / 2014 (0.89%)
    18 / 2040 (0.88%)
    10 / 2040 (0.49%)
         occurrences all number
    7
    18
    19
    10
    Oophoritis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Oral candidiasis
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    8 / 2040 (0.39%)
    5 / 2040 (0.25%)
         occurrences all number
    4
    7
    9
    5
    Oral bacterial infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral fungal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    0
    0
    6
    4
    Oral herpes
         subjects affected / exposed
    7 / 2014 (0.35%)
    11 / 2014 (0.55%)
    15 / 2040 (0.74%)
    9 / 2040 (0.44%)
         occurrences all number
    8
    15
    18
    9
    Oral infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral viral infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteomyelitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Otitis externa
         subjects affected / exposed
    5 / 2014 (0.25%)
    7 / 2014 (0.35%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    7
    10
    6
    4
    Otitis externa bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Otitis media
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    6
    6
    2
    Otitis media acute
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Otitis media chronic
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Otitis media bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Parasitic gastroenteritis
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    4
    3
    2
    Paronychia
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    1
    4
    5
    4
    Parotitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Periodontitis
         subjects affected / exposed
    6 / 2014 (0.30%)
    9 / 2014 (0.45%)
    14 / 2040 (0.69%)
    10 / 2040 (0.49%)
         occurrences all number
    6
    10
    15
    11
    Peritonitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Peritonsillar abscess
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    36 / 2014 (1.79%)
    50 / 2014 (2.48%)
    57 / 2040 (2.79%)
    29 / 2040 (1.42%)
         occurrences all number
    39
    63
    63
    30
    Pharyngitis bacterial
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    11 / 2040 (0.54%)
    8 / 2040 (0.39%)
         occurrences all number
    3
    5
    12
    8
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    4
    5
    4
    Pneumonia
         subjects affected / exposed
    21 / 2014 (1.04%)
    53 / 2014 (2.63%)
    46 / 2040 (2.25%)
    19 / 2040 (0.93%)
         occurrences all number
    23
    58
    60
    22
    Pneumococcal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Pneumonia adenoviral
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    4 / 2014 (0.20%)
    9 / 2014 (0.45%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    4
    10
    3
    2
    Pneumonia escherichia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Post procedural infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Pulpitis dental
         subjects affected / exposed
    6 / 2014 (0.30%)
    10 / 2014 (0.50%)
    7 / 2040 (0.34%)
    2 / 2040 (0.10%)
         occurrences all number
    7
    11
    9
    3
    Pyelitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Pyelocystitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pyelonephritis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    5
    2
    0
    Pyelonephritis chronic
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    3
    2
    Pyometra
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash pustular
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    16 / 2014 (0.79%)
    39 / 2014 (1.94%)
    47 / 2040 (2.30%)
    20 / 2040 (0.98%)
         occurrences all number
    17
    45
    57
    22
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    10 / 2040 (0.49%)
    6 / 2040 (0.29%)
         occurrences all number
    3
    6
    13
    6
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Rhinitis
         subjects affected / exposed
    13 / 2014 (0.65%)
    20 / 2014 (0.99%)
    19 / 2040 (0.93%)
    14 / 2040 (0.69%)
         occurrences all number
    14
    22
    22
    17
    Root canal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Sepsis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Septic encephalopathy
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Septic shock
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Sialoadenitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Sinobronchitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    28 / 2014 (1.39%)
    50 / 2014 (2.48%)
    29 / 2040 (1.42%)
    11 / 2040 (0.54%)
         occurrences all number
    30
    61
    29
    11
    Sinusitis bacterial
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    2
    1
    Skin bacterial infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Skin candida
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Soft tissue infection
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    4
    7
    2
    1
    Skin infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    7 / 2014 (0.35%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    7
    4
    2
    Staphylococcal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    3
    4
    2
    1
    Tick-borne fever
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tinea capitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tinea pedis
         subjects affected / exposed
    2 / 2014 (0.10%)
    4 / 2014 (0.20%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    2
    5
    6
    3
    Tonsillitis
         subjects affected / exposed
    7 / 2014 (0.35%)
    13 / 2014 (0.65%)
    18 / 2040 (0.88%)
    7 / 2040 (0.34%)
         occurrences all number
    7
    13
    19
    7
    Tonsillitis bacterial
         subjects affected / exposed
    3 / 2014 (0.15%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Tooth abscess
