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

    Summary
    EudraCT number
    		 2011-001456-11
    Trial protocol
    		 HU   BE   DK   PL   DE   GB   EE   CZ   ES   LV   LT  
    Global end of trial date
    28 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2018
    First version publication date
    03 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20070337
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01575834
    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
    28 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
    Protection of trial subjects
    This study was conducted in accordance with applicable local, Food and Drug Administration, and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. The study protocol, subject information, and informed consent form were reviewed and approved by the independent ethics committee (IEC) or institutional review board (IRB) for each study center. All subjects provided written informed consent before any protocol-specific screening procedures or any investigational products were administered and after the aims, methods, anticipated benefits, and potential hazards of the study were adequately explained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 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
    Colombia: 1822
    Country: Number of subjects enrolled
    Brazil: 816
    Country: Number of subjects enrolled
    Dominican Republic: 173
    Country: Number of subjects enrolled
    Argentina: 177
    Country: Number of subjects enrolled
    Mexico: 96
    Country: Number of subjects enrolled
    Poland: 1241
    Country: Number of subjects enrolled
    Czech Republic: 334
    Country: Number of subjects enrolled
    Hungary: 203
    Country: Number of subjects enrolled
    Lithuania: 112
    Country: Number of subjects enrolled
    Estonia: 110
    Country: Number of subjects enrolled
    Latvia: 51
    Country: Number of subjects enrolled
    Romania: 42
    Country: Number of subjects enrolled
    United Kingdom: 398
    Country: Number of subjects enrolled
    Denmark: 334
    Country: Number of subjects enrolled
    Germany: 67
    Country: Number of subjects enrolled
    Spain: 61
    Country: Number of subjects enrolled
    New Zealand: 34
    Country: Number of subjects enrolled
    Switzerland: 34
    Country: Number of subjects enrolled
    Belgium: 26
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    Japan: 492
    Country: Number of subjects enrolled
    Hong Kong: 231
    Country: Number of subjects enrolled
    India: 106
    Country: Number of subjects enrolled
    United States: 132
    Country: Number of subjects enrolled
    Canada: 63
    Worldwide total number of subjects
    7180
    EEA total number of subjects
    2979
    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)
    1525
    From 65 to 84 years
    5439
    85 years and over
    216

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 222 centers in Europe, Central/Latin America, Asia, North America, and Australia/New Zealand. The first participant enrolled on 15 March 2012 and the last participant enrolled on 06 December 2013.

    Pre-assignment
    Screening details
    		 Participants were randomized 1:1 to receive either romosozumab 210 mg or matched placebo for the 12-month, double-blind, placebo-controlled period. Randomization was stratified by age (< 75 years, ≥ 75 years) and prevalent vertebral fracture (yes, no), as determined by site staff at randomization based on local reading of the spine X-ray.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/Denosumab
    Arm description
    		 Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    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

    Investigational medicinal product name
    Denosumab
    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 every 6 months

    Arm title
    		 Romosozumab/Denosumab
    Arm description
    		 Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Denosumab
    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 every 6 months

    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
    Administered by subcutaneous injection once a month

    Number of subjects in period 1
    		Placebo/Denosumab Romosozumab/Denosumab
    Started
    3591
    3589
    Received Double-blind Treatment
    3582
    3575
    Completed Double-blind Period
    3205
    3185
    Completed 24-month Study Period
    3032
    2994
    Completed
    2892
    2851
    Not completed
    699
    738
         Consent withdrawn by subject
    352
    390
         Adverse event, non-fatal
    63
    61
         Administrative decision
    15
    33
         Death
    81
    74
         Other
    70
    70
         Protocol deviation
    4
    3
         Lost to follow-up
    55
    68
         Ineligibility determined
    5
    8
         Noncompliance
    52
    27
         Requirement for alternative therapy
    2
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo/Denosumab
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

    Reporting group title
    Romosozumab/Denosumab
    Reporting group description
    		 Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

    Reporting group values
    		 Placebo/Denosumab Romosozumab/Denosumab Total
    Number of subjects
    		 3591 3589 7180
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 757 768 1525
        From 65-84 years
    		 2727 2712 5439
        85 years and over
    		 107 109 216
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.8 ± 6.9 70.9 ± 7.0 -
    Gender Categorical
    Units: Subjects
        Female
    		 3591 3589 7180
        Male
    		 0 0 0
    Race
    Units: Subjects
        White
    		 2052 2063 4115
        Asian
    		 441 425 866
        Black or African American
    		 74 77 151
        American Indian/Alaska Native
    		 63 64 127
        Native Hawaiian/Other Pacific Islander
    		 1 0 1
        Multiple
    		 59 60 119
        Other
    		 901 900 1801
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1416 1427 2843
        Not Hispanic or Latino
    		 2175 2162 4337
    Prevalent Vertebral Fracture Strata per Randomization
    Strata per randomization for prevalent fracture were based on local reading of baseline spine radiographs.
    Units: Subjects
        Yes
    		 205 204 409
        No
    		 3386 3385 6771
    Age Strata per Randomization
    Units: Subjects
        < 75 years
    		 2471 2470 4941
        ≥ 75 years
    		 1120 1119 2239

    End points

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    End points reporting groups
    Reporting group title
    Placebo/Denosumab
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

    Reporting group title
    Romosozumab/Denosumab
    Reporting group description
    		 Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

    Primary: Percentage of Participants with New Vertebral Fracture Through Month 12

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    End point title
    		 Percentage of Participants with New Vertebral Fracture 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. The Genant semiquantitative scoring method was 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, > 40% reduction in anterior, middle, and/or posterior height. The primary analysis set for vertebral fractures includes all subjects with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 12 months, including subjects with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3322
    3321
    Units: percentage of participants
        number (not applicable)
    1.8
    0.5
    Statistical analysis title
    		 Analysis of New Vertebral Fracture To Month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6643
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 0.47
    Notes
    [1] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [2] - Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.

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

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    End point title
    		 Percentage of Participants with New Vertebral Fracture 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. The Genant semiquantitative scoring method was 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, > 40% reduction in anterior, middle, and/or posterior height. The primary analysis set for vertebral fractures includes all subjects with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including subjects with missing baseline Genant scores whose first postbaseline 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
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3327
    3325
    Units: percentage of participants
        number (not applicable)
    2.5
    0.6
    Statistical analysis title
    		 Analysis of New Vertebral Fracture To Month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6652
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 0.39
    Notes
    [3] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [4] - Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.

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

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    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 full analysis set consisted of all randomized participants. Last observation carried forward imputation (LOCF) was used for this analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    2.5
    1.6
    Statistical analysis title
    		 Analysis of Clinical Fracture Through Month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.008 [6]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.89
    Notes
    [5] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [6] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    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 full analysis set was used for this analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    2.1
    1.6
    Statistical analysis title
    		 Analysis of Nonvertebral Fracture Through Month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.096 [8]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.05
    Notes
    [7] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [8] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    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 as 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 full analysis set was used for the analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    3.6
    2.7
    Statistical analysis title
    		 Analysis of Nonvertebral Fracture Through Month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.057 [10]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.97
    Notes
    [9] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [10] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    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 full analysis set with LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    4.1
    2.8
    Statistical analysis title
    		 Analysis of Clinical Fracture Through Month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.096 [12]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.87
    Notes
    [11] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [12] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    End point title
    		 Percentage of Participants with a Major Nonvertebral Fracture Through Month 12
    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 full analysis set was used for the analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    1.5
    1.0
    Statistical analysis title
    		 Analysis of Major Nonvertebral Fracture
    Statistical analysis description
    Analysis of major nonvertebral fracture through month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.096 [14]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.02
    Notes
    [13] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [14] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    End point title
    		 Percentage of Participants with a Major Nonvertebral Fracture Through Month 24
    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 full analysis set was used for the analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    2.8
    1.9
    Statistical analysis title
    		 Analysis of Major Nonvertebral Fracture
    Statistical analysis description
    Analysis of major nonvertebral fracture through month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.096 [16]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.91
    Notes
    [15] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [16] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

    Secondary: Percentage of Participants with a New or Worsening Vertebral Fracture Through Month 12

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    End point title
    		 Percentage of Participants with a New or Worsening Vertebral Fracture Through Month 12
    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 primary analysis set for vertebral fractures with LOCF imputation was used for the analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3322
    3321
    Units: percentage of participants
        number (not applicable)
    1.8
    0.5
    Statistical analysis title
    		 Analysis of New or Worsening Vertebral Fracture
    Statistical analysis description
    Analysis of new or worsening vertebral fracture through month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6643
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.096 [18]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.49
    Notes
    [17] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [18] - Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.

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

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    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 primary analysis set for vertebral fractures with LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3327
    3325
    Units: percentage of participants
        number (not applicable)
    2.5
    0.7
    Statistical analysis title
    		 Analysis of New or Worsening Vertebral Fracture
    Statistical analysis description
    Analysis of new or worsening vertebral fracture through month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6652
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.096 [20]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 0.41
    Notes
    [19] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [20] - Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test

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

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    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 full analysis set was used for this analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    0.4
    0.2
    Statistical analysis title
    		 Analysis of Hip Fracture Through Month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.18 [22]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 1.35
    Notes
    [21] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [22] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    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 full analysis set was used for this analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    0.6
    0.3
    Statistical analysis title
    		 Analysis of Hip Fracture Through Month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.12 [24]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 1.04
    Notes
    [23] - A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.
    [24] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    End point title
    		 Percentage of Participants with a Major Osteoporotic Fracture Through Month 12
    End point description
    Major osteoporotic fractures included hip, forearm, or humerus fractures that were not associated with a pathologic fracture regardless of trauma severity, and clinical vertebral fractures. The full analysis set was used for this analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    1.8
    1.1
    Statistical analysis title
    		 Analysis of Major Osteoporotic Fracture
    Statistical analysis description
    Analysis of major osteoporotic fracture through month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012 [25]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.9
    Notes
    [25] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

    Secondary: Percentage of Participants with a Major Osteoporotic Fracture Through Month 24

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    End point title
    		 Percentage of Participants with a Major Osteoporotic Fracture Through Month 24
    End point description
    Major osteoporotic fractures included hip, forearm, or humerus fractures that were not associated with a pathologic fracture regardless of trauma severity, and clinical vertebral fractures. The full analysis set was used for this analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3591
    3589
    Units: percentage of participants
        number (not applicable)
    3.1
    1.9
    Statistical analysis title
    		 Analysis of Major Osteoporotic Fracture
    Statistical analysis description
    Analysis of major osteoporotic fracture through month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    7180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [26]
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.84
    Notes
    [26] - Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.

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

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    End point title
    		 Percentage of Participants with Multiple New or Worsening Vertebral Fractures Through Month 12
    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 primary analysis set for vertebral fractures with LOCF imputation was used for the analysis.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3322
    3321
    Units: percentage of participants
        number (not applicable)
    0.3
    0.03
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Analysis of multiple new or worsening vertebral fractures through month 12
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6643
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011 [27]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.87
    Notes
    [27] - Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.

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

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    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 primary analysis set for vertebral fractures with LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3327
    3325
    Units: percentage of participants
        number (not applicable)
    0.5
    0.03
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Analysis of multiple new or worsening vertebral fractures through month 24
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6652
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [28]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.44
    Notes
    [28] - Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.

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

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    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 primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3148
    3151
    Units: percent change
        least squares mean (standard error)
    0.4 ± 0.1
    13.1 ± 0.1
    Statistical analysis title
    		 Analysis of Lumbar Spine BMD at Month 12
    Statistical analysis description
    The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6299
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    12.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.4
         upper limit
    		 12.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

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

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    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 primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    2877
    2861
    Units: percent change
        least squares mean (standard error)
    5.5 ± 0.1
    16.6 ± 0.1
    Statistical analysis title
    		 Analysis of Lumbar Spine BMD at Month 24
    Statistical analysis description
    The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    5738
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    11.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.8
         upper limit
    		 11.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

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

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    End point title
    		 Percent Change from Baseline in Bone Mineral Density at 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 primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3210
    3197
    Units: percent change
        least squares mean (standard error)
    0.3 ± 0.1
    6.0 ± 0.1
    Statistical analysis title
    		 Analysis of Total Hip BMD at Month 12
    Statistical analysis description
    The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

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

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    End point title
    		 Percent Change from Baseline in Bone Mineral Density at 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 primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.
    End point type
    Secondary
    End point timeframe
    Baseline and month 24
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    2918
    2903
    Units: percent change
        least squares mean (standard error)
    3.2 ± 0.1
    8.5 ± 0.1
    Statistical analysis title
    		 Analysis of Total Hip BMD at Month 24
    Statistical analysis description
    The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    5821
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.1
         upper limit
    		 5.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

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

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    End point title
    		 Percent Change from Baseline in Bone Mineral Density at 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 primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and month 12
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    3210
    3197
    Units: percent change
        least squares mean (standard error)
    0.3 ± 0.1
    5.5 ± 0.1
    Statistical analysis title
    		 Analysis of Femoral Neck BMD at Month 12
    Statistical analysis description
    The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    6407
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 5.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

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

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    End point title
    		 Percent Change from Baseline in Bone Mineral Density at 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 primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and month 24
    End point values
    		 Placebo/Denosumab Romosozumab/Denosumab
    Number of subjects analysed
    2918
    2903
    Units: percent change
        least squares mean (standard error)
    2.3 ± 0.1
    7.3 ± 0.1
    Statistical analysis title
    		 Analysis of Femoral Neck BMD at Month 24
    Statistical analysis description
    The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.
    Comparison groups
    Placebo/Denosumab v Romosozumab/Denosumab
    Number of subjects included in analysis
    5821
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.7
         upper limit
    		 5.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double-blind treatment period: 12 months; Overall study: 36 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    12-Month Double-blind Period: Placebo
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month for 12 months.

    Reporting group title
    12-Month Double-blind Period: Romosozumab
    Reporting group description
    		 Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months.

    Reporting group title
    36-Month Study Period: Placebo/Denosumab
    Reporting group description
    		 Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

    Reporting group title
    36-Month Study Period: Romosozumab/Denosumab
    Reporting group description
    		 Participants received romosozumab 210 mg subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.

    Serious adverse events
    		 12-Month Double-blind Period: Placebo 12-Month Double-blind Period: Romosozumab 36-Month Study Period: Placebo/Denosumab 36-Month Study Period: Romosozumab/Denosumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    314 / 3576 (8.78%)
    344 / 3581 (9.61%)
    733 / 3576 (20.50%)
    728 / 3581 (20.33%)
         number of deaths (all causes)
    24
    29
    85
    72
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acral lentiginous melanoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    8 / 3576 (0.22%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Adrenal adenoma
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angiocentric lymphoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Benign neoplasm of spinal cord
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Benign pleural neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign soft tissue neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Bowen's disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Breast cancer
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    11 / 3576 (0.31%)
    8 / 3581 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Breast cancer female
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer in situ
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 stage III
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Bronchial carcinoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         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 / 1
    0 / 0
    Cervix carcinoma stage II
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choroid melanoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Colon adenoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         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
    Colon cancer metastatic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Colon neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Colorectal cancer
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Granular cell tumour
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Haemangioma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hepatic cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Intraocular melanoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    6 / 3576 (0.17%)
    7 / 3581 (0.20%)
    10 / 3576 (0.28%)
    13 / 3581 (0.36%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 7
    2 / 13
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    1 / 6
    Lymphoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of conjunctiva
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Mantle cell lymphoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Metastases to liver
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 malignant melanoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nasopharyngeal cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm of appendix
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurofibroma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma recurrent
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Ovarian cancer
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Paget's disease of nipple
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancoast's tumour
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Paranasal sinus benign neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phaeochromocytoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Plasma cell myeloma
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyogenic granuloma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer stage II
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal adenoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Skin cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Squamous cell carcinoma of pharynx
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the hypopharynx
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Deep vein thrombosis
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    Dry gangrene
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Hypertension
         subjects affected / exposed
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
    12 / 3576 (0.34%)
    15 / 3581 (0.42%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
    0 / 14
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    6 / 3581 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 arterial occlusive disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Vasculitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Surgical and medical procedures
    Cardiac pacemaker replacement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 operation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hysterectomy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Osteosynthesis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary resection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Rehabilitation therapy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scar excision
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
    9 / 3576 (0.25%)
    13 / 3581 (0.36%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 9
    1 / 13
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    0 / 9
    1 / 13
    General physical health deterioration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device discomfort
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal dryness
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 2
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
    3 / 3576 (0.08%)
    10 / 3581 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 3
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 4
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hypersensitivity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Activities of daily living impaired
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immobile
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Cervical dysplasia
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysfunctional uterine bleeding
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Female genital tract fistula
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Pelvic haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urogenital prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Uterine polyp
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    5 / 3581 (0.14%)
    2 / 3576 (0.06%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Acute respiratory failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Alveolitis allergic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    8 / 3581 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Bronchiectasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choking sensation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    15 / 3576 (0.42%)
    6 / 3581 (0.17%)
    28 / 3576 (0.78%)
    22 / 3581 (0.61%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 6
    0 / 35
    1 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Epistaxis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Haemoptysis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumothorax
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    9 / 3581 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    Pulmonary mass
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Respiratory failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Sinus polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Anxiety
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Anxiety disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 I disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Confusional state
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Personality change due to a general medical condition
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudodementia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Schizophreniform disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Transient psychosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Biliary colic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Biliary dilatation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 sclerosing
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Cholecystitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         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
    Cholecystitis acute
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    8 / 3576 (0.22%)
    5 / 3581 (0.14%)
    11 / 3576 (0.31%)
    12 / 3581 (0.34%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Hepatic cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Jaundice
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Jaundice cholestatic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Portal hypertension
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Sphincter of Oddi dysfunction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood lactic acid increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Body mass index increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric pH decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    General physical condition abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Influenza B virus test positive
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Animal bite
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cataract operation complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Eye injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Face injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 bones fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    8 / 3576 (0.22%)
    3 / 3581 (0.08%)
    14 / 3576 (0.39%)
    11 / 3581 (0.31%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    19 / 3576 (0.53%)
    9 / 3581 (0.25%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 19
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    8 / 3576 (0.22%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Foreign body
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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 stoma complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    8 / 3576 (0.22%)
    8 / 3581 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Internal injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 dislocation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Meniscus injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 concussion syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Postoperative adhesion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative delirium
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Radial head dislocation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    17 / 3576 (0.48%)
    14 / 3581 (0.39%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 17
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Spinal fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         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 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma site ischaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Subdural haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         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
    Tendon rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Ulna fracture
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    12 / 3576 (0.34%)
    8 / 3581 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine dehiscence
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 necrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 disorders
    Acute coronary syndrome
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
    10 / 3576 (0.28%)
    16 / 3581 (0.45%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 11
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    Adams-Stokes syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Angina pectoris
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    Angina unstable
         subjects affected / exposed
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
    9 / 3576 (0.25%)
    10 / 3581 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease mixed
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Aortic valve stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Atrial fibrillation
         subjects affected / exposed
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
    18 / 3576 (0.50%)
    17 / 3581 (0.47%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    1 / 20
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 2
    Cardiac failure
         subjects affected / exposed
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
    7 / 3576 (0.20%)
    10 / 3581 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    4 / 3576 (0.11%)
    7 / 3581 (0.20%)
    8 / 3576 (0.22%)
    10 / 3581 (0.28%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 8
    1 / 9
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 3
    Cardiogenic shock
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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 / 1
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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 / 2
    0 / 1
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cor pulmonale
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Coronary artery stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Low cardiac output syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Mitral valve stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    9 / 3576 (0.25%)
    8 / 3581 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 3
    Myocardial ischaemia
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paroxysmal atrioventricular block
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Prinzmetal angina
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Sinus node dysfunction
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Nervous system disorders
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arachnoid cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 ganglia stroke
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Brain oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Brain stem ischaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Carotid artery occlusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Carotid artery stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar ischaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Cerebral haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cerebral infarction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    14 / 3581 (0.39%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
    0 / 11
    0 / 14
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 1
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Cervical myelopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Cervicogenic headache
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Cognitive disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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 / 0
    Depressed level of consciousness
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic coma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Dizziness
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Headache
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hydrocephalus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Internal carotid artery kinking
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Ischaemic stroke
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    9 / 3576 (0.25%)
    13 / 3581 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Loss of consciousness
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meralgia paraesthetica
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Motor dysfunction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve root compression
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Neuropathy peripheral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nystagmus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paralysis recurrent laryngeal nerve
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paresis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         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
    Polyneuropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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-traumatic headache
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Sciatica
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stupor
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    7 / 3576 (0.20%)
    9 / 3581 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    6 / 3576 (0.17%)
    13 / 3581 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 7
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Anaemia
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    9 / 3576 (0.25%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Coagulopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocoagulable state
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Neutropenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Pernicious anaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Deafness unilateral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Angle closure glaucoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Blindness unilateral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
    14 / 3576 (0.39%)
    13 / 3581 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 16
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystoid macular oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Lens disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Posterior capsule rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Retinal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Uveitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    10 / 3581 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
    0 / 9
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Anal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Colitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Dyspepsia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Enteritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Faecaloma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Fistula of small intestine
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 polyps
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal hypomotility
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Haemorrhoids
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Hernial eventration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hiatus hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Inguinal hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Large intestine perforation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Melaena
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 cyst rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 fistula
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    6 / 3581 (0.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal adhesions
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Rectal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reflux gastritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Small intestinal obstruction
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Toothache
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis exfoliative
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Granuloma annulare
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ingrowing nail
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Lichen sclerosus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Rash macular
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Skin ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute prerenal failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocalyx
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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 failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Renal impairment
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Stress urinary incontinence
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Ureteric perforation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 tract inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Primary hyperaldosteronism
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coccydynia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Haemarthrosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc compression
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Osteitis deformans
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    15 / 3576 (0.42%)
    6 / 3581 (0.17%)
    27 / 3576 (0.76%)
    21 / 3581 (0.59%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 7
    0 / 31
    1 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in jaw
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    10 / 3576 (0.28%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 13
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Spondylolisthesis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebic colitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Appendicitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Bacterial tracheitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    3 / 3576 (0.08%)
    9 / 3581 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Bronchitis viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    11 / 3576 (0.31%)
    11 / 3581 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 13
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chlamydial infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 sinusitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Dermatitis infected
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Enterobacter bacteraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Hepatitis B
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hepatitis C
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal gangrene
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Labyrinthitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Lymphangitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Meningitis pneumococcal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Osteomyelitis chronic
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Perichondritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Perineal abscess
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phlebitis infective
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    10 / 3576 (0.28%)
    19 / 3581 (0.53%)
    37 / 3576 (1.03%)
    44 / 3581 (1.23%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 24
    0 / 44
    2 / 51
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    Pneumonia bacterial
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia cryptococcal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 mycoplasmal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 tuberculosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelocystitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         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 / 1
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyometra
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Pyonephrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Sinusitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Tick-borne viral encephalitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Ureteritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    14 / 3576 (0.39%)
    17 / 3581 (0.47%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 19
    1 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginitis bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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 abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Dehydration
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    7 / 3581 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (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
    Folate deficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hypocalcaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypochloraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         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
    Hyponatraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         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
    Hyponatraemic syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Hypoosmolar state
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (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
    Malnutrition
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mineral metabolism disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         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
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         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: Placebo 12-Month Double-blind Period: Romosozumab 36-Month Study Period: Placebo/Denosumab 36-Month Study Period: Romosozumab/Denosumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2823 / 3576 (78.94%)
    2773 / 3581 (77.44%)
    3130 / 3576 (87.53%)
    3112 / 3581 (86.90%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    3
    0
    4
    0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Adenoma benign
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Adrenal neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Angiomyolipoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Anogenital warts
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Basal cell carcinoma
         subjects affected / exposed
    11 / 3576 (0.31%)
    6 / 3581 (0.17%)
    17 / 3576 (0.48%)
    18 / 3581 (0.50%)
         occurrences all number
    12
    7
    19
    21
    Benign bone neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Benign breast neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    4
    1
    Benign gastric neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    3
    1
    Benign neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Benign neoplasm of cornea
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Benign neoplasm of skin
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    1
    4
    4
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    9 / 3576 (0.25%)
    7 / 3581 (0.20%)
    13 / 3576 (0.36%)
    17 / 3581 (0.47%)
         occurrences all number
    9
    7
    14
    17
    Benign ovarian tumour
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Benign pleural neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Benign renal neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Benign soft tissue neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Bowen's disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    0
    3
    Breast cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Breast fibroma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cancer pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Colon adenoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    3
    2
    5
    Colon cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Ear neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Enchondromatosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Eye naevus
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Fibroma
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    4
    1
    Fibromatosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Gastric neoplasm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemangioma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    4
    0
    Haemangioma of bone
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Haemangioma of liver
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Haemangioma of skin
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hair follicle tumour benign
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Hepatic neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intraductal papilloma of breast
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Juvenile melanoma benign
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Keratoacanthoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Kidney angiomyolipoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Leiomyoma
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    5
    2
    Lipofibroma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Lipoma
         subjects affected / exposed
    2 / 3576 (0.06%)
    6 / 3581 (0.17%)
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
         occurrences all number
    2
    6
    6
    8
    Lymphoproliferative disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Melanocytic naevus
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    1
    5
    4
    Meningioma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Meningioma benign
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Metastases to lung
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Oral haemangioma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Ovarian cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Polycythaemia vera
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pyogenic granuloma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Renal neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
    9 / 3576 (0.25%)
    12 / 3581 (0.34%)
         occurrences all number
    6
    7
    10
    13
    Skin cancer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Skin papilloma
         subjects affected / exposed
    2 / 3576 (0.06%)
    6 / 3581 (0.17%)
    3 / 3576 (0.08%)
    9 / 3581 (0.25%)
         occurrences all number
    2
    6
    3
    10
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    3
    1
    4
    Sweat gland tumour
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Thyroid adenoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Thyroid neoplasm
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
         occurrences all number
    0
    4
    3
    7
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Angiosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Aortic aneurysm
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    5
    4
    Aortic arteriosclerosis
         subjects affected / exposed
    6 / 3576 (0.17%)
    11 / 3581 (0.31%)
    30 / 3576 (0.84%)
    21 / 3581 (0.59%)
         occurrences all number
    6
    12
    30
    22
    Aortic calcification
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Aortic dilatation
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    5
    3
    Aortic dissection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Aortic elongation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Aortic stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    0
    4
    5
    Aortic thrombosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Arterial disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Arterial occlusive disease
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    2
    2
    Arterial stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arteriosclerosis
         subjects affected / exposed
    14 / 3576 (0.39%)
    15 / 3581 (0.42%)
    33 / 3576 (0.92%)
    30 / 3581 (0.84%)
         occurrences all number
    15
    16
    35
    31
    Blood pressure fluctuation
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    5
    1
    5
    5
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Capillary fragility
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Capillary leak syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    3
    2
    Diastolic hypotension
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Embolism
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Embolism arterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Essential hypertension
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    4
    6
    5
    Extravasation blood
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Flushing
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    2
    3
    Haematoma
         subjects affected / exposed
    20 / 3576 (0.56%)
    20 / 3581 (0.56%)
    27 / 3576 (0.76%)
    40 / 3581 (1.12%)
         occurrences all number
    25
    23
    32
    44
    Haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hot flush
         subjects affected / exposed
    12 / 3576 (0.34%)
    11 / 3581 (0.31%)
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
         occurrences all number
    13
    12
    13
    14
    Hyperaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hypertension
         subjects affected / exposed
    260 / 3576 (7.27%)
    219 / 3581 (6.12%)
    411 / 3576 (11.49%)
    384 / 3581 (10.72%)
         occurrences all number
    274
    244
    461
    441
    Hypertensive angiopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Hypertensive crisis
         subjects affected / exposed
    7 / 3576 (0.20%)
    12 / 3581 (0.34%)
    16 / 3576 (0.45%)
    21 / 3581 (0.59%)
         occurrences all number
    8
    13
    17
    24
    Hypertensive emergency
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    3
    1
    Hypotension
         subjects affected / exposed
    20 / 3576 (0.56%)
    7 / 3581 (0.20%)
    24 / 3576 (0.67%)
    17 / 3581 (0.47%)
         occurrences all number
    21
    7
    27
    17
    Hypovolaemic shock
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Intermittent claudication
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    3
    3
    3
    Ischaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Labile blood pressure
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Lymphoedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Lymphostasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Microangiopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Orthostatic hypertension
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Orthostatic hypotension
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Peripheral arterial occlusive disease
         subjects affected / exposed
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
    9 / 3576 (0.25%)
    15 / 3581 (0.42%)
         occurrences all number
    6
    8
    11
    15
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    3
    3
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Peripheral circulatory failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Peripheral embolism
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Peripheral ischaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Peripheral venous disease
         subjects affected / exposed
    14 / 3576 (0.39%)
    19 / 3581 (0.53%)
    26 / 3576 (0.73%)
    32 / 3581 (0.89%)
         occurrences all number
    15
    21
    27
    34
    Phlebitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    9 / 3581 (0.25%)
         occurrences all number
    2
    3
    6
    10
    Phlebitis superficial
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    3
    4
    Phlebolith
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Poor peripheral circulation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Post thrombotic syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    1
    4
    3
    Shock
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spider vein
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Subgaleal haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Temporal arteritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    3
    7
    5
    Thrombophlebitis superficial
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    2
    6
    3
    Thrombosed varicose vein
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thrombosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Varicophlebitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Varicose ulceration
         subjects affected / exposed
    7 / 3576 (0.20%)
    2 / 3581 (0.06%)
    9 / 3576 (0.25%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    2
    10
    8
    Varicose vein
         subjects affected / exposed
    25 / 3576 (0.70%)
    17 / 3581 (0.47%)
    46 / 3576 (1.29%)
    39 / 3581 (1.09%)
         occurrences all number
    26
    17
    50
    40
    Varicose vein ruptured
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Vascular calcification
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vascular fragility
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Vascular insufficiency
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Vascular pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vascular rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vasculitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Vasodilatation
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Vein disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Venous thrombosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Venous thrombosis limb
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    1
    2
    4
    Withdrawal hypertension
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    Abdominal hernia repair
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Artificial crown procedure
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Bladder repair
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Bunion operation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cancer surgery
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Cataract operation
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    8 / 3581 (0.22%)
         occurrences all number
    2
    2
    4
    9
    Colectomy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Colostomy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Corneal transplant
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Cyst removal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dental care
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Dental cleaning
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dental prosthesis placement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatofibroma removal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Endodontic procedure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Eye operation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hip arthroplasty
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Hypotensive anaesthesia procedure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Inguinal hernia repair
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Intervertebral disc operation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intraocular lens implant
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Large intestinal polypectomy
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Lip operation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nail operation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Peripheral nerve operation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Plastic surgery to the face
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Rotator cuff repair
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin neoplasm excision
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    3
    Spinal fusion surgery
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Suture insertion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Thyroidectomy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Toe operation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tooth extraction
         subjects affected / exposed
    4 / 3576 (0.11%)
    8 / 3581 (0.22%)
    15 / 3576 (0.42%)
    22 / 3581 (0.61%)
         occurrences all number
    4
    9
    16
    23
    Wisdom teeth removal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Administration site erythema
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    3
    0
    3
    Administration site pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Administration site reaction
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Adverse drug reaction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Application site bruise
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Application site dermatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Application site eczema
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Application site pruritus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Application site rash
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Asthenia
         subjects affected / exposed
    79 / 3576 (2.21%)
    84 / 3581 (2.35%)
    111 / 3576 (3.10%)
    117 / 3581 (3.27%)
         occurrences all number
    94
    97
    135
    140
    Axillary pain
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Calcinosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Catheter site haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Catheter site pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
         occurrences all number
    3
    6
    7
    9
    Chest pain
         subjects affected / exposed
    30 / 3576 (0.84%)
    30 / 3581 (0.84%)
    44 / 3576 (1.23%)
    39 / 3581 (1.09%)
         occurrences all number
    30
    31
    44
    40
    Chills
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    3
    3
    4
    5
    Crying
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cyst
         subjects affected / exposed
    4 / 3576 (0.11%)
    7 / 3581 (0.20%)
    7 / 3576 (0.20%)
    12 / 3581 (0.34%)
         occurrences all number
    4
    7
    7
    12
    Discomfort
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    3
    3
    Drug intolerance
         subjects affected / exposed
    7 / 3576 (0.20%)
    10 / 3581 (0.28%)
    12 / 3576 (0.34%)
    14 / 3581 (0.39%)
         occurrences all number
    7
    10
    12
    14
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    4
    3
    Face oedema
         subjects affected / exposed
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    5
    6
    5
    Facial pain
         subjects affected / exposed
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
    11 / 3576 (0.31%)
    7 / 3581 (0.20%)
         occurrences all number
    7
    4
    12
    8
    Fat tissue increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Fatigue
         subjects affected / exposed
    52 / 3576 (1.45%)
    48 / 3581 (1.34%)
    61 / 3576 (1.71%)
    61 / 3581 (1.70%)
         occurrences all number
    59
    56
    70
    71
    Feeling abnormal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Feeling cold
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    2 / 3576 (0.06%)
    8 / 3581 (0.22%)
    4 / 3576 (0.11%)
    9 / 3581 (0.25%)
         occurrences all number
    2
    10
    4
    11
    Feeling of body temperature change
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Gait disturbance
         subjects affected / exposed
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
    8 / 3576 (0.22%)
    9 / 3581 (0.25%)
         occurrences all number
    4
    6
    8
    11
    General physical health deterioration
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Generalised oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    2
    3
    4
    Granuloma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Impaired healing
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Implant site cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Implant site haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Implant site pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Inflammation
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    3
    2
    Influenza like illness
         subjects affected / exposed
    39 / 3576 (1.09%)
    29 / 3581 (0.81%)
    54 / 3576 (1.51%)
    46 / 3581 (1.28%)
         occurrences all number
    43
    30
    62
    50
    Infusion site bruising
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Injection site bruising
         subjects affected / exposed
    20 / 3576 (0.56%)
    29 / 3581 (0.81%)
    21 / 3576 (0.59%)
    29 / 3581 (0.81%)
         occurrences all number
    24
    32
    25
    32
    Injection site cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    0
    2
    Injection site dermatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Injection site erythema
         subjects affected / exposed
    5 / 3576 (0.14%)
    54 / 3581 (1.51%)
    5 / 3576 (0.14%)
    56 / 3581 (1.56%)
         occurrences all number
    5
    110
    5
    113
    Injection site haematoma
         subjects affected / exposed
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
         occurrences all number
    6
    9
    6
    9
    Injection site haemorrhage
         subjects affected / exposed
    13 / 3576 (0.36%)
    13 / 3581 (0.36%)
    14 / 3576 (0.39%)
    13 / 3581 (0.36%)
         occurrences all number
    15
    13
    16
    13
    Injection site hypersensitivity
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    8
    1
    8
    Injection site induration
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    5
    1
    5
    Injection site inflammation
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    1
    3
    Injection site mass
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Injection site nodule
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Injection site oedema
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    3
    1
    3
    Injection site pain
         subjects affected / exposed
    46 / 3576 (1.29%)
    62 / 3581 (1.73%)
    47 / 3576 (1.31%)
    63 / 3581 (1.76%)
         occurrences all number
    75
    92
    76
    94
    Injection site papule
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Injection site paraesthesia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    10
    1
    10
    1
    Injection site pruritus
         subjects affected / exposed
    7 / 3576 (0.20%)
    27 / 3581 (0.75%)
    7 / 3576 (0.20%)
    28 / 3581 (0.78%)
         occurrences all number
    8
    51
    8
    52
    Injection site rash
         subjects affected / exposed
    2 / 3576 (0.06%)
    13 / 3581 (0.36%)
    2 / 3576 (0.06%)
    13 / 3581 (0.36%)
         occurrences all number
    3
    23
    3
    23
    Injection site reaction
         subjects affected / exposed
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    5
    1
    5
    Injection site swelling
         subjects affected / exposed
    1 / 3576 (0.03%)
    16 / 3581 (0.45%)
    1 / 3576 (0.03%)
    16 / 3581 (0.45%)
         occurrences all number
    1
    36
    1
    37
    Injection site urticaria
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    8
    1
    8
    Injection site warmth
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    3
    0
    3
    Injury associated with device
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Ischaemic ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Local swelling
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Localised oedema
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    2
    1
    Malaise
         subjects affected / exposed
    18 / 3576 (0.50%)
    17 / 3581 (0.47%)
    29 / 3576 (0.81%)
    22 / 3581 (0.61%)
         occurrences all number
    20
    20
    32
    25
    Mass
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    0
    2
    2
    Medical device pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Mucosal dryness
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Mucosal inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Nodule
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    1
    4
    3
    Non-cardiac chest pain
         subjects affected / exposed
    23 / 3576 (0.64%)
    26 / 3581 (0.73%)
    42 / 3576 (1.17%)
    36 / 3581 (1.01%)
         occurrences all number
    23
    27
    47
    38
    Oedema
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    2
    2
    Oedema peripheral
         subjects affected / exposed
    67 / 3576 (1.87%)
    86 / 3581 (2.40%)
    97 / 3576 (2.71%)
    127 / 3581 (3.55%)
         occurrences all number
    74
    96
    114
    139
    Pain
         subjects affected / exposed
    40 / 3576 (1.12%)
    39 / 3581 (1.09%)
    56 / 3576 (1.57%)
    45 / 3581 (1.26%)
         occurrences all number
    42
    42
    59
    49
    Pelvic mass
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    20 / 3576 (0.56%)
    20 / 3581 (0.56%)
    30 / 3576 (0.84%)
    34 / 3581 (0.95%)
         occurrences all number
    22
    23
    32
    40
    Polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Puncture site haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Puncture site oedema
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Puncture site pain
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    2
    2
    Puncture site reaction
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Pyrexia
         subjects affected / exposed
    66 / 3576 (1.85%)
    49 / 3581 (1.37%)
    74 / 3576 (2.07%)
    58 / 3581 (1.62%)
         occurrences all number
    79
    61
    88
    70
    Sensation of foreign body
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Sense of oppression
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    3
    0
    3
    Soft tissue inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Suprapubic pain
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Swelling
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Temperature intolerance
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Thirst
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    0
    3
    1
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Vaccination site bruising
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vaccination site induration
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vaccination site pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vessel puncture site bruise
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    4
    4
    5
    Vessel puncture site erythema
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vessel puncture site haematoma
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    3
    1
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Vessel puncture site pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vessel puncture site reaction
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Xerosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Immune system disorders
    Allergic oedema
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    4
    1
    Allergy to animal
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Allergy to arthropod bite
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    2
    2
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    2
    1
    Allergy to chemicals
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Allergy to plants
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Allergy to vaccine
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Atopy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Contrast media allergy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Drug hypersensitivity
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    14 / 3576 (0.39%)
    15 / 3581 (0.42%)
         occurrences all number
    5
    3
    14
    18
    Food allergy
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    3
    2
    5
    Hypersensitivity
         subjects affected / exposed
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
    10 / 3576 (0.28%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    5
    10
    7
    Mite allergy
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Multiple allergies
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Rubber sensitivity
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Seasonal allergy
         subjects affected / exposed
    9 / 3576 (0.25%)
    6 / 3581 (0.17%)
    18 / 3576 (0.50%)
    15 / 3581 (0.42%)
         occurrences all number
    9
    6
    19
    15
    Transplant rejection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Type I hypersensitivity
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Social circumstances
    Bereavement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Dental prosthesis user
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Family stress
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Immobile
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Menopause
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Stress at work
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Anisomastia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Atrophic vulvovaginitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    4
    4
    6
    Breast calcifications
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Breast cyst
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
         occurrences all number
    3
    3
    5
    6
    Breast discharge
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Breast disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Breast engorgement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Breast enlargement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Breast haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Breast mass
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    2
    7
    4
    Breast pain
         subjects affected / exposed
    7 / 3576 (0.20%)
    8 / 3581 (0.22%)
    12 / 3576 (0.34%)
    12 / 3581 (0.34%)
         occurrences all number
    7
    9
    12
    13
    Breast swelling
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Breast ulceration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cervical dysplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Cervical polyp
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cervix inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Colpocele
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Cystocele
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    9 / 3576 (0.25%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    3
    9
    7
    Dysfunctional uterine bleeding
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    1
    4
    4
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    4
    0
    Endometrial hypoplasia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Endometrial thickening
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Genital atrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Genital haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Genital labial adhesions
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Genital prolapse
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    1
    4
    3
    Genital rash
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hydrometra
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hysterocele
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Mammary duct ectasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Menopausal symptoms
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Ovarian cyst
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    8 / 3576 (0.22%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    2
    8
    5
    Pelvic floor muscle weakness
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pelvic haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pelvic pain
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    2
    5
    3
    Perineal pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Postmenopausal haemorrhage
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    5
    4
    Pruritus genital
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Rectocele
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    2
    1
    Urogenital prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Uterine disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Uterine mass
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Uterine polyp
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    0
    2
    4
    Uterine prolapse
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    2
    6
    3
    Uterovaginal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Vaginal haemorrhage
         subjects affected / exposed
    8 / 3576 (0.22%)
    3 / 3581 (0.08%)
    8 / 3576 (0.22%)
    3 / 3581 (0.08%)
         occurrences all number
    12
    3
    12
    4
    Vaginal polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vaginal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    3
    2
    Varicocele
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vulva cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vulval leukoplakia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal dryness
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
         occurrences all number
    4
    3
    6
    4
    Vulvovaginal pruritus
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    6 / 3581 (0.17%)
         occurrences all number
    7
    4
    9
    6
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Allergic bronchitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    1
    4
    Allergic cough
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    4
    2
    5
    4
    Allergic respiratory symptom
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Allergic sinusitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Asthma
         subjects affected / exposed
    15 / 3576 (0.42%)
    22 / 3581 (0.61%)
    29 / 3576 (0.81%)
    39 / 3581 (1.09%)
         occurrences all number
    17
    29
    33
    52
    Asthmatic crisis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Atelectasis
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    5
    4
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Bronchial obstruction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bronchiectasis
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    11 / 3576 (0.31%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    3
    11
    5
    Bronchitis chronic
         subjects affected / exposed
    7 / 3576 (0.20%)
    11 / 3581 (0.31%)
    15 / 3576 (0.42%)
    16 / 3581 (0.45%)
         occurrences all number
    7
    12
    17
    19
    Bronchospasm
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    9 / 3576 (0.25%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    9
    3
    Catarrh
         subjects affected / exposed
    8 / 3576 (0.22%)
    3 / 3581 (0.08%)
    13 / 3576 (0.36%)
    5 / 3581 (0.14%)
         occurrences all number
    8
    3
    15
    6
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    35 / 3576 (0.98%)
    29 / 3581 (0.81%)
    60 / 3576 (1.68%)
    51 / 3581 (1.42%)
         occurrences all number
    40
    38
    85
    68
    Chronic respiratory failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    117 / 3576 (3.27%)
    130 / 3581 (3.63%)
    179 / 3576 (5.01%)
    189 / 3581 (5.28%)
         occurrences all number
    128
    140
    202
    217
    Diaphragmatic abnormal relaxation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Diaphragmatic disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Dry throat
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Dysphonia
         subjects affected / exposed
    10 / 3576 (0.28%)
    12 / 3581 (0.34%)
    10 / 3576 (0.28%)
    22 / 3581 (0.61%)
         occurrences all number
    10
    12
    11
    22
    Dyspnoea
         subjects affected / exposed
    23 / 3576 (0.64%)
    33 / 3581 (0.92%)
    36 / 3576 (1.01%)
    50 / 3581 (1.40%)
         occurrences all number
    24
    35
    39
    53
    Dyspnoea exertional
         subjects affected / exposed
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
         occurrences all number
    9
    10
    12
    14
    Emphysema
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    11 / 3581 (0.31%)
         occurrences all number
    1
    4
    7
    12
    Epistaxis
         subjects affected / exposed
    19 / 3576 (0.53%)
    24 / 3581 (0.67%)
    26 / 3576 (0.73%)
    35 / 3581 (0.98%)
         occurrences all number
    22
    29
    35
    41
    Haemoptysis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    3
    3
    Haemothorax
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hiccups
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Hydrothorax
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoventilation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    3
    2
    Increased bronchial secretion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Increased upper airway secretion
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Interstitial lung disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Laryngeal disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    3
    1
    Laryngeal inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Laryngitis allergic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Larynx irritation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Lower respiratory tract inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Lung consolidation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lung cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Lung disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    4
    2
    Lung infiltration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mediastinal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Mouth breathing
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    4 / 3581 (0.11%)
         occurrences all number
    6
    4
    9
    6
    Nasal discomfort
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasal dryness
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Nasal inflammation
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Nasal mucosal disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nasal mucosal hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Nasal obstruction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Nasal oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Nasal polyps
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Nasal pruritus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Nasal septum deviation
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    3
    0
    5
    Nasal septum perforation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Obstructive airways disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    26 / 3576 (0.73%)
    26 / 3581 (0.73%)
    35 / 3576 (0.98%)
    39 / 3581 (1.09%)
         occurrences all number
    27
    30
    36
    44
    Orthopnoea
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pharyngeal haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngeal inflammation
         subjects affected / exposed
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    6
    3
    6
    3
    Pleural disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pleural effusion
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    2
    8
    4
    Pleural thickening
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Pleurisy
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Pneumonia aspiration
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pneumonitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Productive cough
         subjects affected / exposed
    10 / 3576 (0.28%)
    15 / 3581 (0.42%)
    14 / 3576 (0.39%)
    20 / 3581 (0.56%)
         occurrences all number
    10
    15
    14
    20
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Pulmonary artery thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary calcification
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary cavitation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    2
    5
    5
    Pulmonary embolism
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    4
    2
    Pulmonary granuloma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary hypertension
         subjects affected / exposed
    3 / 3576 (0.08%)
    9 / 3581 (0.25%)
    5 / 3576 (0.14%)
    18 / 3581 (0.50%)
         occurrences all number
    3
    9
    5
    18
    Pulmonary infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pulmonary mass
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    1
    5
    4
    Pulmonary oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rales
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    4
    3
    Reflux laryngitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory acidosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Respiratory distress
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Respiratory failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    3
    2
    Rhinalgia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Rhinitis allergic
         subjects affected / exposed
    26 / 3576 (0.73%)
    23 / 3581 (0.64%)
    39 / 3576 (1.09%)
    32 / 3581 (0.89%)
         occurrences all number
    26
    24
    39
    34
    Rhinorrhoea
         subjects affected / exposed
    6 / 3576 (0.17%)
    9 / 3581 (0.25%)
    14 / 3576 (0.39%)
    15 / 3581 (0.42%)
         occurrences all number
    7
    9
    15
    15
    Sinus congestion
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    4
    1
    Sinus disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    2
    Sinus polyp
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    7 / 3581 (0.20%)
         occurrences all number
    2
    2
    4
    7
    Sneezing
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sputum discoloured
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sputum retention
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    2
    1
    5
    Throat tightness
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tonsillar inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tonsillolith
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    2
    7
    4
    Upper-airway cough syndrome
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    3
    1
    Vasomotor rhinitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vocal cord disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Vocal cord thickening
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    1
    3
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    2
    2
    2
    Abnormal dreams
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Acute stress disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Adjustment disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    2
    Adjustment disorder with depressed mood
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    3
    4
    3
    Affective disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Agitation
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Alcohol abuse
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Alcoholic hangover
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Anxiety
         subjects affected / exposed
    27 / 3576 (0.76%)
    25 / 3581 (0.70%)
    37 / 3576 (1.03%)
    42 / 3581 (1.17%)
         occurrences all number
    29
    25
    39
    42
    Anxiety disorder
         subjects affected / exposed
    7 / 3576 (0.20%)
    2 / 3581 (0.06%)
    16 / 3576 (0.45%)
    6 / 3581 (0.17%)
         occurrences all number
    8
    2
    17
    6
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Bipolar II disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Bipolar disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Bruxism
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Bulimia nervosa
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cardiovascular somatic symptom disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Confusional state
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    3
    3
    Conversion disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Delirium
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    0
    5
    3
    Depressed mood
         subjects affected / exposed
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
    12 / 3576 (0.34%)
    7 / 3581 (0.20%)
         occurrences all number
    6
    5
    12
    7
    Depression
         subjects affected / exposed
    42 / 3576 (1.17%)
    47 / 3581 (1.31%)
    93 / 3576 (2.60%)
    78 / 3581 (2.18%)
         occurrences all number
    43
    47
    100
    81
    Depressive symptom
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Disorientation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Emotional disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Encopresis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Feelings of worthlessness
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Grief reaction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hallucination
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hallucination, auditory
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Head banging
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Illusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Initial insomnia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Insomnia
         subjects affected / exposed
    68 / 3576 (1.90%)
    72 / 3581 (2.01%)
    101 / 3576 (2.82%)
    105 / 3581 (2.93%)
         occurrences all number
    70
    75
    110
    112
    Irritability
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Listless
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Major depression
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    3
    0
    4
    0
    Mental disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Mental fatigue
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Middle insomnia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Mood altered
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    2
    1
    Mood disorder due to a general medical condition
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Nervousness
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Neurosis
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    4
    2
    Nicotine dependence
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Panic attack
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    0
    3
    3
    Panic disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Persistent depressive disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Personality change due to a general medical condition
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Psychotic disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychotic disorder due to a general medical condition
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Restlessness
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    2
    Schizophreniform disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
         occurrences all number
    7
    7
    9
    10
    Somatic symptom disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Stress
         subjects affected / exposed
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
    9 / 3576 (0.25%)
    5 / 3581 (0.14%)
         occurrences all number
    6
    3
    9
    5
    Tic
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Withdrawal syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Product issues
    Device breakage
         subjects affected / exposed
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
         occurrences all number
    6
    5
    6
    6
    Device dislocation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Device extrusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Device failure
         subjects affected / exposed
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
         occurrences all number
    3
    7
    3
    10
    Device loosening
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Device malfunction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Bile duct obstruction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bile duct stone
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    2
    3
    Biliary colic
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    0
    5
    1
    Biliary cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Biliary dilatation
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Biliary tract disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cholangitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    1
    0
    3
    Cholecystitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    1
    2
    Cholecystitis chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Cholelithiasis
         subjects affected / exposed
    22 / 3576 (0.62%)
    20 / 3581 (0.56%)
    44 / 3576 (1.23%)
    37 / 3581 (1.03%)
         occurrences all number
    22
    20
    45
    37
    Drug-induced liver injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatty liver alcoholic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Gallbladder cholesterolosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gallbladder polyp
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    6
    2
    Hepatic calcification
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Hepatic cyst
         subjects affected / exposed
    18 / 3576 (0.50%)
    6 / 3581 (0.17%)
    28 / 3576 (0.78%)
    10 / 3581 (0.28%)
         occurrences all number
    18
    6
    29
    10
    Hepatic failure
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatic lesion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    21 / 3576 (0.59%)
    18 / 3581 (0.50%)
    35 / 3576 (0.98%)
    35 / 3581 (0.98%)
         occurrences all number
    25
    18
    39
    35
    Hepatitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hepatobiliary disease
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Hepatomegaly
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Hydrocholecystis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Jaundice
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    2
    2
    Liver disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    4
    3
    Pneumobilia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Portal hypertension
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    2
    Investigations
    Abdominal bruit
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    16 / 3576 (0.45%)
    8 / 3581 (0.22%)
         occurrences all number
    7
    4
    16
    8
    Amylase increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Antinuclear antibody increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Aortic bruit
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Arterial bruit
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arteriogram coronary abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    9 / 3576 (0.25%)
    3 / 3581 (0.08%)
    16 / 3576 (0.45%)
    7 / 3581 (0.20%)
         occurrences all number
    9
    3
    17
    7
    Aspiration bronchial
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacterial test
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Beta 2 microglobulin increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood albumin decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    4
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Blood calcium increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Blood chloride decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    2
    1
    5
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Blood folate decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    1
    4
    Blood glucose increased
         subjects affected / exposed
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    0
    6
    6
    Blood immunoglobulin G increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Blood iron decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Blood iron increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood parathyroid hormone increased
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Blood potassium increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Blood pressure decreased
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Blood pressure increased
         subjects affected / exposed
    21 / 3576 (0.59%)
    13 / 3581 (0.36%)
    39 / 3576 (1.09%)
    25 / 3581 (0.70%)
         occurrences all number
    21
    13
    42
    25
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Blood sodium decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood urea increased
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    5
    1
    Blood uric acid increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    1
    2
    Body height abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Body height decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    2 / 3576 (0.06%)
    9 / 3581 (0.25%)
         occurrences all number
    1
    4
    2
    9
    Body mass index increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    0
    3
    Bone density decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Brain scan abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Breath sounds abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Cardiac murmur
         subjects affected / exposed
    9 / 3576 (0.25%)
    2 / 3581 (0.06%)
    16 / 3576 (0.45%)
    12 / 3581 (0.34%)
         occurrences all number
    9
    2
    16
    12
    Carotid bruit
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Carotid pulse abnormal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Carotid pulse increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Chest X-ray abnormal
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    8 / 3576 (0.22%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    1
    9
    5
    Coagulation time prolonged
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Computerised tomogram head abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Creatinine renal clearance decreased
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Creatinine renal clearance increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Electrocardiogram Q wave abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Eosinophil count increased
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Faecal calprotectin increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Glomerular filtration rate abnormal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Grip strength decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    4
    1
    Heart rate increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Heart rate irregular
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    2
    3
    Helicobacter test positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Hepatic enzyme abnormal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    5
    1
    5
    2
    Hepatitis A antibody positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hepatitis B surface antigen positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hepatitis C virus test positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hepatobiliary scan abnormal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Human epidermal growth factor receptor decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Intraocular pressure increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Liver function test abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    2
    2
    Liver function test increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Low density lipoprotein increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Lymphocyte morphology abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mammogram abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Monocyte count increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Neutrophil count increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Occult blood
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Occult blood positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    2
    1
    4
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Platelet count increased
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    2
    3
    Protein total increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary arterial pressure increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Reticulocyte count decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rheumatoid factor positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thyroid function test abnormal
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Transaminases increased
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    10 / 3576 (0.28%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    2
    11
    5
    Tuberculin test positive
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Ultrasound liver abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary system X-ray
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urine output decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Valsalva maneuver
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vitamin B12 increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    12 / 3576 (0.34%)
    23 / 3581 (0.64%)
    45 / 3576 (1.26%)
    54 / 3581 (1.51%)
         occurrences all number
    12
    24
    46
    57
    Weight increased
         subjects affected / exposed
    11 / 3576 (0.31%)
    7 / 3581 (0.20%)
    15 / 3576 (0.42%)
    11 / 3581 (0.31%)
         occurrences all number
    11
    7
    15
    11
    White blood cell count decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    3
    White blood cell count increased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    X-ray abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Accident at work
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Accidental exposure to product
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Anaemia postoperative
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    3
    4
    6
    Animal bite
         subjects affected / exposed
    10 / 3576 (0.28%)
    4 / 3581 (0.11%)
    18 / 3576 (0.50%)
    7 / 3581 (0.20%)
         occurrences all number
    11
    4
    20
    7
    Animal scratch
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Arthropod bite
         subjects affected / exposed
    13 / 3576 (0.36%)
    18 / 3581 (0.50%)
    17 / 3576 (0.48%)
    28 / 3581 (0.78%)
         occurrences all number
    14
    19
    19
    30
    Arthropod sting
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    9 / 3581 (0.25%)
         occurrences all number
    0
    2
    1
    11
    Back injury
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    7 / 3576 (0.20%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    1
    7
    2
    Bladder injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Bone contusion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    3
    1
    Bone fissure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Brain contusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Breast injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Burns first degree
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Burns second degree
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    4
    3
    Buttock injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cartilage injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Cataract operation complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    3
    Chemical burn of skin
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Chest crushing
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest injury
         subjects affected / exposed
    15 / 3576 (0.42%)
    5 / 3581 (0.14%)
    29 / 3576 (0.81%)
    11 / 3581 (0.31%)
         occurrences all number
    16
    5
    30
    11
    Clavicle fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    2
    3
    5
    Concussion
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Conjunctival laceration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    122 / 3576 (3.41%)
    102 / 3581 (2.85%)
    204 / 3576 (5.70%)
    179 / 3581 (5.00%)
         occurrences all number
    151
    119
    270
    212
    Corneal abrasion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Craniocerebral injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    3
    4
    4
    Crushing injury of trunk
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Deafness traumatic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epicondylitis
         subjects affected / exposed
    10 / 3576 (0.28%)
    9 / 3581 (0.25%)
    17 / 3576 (0.48%)
    12 / 3581 (0.34%)
         occurrences all number
    10
    9
    17
    13
    Eschar
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    2
    Excoriation
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    7 / 3576 (0.20%)
    11 / 3581 (0.31%)
         occurrences all number
    2
    5
    9
    11
    Exposure to communicable disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    3
    Eye burns
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eye contusion
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    8 / 3576 (0.22%)
    4 / 3581 (0.11%)
         occurrences all number
    5
    2
    8
    5
    Eye injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Eye operation complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Eyelid injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Face injury
         subjects affected / exposed
    10 / 3576 (0.28%)
    5 / 3581 (0.14%)
    13 / 3576 (0.36%)
    9 / 3581 (0.25%)
         occurrences all number
    10
    6
    14
    10
    Facial bones fracture
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    0
    4
    2
    Fall
         subjects affected / exposed
    319 / 3576 (8.92%)
    255 / 3581 (7.12%)
    539 / 3576 (15.07%)
    484 / 3581 (13.52%)
         occurrences all number
    378
    321
    801
    676
    Femoral neck fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Femur fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fibula fracture
         subjects affected / exposed
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
    12 / 3576 (0.34%)
    10 / 3581 (0.28%)
         occurrences all number
    6
    4
    13
    10
    Foot fracture
         subjects affected / exposed
    13 / 3576 (0.36%)
    11 / 3581 (0.31%)
    28 / 3576 (0.78%)
    22 / 3581 (0.61%)
         occurrences all number
    13
    11
    28
    23
    Foreign body
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Foreign body in eye
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fractured ischium
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Gastrointestinal injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gingival injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Glaucoma traumatic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Graft complication
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hand fracture
         subjects affected / exposed
    13 / 3576 (0.36%)
    4 / 3581 (0.11%)
    25 / 3576 (0.70%)
    9 / 3581 (0.25%)
         occurrences all number
    14
    4
    27
    9
    Head injury
         subjects affected / exposed
    14 / 3576 (0.39%)
    13 / 3581 (0.36%)
    24 / 3576 (0.67%)
    22 / 3581 (0.61%)
         occurrences all number
    14
    13
    24
    24
    Heat exhaustion
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Heat illness
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    3
    Humerus fracture
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
         occurrences all number
    2
    5
    9
    9
    Hypobarism
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Iliotibial band syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Incision site pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Incisional hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury
         subjects affected / exposed
    18 / 3576 (0.50%)
    14 / 3581 (0.39%)
    22 / 3576 (0.62%)
    22 / 3581 (0.61%)
         occurrences all number
    18
    15
    23
    23
    Injury corneal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint dislocation
         subjects affected / exposed
    8 / 3576 (0.22%)
    5 / 3581 (0.14%)
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
         occurrences all number
    9
    8
    13
    18
    Joint injury
         subjects affected / exposed
    60 / 3576 (1.68%)
    44 / 3581 (1.23%)
    98 / 3576 (2.74%)
    75 / 3581 (2.09%)
         occurrences all number
    67
    47
    115
    87
    Laceration
         subjects affected / exposed
    17 / 3576 (0.48%)
    11 / 3581 (0.31%)
    32 / 3576 (0.89%)
    28 / 3581 (0.78%)
         occurrences all number
    17
    11
    33
    32
    Ligament injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Ligament rupture
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Ligament sprain
         subjects affected / exposed
    38 / 3576 (1.06%)
    30 / 3581 (0.84%)
    60 / 3576 (1.68%)
    55 / 3581 (1.54%)
         occurrences all number
    42
    33
    72
    59
    Limb injury
         subjects affected / exposed
    54 / 3576 (1.51%)
    65 / 3581 (1.82%)
    97 / 3576 (2.71%)
    106 / 3581 (2.96%)
         occurrences all number
    59
    71
    104
    121
    Lip injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    2
    3
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    1
    2
    3
    Mallet finger
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Meniscus injury
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    12 / 3576 (0.34%)
    6 / 3581 (0.17%)
         occurrences all number
    8
    1
    15
    6
    Mouth injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Multiple injuries
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    3
    1
    Muscle injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    1
    3
    6
    Muscle rupture
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Muscle strain
         subjects affected / exposed
    13 / 3576 (0.36%)
    12 / 3581 (0.34%)
    23 / 3576 (0.64%)
    17 / 3581 (0.47%)
         occurrences all number
    13
    12
    24
    18
    Musculoskeletal injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Nail injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    4
    0
    4
    Nasal injury
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    5
    3
    6
    3
    Neck injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Nerve injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Overdose
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    3
    1
    4
    Patella fracture
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    4
    2
    Perineal injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Periorbital haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    0
    3
    3
    Periorbital haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Perirenal haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Peroneal nerve injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Post procedural complication
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Post procedural contusion
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Post procedural fistula
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    3
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    2
    2
    Post procedural hypothyroidism
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Post procedural inflammation
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Post procedural swelling
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Post-traumatic pain
         subjects affected / exposed
    13 / 3576 (0.36%)
    9 / 3581 (0.25%)
    17 / 3576 (0.48%)
    10 / 3581 (0.28%)
         occurrences all number
    14
    10
    18
    11
    Postoperative hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Postoperative ileus
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Postoperative wound complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Postpericardiotomy syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Procedural complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Procedural dizziness
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Procedural headache
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Procedural pain
         subjects affected / exposed
    27 / 3576 (0.76%)
    22 / 3581 (0.61%)
    40 / 3576 (1.12%)
    34 / 3581 (0.95%)
         occurrences all number
    27
    23
    43
    36
    Procedural pneumothorax
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pubis fracture
         subjects affected / exposed
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    4
    0
    4
    0
    Pulmonary contusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Radiation associated pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Radiation proctitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Radiation skin injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Radius fracture
         subjects affected / exposed
    25 / 3576 (0.70%)
    22 / 3581 (0.61%)
    52 / 3576 (1.45%)
    52 / 3581 (1.45%)
         occurrences all number
    25
    22
    53
    53
    Rib fracture
         subjects affected / exposed
    12 / 3576 (0.34%)
    3 / 3581 (0.08%)
    21 / 3576 (0.59%)
    6 / 3581 (0.17%)
         occurrences all number
    12
    3
    22
    6
    Road traffic accident
         subjects affected / exposed
    10 / 3576 (0.28%)
    12 / 3581 (0.34%)
    14 / 3576 (0.39%)
    16 / 3581 (0.45%)
         occurrences all number
    10
    13
    14
    17
    Scar
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Scratch
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    5
    1
    5
    1
    Seroma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skeletal injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    3
    1
    Skin abrasion
         subjects affected / exposed
    15 / 3576 (0.42%)
    11 / 3581 (0.31%)
    23 / 3576 (0.64%)
    23 / 3581 (0.64%)
         occurrences all number
    16
    11
    26
    26
    Skin injury
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    2
    4
    2
    Skin wound
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Skull fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Soft tissue injury
         subjects affected / exposed
    37 / 3576 (1.03%)
    28 / 3581 (0.78%)
    47 / 3576 (1.31%)
    32 / 3581 (0.89%)
         occurrences all number
    39
    35
    53
    40
    Spinal column injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    5
    5
    Spinal compression fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Spinal fracture
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    4
    2
    Splinter
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Stab wound
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Sternal fracture
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Sternal injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Subdural haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Sunburn
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Suture related complication
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Synovial rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tendon injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    3
    1
    Tendon rupture
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    4
    7
    7
    Thermal burn
         subjects affected / exposed
    11 / 3576 (0.31%)
    9 / 3581 (0.25%)
    23 / 3576 (0.64%)
    14 / 3581 (0.39%)
         occurrences all number
    11
    9
    24
    14
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Tibia fracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Tongue injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    28 / 3576 (0.78%)
    31 / 3581 (0.87%)
    54 / 3576 (1.51%)
    61 / 3581 (1.70%)
         occurrences all number
    29
    34
    62
    71
    Tooth injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    1
    6
    5
    Toxicity to various agents
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Traumatic haematoma
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    5
    3
    5
    3
    Traumatic haemorrhage
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    5
    0
    Traumatic lung injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Traumatic ulcer
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Ulna fracture
         subjects affected / exposed
    8 / 3576 (0.22%)
    5 / 3581 (0.14%)
    20 / 3576 (0.56%)
    15 / 3581 (0.42%)
         occurrences all number
    8
    5
    21
    16
    Ulnar nerve injury
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Vaccination complication
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Vascular injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Wound
         subjects affected / exposed
    10 / 3576 (0.28%)
    20 / 3581 (0.56%)
    30 / 3576 (0.84%)
    35 / 3581 (0.98%)
         occurrences all number
    10
    21
    30
    38
    Wound secretion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Wrist fracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Congenital, familial and genetic disorders
    Adenomatous polyposis coli
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Arteriovenous malformation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bartter's syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Birth mark
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Cortical dysplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Dermoid cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dolichocolon
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Epidermolysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Extrarenal pelvis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Fibrous dysplasia of bone
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorder congenital
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Intracranial lipoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Polycystic liver disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Porokeratosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Protein C deficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Renal hypoplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Sacralisation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spina bifida
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spine malformation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Syringomyelia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Type IIa hyperlipidaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vertebral artery hypoplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Angina pectoris
         subjects affected / exposed
    13 / 3576 (0.36%)
    7 / 3581 (0.20%)
    23 / 3576 (0.64%)
    17 / 3581 (0.47%)
         occurrences all number
    14
    10
    24
    20
    Angina unstable
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Aortic valve calcification
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Aortic valve disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Aortic valve incompetence
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    17 / 3576 (0.48%)
    15 / 3581 (0.42%)
         occurrences all number
    7
    7
    17
    15
    Aortic valve sclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    3
    Aortic valve stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    4
    1
    Arrhythmia
         subjects affected / exposed
    10 / 3576 (0.28%)
    8 / 3581 (0.22%)
    18 / 3576 (0.50%)
    17 / 3581 (0.47%)
         occurrences all number
    10
    8
    18
    17
    Arrhythmia supraventricular
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    0
    3
    2
    Arteriosclerosis coronary artery
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    4
    1
    Atrial fibrillation
         subjects affected / exposed
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
    34 / 3576 (0.95%)
    26 / 3581 (0.73%)
         occurrences all number
    15
    18
    38
    34
    Atrial flutter
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    2
    2
    Atrial tachycardia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Atrioventricular block first degree
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    6
    2
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Bradycardia
         subjects affected / exposed
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
    9 / 3576 (0.25%)
    20 / 3581 (0.56%)
         occurrences all number
    5
    7
    9
    21
    Bundle branch block left
         subjects affected / exposed
    0 / 3576 (0.00%)
    6 / 3581 (0.17%)
    5 / 3576 (0.14%)
    12 / 3581 (0.34%)
         occurrences all number
    0
    7
    5
    13
    Bundle branch block right
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    10 / 3576 (0.28%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    2
    10
    4
    Cardiac aneurysm
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Cardiac disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    0
    3
    Cardiac failure
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    11 / 3576 (0.31%)
    16 / 3581 (0.45%)
         occurrences all number
    7
    7
    12
    16
    Cardiac failure acute
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cardiac failure chronic
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
         occurrences all number
    3
    4
    9
    9
    Cardiac failure congestive
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
         occurrences all number
    5
    1
    6
    5
    Cardiac hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Cardiac septal hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    1
    3
    Cardiac valve disease
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    4
    2
    5
    Cardiac valve sclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Cardiac ventricular disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cardiomegaly
         subjects affected / exposed
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
    7 / 3576 (0.20%)
    11 / 3581 (0.31%)
         occurrences all number
    5
    6
    7
    11
    Cardiomyopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Cardiovascular disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conduction disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Coronary artery disease
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    14 / 3576 (0.39%)
    11 / 3581 (0.31%)
         occurrences all number
    7
    7
    15
    11
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    2
    3
    Coronary artery occlusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cyanosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Degenerative aortic valve disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Degenerative mitral valve disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Diastolic dysfunction
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    2
    4
    Dilatation atrial
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    3
    1
    5
    Extrasystoles
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    2
    7
    3
    Heart valve calcification
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Heart valve incompetence
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    9 / 3581 (0.25%)
         occurrences all number
    3
    3
    7
    10
    Hypertensive cardiomegaly
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    2
    Hypertensive cardiomyopathy
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    4
    1
    Hypertensive heart disease
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    4
    4
    6
    Intracardiac thrombus
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    0
    2
    3
    Left atrial dilatation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    3
    1
    Left atrial enlargement
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    2
    1
    Left atrial hypertrophy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    5
    3
    Left ventricular failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    4
    4
    5
    Low cardiac output syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Mitral valve calcification
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mitral valve disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Mitral valve incompetence
         subjects affected / exposed
    8 / 3576 (0.22%)
    11 / 3581 (0.31%)
    27 / 3576 (0.76%)
    28 / 3581 (0.78%)
         occurrences all number
    8
    11
    28
    28
    Mitral valve prolapse
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    2
    3
    Mitral valve sclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    0
    3
    Mitral valve stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Myocardial infarction
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Myocardial ischaemia
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    12 / 3581 (0.34%)
         occurrences all number
    2
    4
    9
    12
    Palpitations
         subjects affected / exposed
    27 / 3576 (0.76%)
    24 / 3581 (0.67%)
    35 / 3576 (0.98%)
    35 / 3581 (0.98%)
         occurrences all number
    27
    24
    36
    36
    Pericardial effusion
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Pericarditis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary valve incompetence
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Right atrial enlargement
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Right ventricular dysfunction
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Right ventricular enlargement
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Right ventricular hypertrophy
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Sinus arrhythmia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Sinus bradycardia
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
         occurrences all number
    2
    5
    5
    7
    Sinus node dysfunction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    3
    0
    4
    Supraventricular extrasystoles
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    4
    9
    7
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    2
    2
    5
    Systolic dysfunction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Tachycardia
         subjects affected / exposed
    9 / 3576 (0.25%)
    12 / 3581 (0.34%)
    16 / 3576 (0.45%)
    18 / 3581 (0.50%)
         occurrences all number
    10
    15
    19
    22
    Tachycardia paroxysmal
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    2
    Tricuspid valve incompetence
         subjects affected / exposed
    4 / 3576 (0.11%)
    9 / 3581 (0.25%)
    20 / 3576 (0.56%)
    22 / 3581 (0.61%)
         occurrences all number
    4
    9
    20
    22
    Tricuspid valve stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    3
    2
    Ventricular extrasystoles
         subjects affected / exposed
    4 / 3576 (0.11%)
    7 / 3581 (0.20%)
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
         occurrences all number
    4
    7
    9
    9
    Ventricular hypertrophy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Ventricular hypokinesia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Nervous system disorders
    Acoustic neuritis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Akathisia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Altered state of consciousness
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Amnesia
         subjects affected / exposed
    6 / 3576 (0.17%)
    10 / 3581 (0.28%)
    9 / 3576 (0.25%)
    15 / 3581 (0.42%)
         occurrences all number
    7
    10
    10
    15
    Aphonia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Arachnoid cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Balance disorder
         subjects affected / exposed
    7 / 3576 (0.20%)
    10 / 3581 (0.28%)
    8 / 3576 (0.22%)
    13 / 3581 (0.36%)
         occurrences all number
    7
    11
    9
    14
    Brain injury
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Burning feet syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Burning sensation
         subjects affected / exposed
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
    9 / 3576 (0.25%)
    13 / 3581 (0.36%)
         occurrences all number
    6
    8
    9
    14
    Carotid arteriosclerosis
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    12 / 3576 (0.34%)
    8 / 3581 (0.22%)
         occurrences all number
    4
    4
    13
    8
    Carotid artery disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Carotid artery stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    7
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    13 / 3576 (0.36%)
    9 / 3581 (0.25%)
    27 / 3576 (0.76%)
    17 / 3581 (0.47%)
         occurrences all number
    16
    9
    33
    18
    Central nervous system lesion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cerebellar atrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Cerebellar syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cerebral arteriosclerosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    2
    2
    6
    Cerebral artery stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebral atrophy
         subjects affected / exposed
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    10 / 3581 (0.28%)
         occurrences all number
    4
    5
    6
    10
    Cerebral calcification
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cerebral disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Cerebral haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    2
    2
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Cerebral infarction
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Cerebral ischaemia
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    8 / 3576 (0.22%)
    8 / 3581 (0.22%)
         occurrences all number
    4
    4
    9
    9
    Cerebral microangiopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    1
    0
    4
    Cerebrosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    1
    2
    Cerebrovascular disorder
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    11 / 3576 (0.31%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    4
    12
    7
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Cervical myelopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cervical radiculopathy
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
         occurrences all number
    3
    2
    7
    7
    Cervicobrachial syndrome
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    2
    7
    5
    Cognitive disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
         occurrences all number
    1
    0
    4
    6
    Complex regional pain syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Cranial nerve disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dementia
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    1
    6
    5
    Dementia Alzheimer's type
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    9 / 3576 (0.25%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    3
    9
    5
    Demyelination
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Diabetic neuropathy
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    3
    8
    7
    Dizziness
         subjects affected / exposed
    158 / 3576 (4.42%)
    154 / 3581 (4.30%)
    216 / 3576 (6.04%)
    228 / 3581 (6.37%)
         occurrences all number
    181
    174
    259
    264
    Dizziness exertional
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Dizziness postural
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    3
    4
    7
    Drooling
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Drug withdrawal headache
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dysaesthesia
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    4
    2
    5
    Dysarthria
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
    10 / 3576 (0.28%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    6
    11
    8
    Dyskinesia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Dysphonia psychogenic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Encephalopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Epilepsy
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    4
    1
    Essential tremor
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Facial neuralgia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Facial paralysis
         subjects affected / exposed
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
    14 / 3576 (0.39%)
    8 / 3581 (0.22%)
         occurrences all number
    6
    4
    14
    9
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Head discomfort
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    2
    2
    Headache
         subjects affected / exposed
    206 / 3576 (5.76%)
    235 / 3581 (6.56%)
    270 / 3576 (7.55%)
    293 / 3581 (8.18%)
         occurrences all number
    240
    270
    327
    352
    Hemianopia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Hemianopia heteronymous
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hemiparesis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    3
    2
    Hydrocephalus
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Hyperaesthesia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypersomnia
         subjects affected / exposed
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    4
    0
    4
    0
    Hypoaesthesia
         subjects affected / exposed
    20 / 3576 (0.56%)
    36 / 3581 (1.01%)
    31 / 3576 (0.87%)
    48 / 3581 (1.34%)
         occurrences all number
    22
    43
    34
    57
    Hyposmia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypotonia
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Intercostal neuralgia
         subjects affected / exposed
    10 / 3576 (0.28%)
    4 / 3581 (0.11%)
    11 / 3576 (0.31%)
    6 / 3581 (0.17%)
         occurrences all number
    11
    4
    13
    6
    Intracranial aneurysm
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Ischaemic stroke
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Lacunar infarction
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    0
    2
    2
    Lethargy
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    0
    4
    2
    Leukoencephalomyelitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Leukoencephalopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    4
    3
    Loss of consciousness
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    2
    7
    4
    Lumbar radiculopathy
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    8 / 3576 (0.22%)
    10 / 3581 (0.28%)
         occurrences all number
    3
    5
    9
    14
    Lumbosacral radiculopathy
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Memory impairment
         subjects affected / exposed
    11 / 3576 (0.31%)
    10 / 3581 (0.28%)
    27 / 3576 (0.76%)
    26 / 3581 (0.73%)
         occurrences all number
    11
    10
    27
    27
    Migraine
         subjects affected / exposed
    12 / 3576 (0.34%)
    12 / 3581 (0.34%)
    17 / 3576 (0.48%)
    16 / 3581 (0.45%)
         occurrences all number
    16
    13
    24
    17
    Migraine with aura
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    2
    2
    Mononeuropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Monoparesis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    3
    Morton's neuralgia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Movement disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Multiple sclerosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Multiple sclerosis relapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Muscle contractions involuntary
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    3
    2
    Myasthenia gravis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nerve compression
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    3
    4
    Nerve root compression
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    3
    Nervous system disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Neuralgia
         subjects affected / exposed
    8 / 3576 (0.22%)
    11 / 3581 (0.31%)
    10 / 3576 (0.28%)
    15 / 3581 (0.42%)
         occurrences all number
    8
    11
    11
    15
    Neuritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Neuropathy peripheral
         subjects affected / exposed
    9 / 3576 (0.25%)
    6 / 3581 (0.17%)
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
         occurrences all number
    9
    6
    13
    13
    Noninfective encephalitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Occipital neuralgia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Optic neuritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Osmotic demyelination syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    61 / 3576 (1.71%)
    72 / 3581 (2.01%)
    86 / 3576 (2.40%)
    87 / 3581 (2.43%)
         occurrences all number
    65
    83
    96
    101
    Paraparesis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Parkinson's disease
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    10 / 3581 (0.28%)
         occurrences all number
    4
    4
    9
    10
    Parkinsonism
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Parosmia
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    5
    2
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Peripheral nerve palsy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Peripheral nerve paresis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Polyneuropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    6 / 3581 (0.17%)
         occurrences all number
    0
    2
    1
    6
    Poor quality sleep
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Post herpetic neuralgia
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    10 / 3576 (0.28%)
    10 / 3581 (0.28%)
         occurrences all number
    4
    4
    10
    10
    Post polio syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Post-traumatic epilepsy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Post-traumatic headache
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Precerebral arteriosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Presyncope
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    2
    3
    Pseudoradicular syndrome
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Radicular pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    6 / 3581 (0.17%)
         occurrences all number
    1
    3
    2
    6
    Radicular syndrome
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    1
    2
    4
    Radiculopathy
         subjects affected / exposed
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
    7 / 3576 (0.20%)
    8 / 3581 (0.22%)
         occurrences all number
    5
    9
    9
    11
    Restless legs syndrome
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
         occurrences all number
    3
    4
    5
    7
    Sciatic nerve neuropathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sciatica
         subjects affected / exposed
    42 / 3576 (1.17%)
    44 / 3581 (1.23%)
    87 / 3576 (2.43%)
    94 / 3581 (2.62%)
         occurrences all number
    43
    50
    100
    110
    Sedation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Seizure
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Senile dementia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sinus headache
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Somnolence
         subjects affected / exposed
    13 / 3576 (0.36%)
    11 / 3581 (0.31%)
    16 / 3576 (0.45%)
    13 / 3581 (0.36%)
         occurrences all number
    13
    11
    19
    13
    Speech disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    2
    2
    Spinal cord disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Spinal meningeal cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Syncope
         subjects affected / exposed
    30 / 3576 (0.84%)
    20 / 3581 (0.56%)
    43 / 3576 (1.20%)
    41 / 3581 (1.14%)
         occurrences all number
    31
    21
    49
    44
    Tarsal tunnel syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Tension headache
         subjects affected / exposed
    12 / 3576 (0.34%)
    14 / 3581 (0.39%)
    16 / 3576 (0.45%)
    16 / 3581 (0.45%)
         occurrences all number
    12
    14
    16
    18
    Tongue biting
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    5
    4
    Tremor
         subjects affected / exposed
    9 / 3576 (0.25%)
    12 / 3581 (0.34%)
    14 / 3576 (0.39%)
    17 / 3581 (0.47%)
         occurrences all number
    10
    13
    15
    20
    Trigeminal nerve paresis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Trigeminal neuritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    1
    2
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vascular dementia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Vascular encephalopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    2
    3
    Vertigo CNS origin
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Visual field defect
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Vocal cord paralysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    White matter lesion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    57 / 3576 (1.59%)
    36 / 3581 (1.01%)
    124 / 3576 (3.47%)
    99 / 3581 (2.76%)
         occurrences all number
    58
    39
    135
    111
    Anaemia folate deficiency
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anaemia megaloblastic
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Bandaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Basophilia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Blood disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bone marrow failure
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Coagulopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eosinophilia
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    5
    3
    6
    6
    Febrile neutropenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    0
    5
    Granulocytosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhagic anaemia
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Hypergammaglobulinaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Hyperglobulinaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hypochromic anaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Immune thrombocytopenic purpura
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Increased tendency to bruise
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Iron deficiency anaemia
         subjects affected / exposed
    14 / 3576 (0.39%)
    12 / 3581 (0.34%)
    16 / 3576 (0.45%)
    24 / 3581 (0.67%)
         occurrences all number
    14
    12
    16
    26
    Leukocytosis
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    10 / 3576 (0.28%)
    9 / 3581 (0.25%)
         occurrences all number
    3
    3
    10
    9
    Leukopenia
         subjects affected / exposed
    13 / 3576 (0.36%)
    14 / 3581 (0.39%)
    21 / 3576 (0.59%)
    24 / 3581 (0.67%)
         occurrences all number
    13
    16
    22
    27
    Lymph node calcification
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Lymph node pain
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    2
    1
    4
    Lymphadenopathy
         subjects affected / exposed
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
    8 / 3576 (0.22%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    3
    9
    9
    Lymphocytosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    1
    5
    Lymphopenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Microcytic anaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    1
    2
    Nephrogenic anaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Neutropenia
         subjects affected / exposed
    12 / 3576 (0.34%)
    8 / 3581 (0.22%)
    16 / 3576 (0.45%)
    17 / 3581 (0.47%)
         occurrences all number
    12
    9
    16
    22
    Neutrophilia
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    0
    1
    5
    Pancytopenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Polycythaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sideroblastic anaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Splenomegaly
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
    15 / 3576 (0.42%)
    11 / 3581 (0.31%)
         occurrences all number
    6
    4
    17
    11
    Thrombocytosis
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
         occurrences all number
    4
    4
    9
    9
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    3
    Auditory disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Cerumen impaction
         subjects affected / exposed
    10 / 3576 (0.28%)
    10 / 3581 (0.28%)
    17 / 3576 (0.48%)
    20 / 3581 (0.56%)
         occurrences all number
    10
    10
    17
    20
    Conductive deafness
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    2
    3
    Deafness
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    4
    1
    Deafness bilateral
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    7 / 3576 (0.20%)
    6 / 3581 (0.17%)
         occurrences all number
    4
    4
    7
    6
    Deafness neurosensory
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    3
    4
    3
    Deafness unilateral
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    3
    3
    5
    Dysacusis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Ear congestion
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    2
    3
    3
    Ear discomfort
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Ear disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Ear pain
         subjects affected / exposed
    15 / 3576 (0.42%)
    14 / 3581 (0.39%)
    24 / 3576 (0.67%)
    22 / 3581 (0.61%)
         occurrences all number
    15
    15
    27
    23
    Ear pruritus
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    2
    3
    3
    Excessive cerumen production
         subjects affected / exposed
    3 / 3576 (0.08%)
    8 / 3581 (0.22%)
    6 / 3576 (0.17%)
    11 / 3581 (0.31%)
         occurrences all number
    3
    8
    6
    11
    External ear disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    External ear inflammation
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    4
    2
    Hypoacusis
         subjects affected / exposed
    16 / 3576 (0.45%)
    12 / 3581 (0.34%)
    21 / 3576 (0.59%)
    21 / 3581 (0.59%)
         occurrences all number
    16
    12
    21
    21
    Inner ear disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Meniere's disease
         subjects affected / exposed
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
    9 / 3576 (0.25%)
    4 / 3581 (0.11%)
         occurrences all number
    6
    2
    9
    6
    Middle ear effusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Middle ear inflammation
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Mixed deafness
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    2
    3
    Motion sickness
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    4
    1
    4
    Neurosensory hypoacusis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Otorrhoea
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Otosclerosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Presbyacusis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Sudden hearing loss
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Tinnitus
         subjects affected / exposed
    29 / 3576 (0.81%)
    28 / 3581 (0.78%)
    42 / 3576 (1.17%)
    38 / 3581 (1.06%)
         occurrences all number
    30
    28
    43
    39
    Tympanic membrane disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tympanic membrane perforation
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    4
    6
    4
    Tympanosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vertigo
         subjects affected / exposed
    80 / 3576 (2.24%)
    62 / 3581 (1.73%)
    117 / 3576 (3.27%)
    113 / 3581 (3.16%)
         occurrences all number
    92
    69
    140
    133
    Vertigo labyrinthine
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Vertigo positional
         subjects affected / exposed
    8 / 3576 (0.22%)
    6 / 3581 (0.17%)
    15 / 3576 (0.42%)
    9 / 3581 (0.25%)
         occurrences all number
    10
    6
    17
    9
    Vestibular ataxia
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    4
    1
    Vestibular disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    3
    2
    Amaurosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Amblyopia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Angle closure glaucoma
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    0
    5
    1
    Arteriosclerotic retinopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Asthenopia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    1
    1
    4
    Astigmatism
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Blepharitis
         subjects affected / exposed
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
    10 / 3576 (0.28%)
    12 / 3581 (0.34%)
         occurrences all number
    7
    6
    11
    12
    Blepharitis allergic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Blepharochalasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Blindness transient
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blindness unilateral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Cataract
         subjects affected / exposed
    49 / 3576 (1.37%)
    66 / 3581 (1.84%)
    127 / 3576 (3.55%)
    152 / 3581 (4.24%)
         occurrences all number
    60
    84
    151
    191
    Cataract diabetic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cataract nuclear
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Chalazion
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    1
    5
    3
    Chorioretinopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    5
    Conjunctival haemorrhage
         subjects affected / exposed
    4 / 3576 (0.11%)
    10 / 3581 (0.28%)
    9 / 3576 (0.25%)
    18 / 3581 (0.50%)
         occurrences all number
    4
    10
    9
    20
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    1
    2
    Conjunctival irritation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Conjunctival ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    17 / 3576 (0.48%)
    15 / 3581 (0.42%)
    23 / 3576 (0.64%)
    23 / 3581 (0.64%)
         occurrences all number
    17
    15
    23
    23
    Conjunctivochalasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Corneal degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Corneal leukoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    4
    2
    4
    Diabetic retinopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    3
    1
    Diplopia
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    4
    3
    Dry age-related macular degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry eye
         subjects affected / exposed
    10 / 3576 (0.28%)
    15 / 3581 (0.42%)
    20 / 3576 (0.56%)
    24 / 3581 (0.67%)
         occurrences all number
    11
    15
    21
    24
    Ectropion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Entropion
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Erythema of eyelid
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Exfoliation glaucoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Exophthalmos
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Eye allergy
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    5
    2
    Eye discharge
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Eye disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Eye haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    3
    4
    Eye inflammation
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    3
    3
    Eye irritation
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    1
    4
    5
    Eye movement disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Eye pain
         subjects affected / exposed
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
    8 / 3576 (0.22%)
    10 / 3581 (0.28%)
         occurrences all number
    5
    9
    8
    12
    Eye pruritus
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    5
    4
    5
    Eye swelling
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Eyelid disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Eyelid haematoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Eyelid oedema
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
         occurrences all number
    2
    4
    3
    7
    Eyelid ptosis
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    8
    3
    Eyelid rash
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Eyelids pruritus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    1
    3
    Glaucoma
         subjects affected / exposed
    8 / 3576 (0.22%)
    18 / 3581 (0.50%)
    29 / 3576 (0.81%)
    40 / 3581 (1.12%)
         occurrences all number
    8
    18
    29
    42
    Hypermetropia
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Iritis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Keratitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    1
    1
    5
    Keratopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Lacrimal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    9 / 3576 (0.25%)
    11 / 3581 (0.31%)
         occurrences all number
    7
    7
    9
    11
    Lenticular opacities
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Macular degeneration
         subjects affected / exposed
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
    13 / 3576 (0.36%)
    12 / 3581 (0.34%)
         occurrences all number
    7
    8
    14
    12
    Macular fibrosis
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    4
    2
    Macular hole
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Macular oedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Maculopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Mydriasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Ocular discomfort
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Ocular hyperaemia
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    3
    5
    6
    5
    Open angle glaucoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Photopsia
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    4
    1
    Posterior capsule opacification
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presbyopia
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    3
    3
    Pterygium
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    0
    3
    3
    Refraction disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    4
    1
    4
    Retinal degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Retinal detachment
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    1
    1
    5
    Retinal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    1
    3
    Retinal dystrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    1
    2
    Retinal tear
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    2
    2
    Retinal vascular disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Retinal vascular thrombosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Retinal vein occlusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Retinal vein thrombosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Retinopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    4
    1
    Scleral haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Strabismus
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    1
    0
    3
    Sudden visual loss
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Trichiasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Uveitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Vision blurred
         subjects affected / exposed
    14 / 3576 (0.39%)
    8 / 3581 (0.22%)
    19 / 3576 (0.53%)
    13 / 3581 (0.36%)
         occurrences all number
    14
    8
    20
    14
    Visual acuity reduced
         subjects affected / exposed
    9 / 3576 (0.25%)
    8 / 3581 (0.22%)
    14 / 3576 (0.39%)
    12 / 3581 (0.34%)
         occurrences all number
    9
    8
    14
    12
    Visual acuity reduced transiently
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Visual impairment
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    11 / 3576 (0.31%)
    8 / 3581 (0.22%)
         occurrences all number
    8
    4
    12
    8
    Vitreous degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Vitreous detachment
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    4
    5
    Vitreous disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Vitreous floaters
         subjects affected / exposed
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
    7 / 3576 (0.20%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    4
    7
    6
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Xerophthalmia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Abdominal discomfort
         subjects affected / exposed
    11 / 3576 (0.31%)
    5 / 3581 (0.14%)
    16 / 3576 (0.45%)
    13 / 3581 (0.36%)
         occurrences all number
    12
    6
    18
    14
    Abdominal distension
         subjects affected / exposed
    28 / 3576 (0.78%)
    27 / 3581 (0.75%)
    36 / 3576 (1.01%)
    40 / 3581 (1.12%)
         occurrences all number
    32
    29
    43
    44
    Abdominal hernia
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    2
    4
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal mass
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Abdominal pain
         subjects affected / exposed
    75 / 3576 (2.10%)
    60 / 3581 (1.68%)
    114 / 3576 (3.19%)
    89 / 3581 (2.49%)
         occurrences all number
    82
    66
    127
    107
    Abdominal pain lower
         subjects affected / exposed
    15 / 3576 (0.42%)
    7 / 3581 (0.20%)
    21 / 3576 (0.59%)
    14 / 3581 (0.39%)
         occurrences all number
    16
    7
    22
    14
    Abdominal pain upper
         subjects affected / exposed
    96 / 3576 (2.68%)
    88 / 3581 (2.46%)
    124 / 3576 (3.47%)
    123 / 3581 (3.43%)
         occurrences all number
    103
    95
    137
    135
    Abdominal tenderness
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    0
    3
    2
    Abnormal faeces
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Acid peptic disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    1
    3
    4
    Amalgam tattoo
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Anal fistula
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Anal haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Anal incontinence
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    0
    6
    1
    Anal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    1
    2
    Anal pruritus
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    1
    7
    2
    Anorectal discomfort
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Anorectal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Anorectal varices
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Aphthous ulcer
         subjects affected / exposed
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
    6 / 3576 (0.17%)
    9 / 3581 (0.25%)
         occurrences all number
    4
    7
    6
    11
    Ascites
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Barrett's oesophagus
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Bowel movement irregularity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Breath odour
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Change of bowel habit
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Cheilitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Chronic gastritis
         subjects affected / exposed
    14 / 3576 (0.39%)
    21 / 3581 (0.59%)
    33 / 3576 (0.92%)
    37 / 3581 (1.03%)
         occurrences all number
    14
    21
    34
    39
    Coeliac disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    2
    2
    Colitis
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    8 / 3576 (0.22%)
    5