         subjects affected / exposed
    6 / 2014 (0.30%)
    16 / 2014 (0.79%)
    13 / 2040 (0.64%)
    4 / 2040 (0.20%)
         occurrences all number
    6
    18
    15
    4
    Tooth infection
         subjects affected / exposed
    9 / 2014 (0.45%)
    14 / 2014 (0.70%)
    12 / 2040 (0.59%)
    6 / 2040 (0.29%)
         occurrences all number
    9
    14
    12
    6
    Tracheitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    2
    2
    1
    Tracheobronchitis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    1
    6
    3
    Tuberculosis
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Upper respiratory fungal infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    132 / 2014 (6.55%)
    226 / 2014 (11.22%)
    205 / 2040 (10.05%)
    130 / 2040 (6.37%)
         occurrences all number
    212
    481
    444
    187
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    1
    1
    4
    3
    Urethritis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    13 / 2014 (0.65%)
    17 / 2014 (0.84%)
    13 / 2040 (0.64%)
    8 / 2040 (0.39%)
         occurrences all number
    15
    20
    15
    9
    Urinary tract infection
         subjects affected / exposed
    128 / 2014 (6.36%)
    244 / 2014 (12.12%)
    180 / 2040 (8.82%)
    97 / 2040 (4.75%)
         occurrences all number
    151
    358
    231
    108
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Urinary tract infection fungal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    2
    Urinary tract infection staphylococcal
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vaginal abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    7
    5
    2
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    3
    4
    0
    0
    Viral diarrhoea
         subjects affected / exposed
    5 / 2014 (0.25%)
    10 / 2014 (0.50%)
    4 / 2040 (0.20%)
    4 / 2040 (0.20%)
         occurrences all number
    5
    10
    5
    5
    Viral infection
         subjects affected / exposed
    7 / 2014 (0.35%)
    14 / 2014 (0.70%)
    10 / 2040 (0.49%)
    3 / 2040 (0.15%)
         occurrences all number
    8
    17
    12
    3
    Viral rash
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral pharyngitis
         subjects affected / exposed
    3 / 2014 (0.15%)
    5 / 2014 (0.25%)
    5 / 2040 (0.25%)
    4 / 2040 (0.20%)
         occurrences all number
    3
    5
    5
    4
    Viral rhinitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    3
    1
    Viral skin infection
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    2
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    233 / 2014 (11.57%)
    406 / 2014 (20.16%)
    388 / 2040 (19.02%)
    217 / 2040 (10.64%)
         occurrences all number
    283
    697
    621
    268
    Vulval abscess
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vulvitis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    2
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    3 / 2014 (0.15%)
    4 / 2014 (0.20%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    5
    5
    3
    Vulvovaginitis
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    2 / 2040 (0.10%)
    2 / 2040 (0.10%)
         occurrences all number
    2
    2
    2
    2
    Wound infection
         subjects affected / exposed
    6 / 2014 (0.30%)
    11 / 2014 (0.55%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    7
    14
    3
    2
    Wound infection bacterial
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    4
    3
    2
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    4
    0
    Acquired mixed hyperlipidaemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    3 / 2014 (0.15%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Carbohydrate intolerance
         subjects affected / exposed
    4 / 2014 (0.20%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    4
    6
    4
    3
    Calcium metabolism disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Decreased appetite
         subjects affected / exposed
    19 / 2014 (0.94%)
    29 / 2014 (1.44%)
    35 / 2040 (1.72%)
    22 / 2040 (1.08%)
         occurrences all number
    19
    29
    40
    23
    Dehydration
         subjects affected / exposed
    2 / 2014 (0.10%)
    5 / 2014 (0.25%)
    10 / 2040 (0.49%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    5
    10
    4
    Diabetes mellitus
         subjects affected / exposed
    12 / 2014 (0.60%)
    27 / 2014 (1.34%)
    28 / 2040 (1.37%)
    14 / 2040 (0.69%)
         occurrences all number
    14
    29
    30
    15
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 2014 (0.05%)
    5 / 2014 (0.25%)
    7 / 2040 (0.34%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    5
    7
    1
    Dyslipidaemia
         subjects affected / exposed
    28 / 2014 (1.39%)
    64 / 2014 (3.18%)
    55 / 2040 (2.70%)
    23 / 2040 (1.13%)
         occurrences all number
    28
    64
    56
    23
    Fluid overload
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    1
    1
    Electrolyte imbalance
         subjects affected / exposed
    1 / 2014 (0.05%)
    3 / 2014 (0.15%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    3
    4
    1
    Fluid retention
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Folate deficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    1
    1
    Food intolerance
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    8 / 2014 (0.40%)
    11 / 2014 (0.55%)
    6 / 2040 (0.29%)
    3 / 2040 (0.15%)
         occurrences all number
    8
    11
    6
    3
    Gluten sensitivity
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gout
         subjects affected / exposed
    3 / 2014 (0.15%)
    7 / 2014 (0.35%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    3
    8
    4
    2
    Hyperammonaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    3 / 2040 (0.15%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    7
    3
    3
    Hypercholesterolaemia
         subjects affected / exposed
    16 / 2014 (0.79%)
    36 / 2014 (1.79%)
    46 / 2040 (2.25%)
    26 / 2040 (1.27%)
         occurrences all number
    16
    37
    46
    26
    Hyperhomocysteinaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    13 / 2014 (0.65%)
    20 / 2014 (0.99%)
    17 / 2040 (0.83%)
    11 / 2040 (0.54%)
         occurrences all number
    13
    22
    17
    11
    Hyperlipidaemia
         subjects affected / exposed
    6 / 2014 (0.30%)
    17 / 2014 (0.84%)
    18 / 2040 (0.88%)
    5 / 2040 (0.25%)
         occurrences all number
    6
    17
    19
    5
    Hyperkalaemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    6 / 2014 (0.30%)
    9 / 2040 (0.44%)
    4 / 2040 (0.20%)
         occurrences all number
    2
    7
    11
    4
    Hypermagnesaemia
         subjects affected / exposed
    4 / 2014 (0.20%)
    7 / 2014 (0.35%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    7
    10
    2
    1
    Hypernatraemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperphagia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    3 / 2014 (0.15%)
    9 / 2014 (0.45%)
    5 / 2040 (0.25%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    9
    5
    3
    Hyperuricaemia
         subjects affected / exposed
    4 / 2014 (0.20%)
    12 / 2014 (0.60%)
    18 / 2040 (0.88%)
    10 / 2040 (0.49%)
         occurrences all number
    4
    12
    20
    10
    Hyperphosphataemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 2014 (0.10%)
    2 / 2014 (0.10%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    2
    3
    3
    1
    Hypervitaminosis D
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypochloraemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    4 / 2040 (0.20%)
    2 / 2040 (0.10%)
         occurrences all number
    1
    2
    4
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    4 / 2040 (0.20%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    4
    1
    Hypoglycaemia
         subjects affected / exposed
    6 / 2014 (0.30%)
    14 / 2014 (0.70%)
    12 / 2040 (0.59%)
    6 / 2040 (0.29%)
         occurrences all number
    7
    16
    13
    7
    Hypomagnesaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    4 / 2014 (0.20%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    4
    2
    0
    Hypokalaemia
         subjects affected / exposed
    8 / 2014 (0.40%)
    20 / 2014 (0.99%)
    27 / 2040 (1.32%)
    14 / 2040 (0.69%)
         occurrences all number
    8
    21
    29
    14
    Hypophosphataemia
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    7 / 2014 (0.35%)
    26 / 2014 (1.29%)
    23 / 2040 (1.13%)
    11 / 2040 (0.54%)
         occurrences all number
    7
    26
    27
    14
    Hypoproteinaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypovitaminosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypovolaemia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    5 / 2014 (0.25%)
    8 / 2014 (0.40%)
    6 / 2040 (0.29%)
    4 / 2040 (0.20%)
         occurrences all number
    5
    8
    6
    4
    Increased appetite
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Iron deficiency
         subjects affected / exposed
    1 / 2014 (0.05%)
    4 / 2014 (0.20%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    4
    3
    1
    Lipid metabolism disorder
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 2014 (0.00%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Malnutrition
         subjects affected / exposed
    1 / 2014 (0.05%)
    1 / 2014 (0.05%)
    3 / 2040 (0.15%)
    1 / 2040 (0.05%)
         occurrences all number
    1
    1
    3
    1
    Metabolic disorder
         subjects affected / exposed
    1 / 2014 (0.05%)
    2 / 2014 (0.10%)
    0 / 2040 (0.00%)
    0 / 2040 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mineral deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    2 / 2040 (0.10%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Obesity
         subjects affected / exposed
    3 / 2014 (0.15%)
    6 / 2014 (0.30%)
    4 / 2040 (0.20%)
    3 / 2040 (0.15%)
         occurrences all number
    3
    6
    4
    3
    Polydipsia
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    9 / 2014 (0.45%)
    13 / 2014 (0.65%)
    16 / 2040 (0.78%)
    5 / 2040 (0.25%)
         occurrences all number
    9
    13
    16
    5
    Underweight
         subjects affected / exposed
    0 / 2014 (0.00%)
    0 / 2014 (0.00%)
    1 / 2040 (0.05%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    0
    1
    1
    Vitamin B complex deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    1 / 2014 (0.05%)
    2 / 2040 (0.10%)
    1 / 2040 (0.05%)
         occurrences all number
    0
    1
    2
    1
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    6 / 2014 (0.30%)
    5 / 2040 (0.25%)
    2 / 2040 (0.10%)
         occurrences all number
    0
    6
    5
    2
    Vitamin D deficiency
         subjects affected / exposed
    0 / 2014 (0.00%)
    3 / 2014 (0.15%)
    4 / 2040 (0.20%)
    0 / 2040 (0.00%)
         occurrences all number
    0
    3
    4
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2012
    - Subjects with a reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth were excluded from study participation. - A physician was to be available during administration of investigational product, and all subjects were closely observed for approximately 30 minutes after dosing with IP. - The investigator was to be alerted if a subject experienced a BMD loss from baseline of ≥ 7% at the total hip and/or at the lumbar spine at any time during the study, and was required to discuss implications for individual fracture risk, alternative treatment options, and options for continuing in the study with the subject.
    14 Nov 2012
    Following regulatory agency feedback, this amendment incorporated changes to facilitate optimal evaluation of the risk/benefit profile of romosozumab, to clarify statistical considerations, and to outline expectation for reporting of serious adverse events. Study procedures were simplified there was no impact on the evaluation of study objectives. - Amended exclusion criteria to ensure that pre-existing disorders and/or the administration of medications did not confound the risk/benefit assessment for romosozumab. - Amended proscribed treatments during the study to ensure those did not confound the risk/benefit assessment for romosozumab. - Provided more detail on the adjudication of possible events of osteonecrosis of the jaw, atypical femoral fractures, and cardiovascular events. Statistical considerations: - Clarified that worsening vertebral fractures were considered for endpoints evaluating the incidence of all fractures. - For endpoints evaluating the incidence of major osteoporotic fractures, corrected the definition to include forearm instead of wrist fractures. - Baseline total hip BMD T-score was aligned with the Statistical Analysis Plan as an adjustment factor for the evaluation of new vertebral fracture incidence. Serious adverse event reporting: - Specified that serious adverse events must be reported within 24 hours after the investigator¡¦s knowledge of the event and clarified the point of reference for evaluation of expectedness of serious adverse events. Changes to study procedures: - Clarified the day 1 lumbar spine DXA scan may have been taken together with the screening proximal femur DXA scan for subject convenience. - Replaced the month 21 clinic visit with a telephone call. - For subjects participating in the Imaging and PK/BTM /Biomarker Substudy, the spine QCT assessments at month 36 and the end-of-study visits were eliminated.
    21 Jun 2013
    The eligibility criteria were modified to allow participation of a wider range of subjects. Criteria revisions included the following: - Lowering the minimum age from 60 to 55 years and allowing 3 additional qualifying BMD and fracture history combinations. - The protocol-mandated off-treatment times for exclusionary medications were revised. - Rescreening was allowed for subjects who previously failed screening if in the opinion of the investigator the reason for the initial screen failure has resolved or was no longer applicable. - Based on regulatory agency feedback, assessments for formation of antiromosozumab antibodies were added at the month 1 and month 3 study visits to allow a more comprehensive characterization of the antibody response. - Retesting of serum calcium would be permitted within the screening window if the initial test indicated an elevated level of serum calcium within 1.1 x the upper limit of normal.
    08 Jul 2015
    The protocol was amended to include the addition of a Final Analysis. The study's previous primary analysis remained unchanged. - Upon completion of the primary analysis period, subjects were followed for nonvertebral fractures. Subjects and site personnel remained blinded to initial treatment assignments and the study proceeded in an event-driven manner. The final analysis (end-of-study) occurred when nonvertebral fracture events were confirmed for at least 440 subjects, or earlier if the primary analysis demonstrated superiority of romosozumab treatment for nonvertebral fracture risk reduction. The duration of participation for subjects was changed from 25 to 59 months if study completion was achieved at primary analysis, or from 37 to 71 months if study completion was achieved when 440 subjects experienced a nonvertebral fracture. - Approximately 200 subjects were planned to be enrolled in an Imaging and PK/BTM/Biomarker Substudy, with a subset of approximately 100 subjects participating in the imaging (DXA, QCT) portion of the substudy. - The exclusion criteria for hyper-/hypothyroidism and hyper-/hypoparathyroidism were clarified. - The month 15 study visit was eliminated for all but the substudy participants, and sampling for antibody testing was added to the month 18 visit. The end of primary analysis and end-of-study visits were replaced by telephone contact.
    14 Sep 2016
    - Moved the following month-12 exploratory endpoints to secondary endpoints: nonvertebral fracture, hip fracture, major osteoporotic fracture (hip, forearm, humerus, and clinical vertebral). - Added clinical vertebral fracture as a new month-12 secondary endpoint. - Added new endpoints to the overall study period and the month 12 to 24 open-label alendronate period. - Added the following new secondary endpoints through month 24 during the primary analysis period: clinical fracture, nonvertebral fracture, hip fracture, and clinical vertebral fracture. - Based on regulatory agency feedback, DXA BMD endpoints were added to the testing sequence for multiplicity adjustment.

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

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

    European Medicines Agency © 1995-Thu Dec 04 15:18:22 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA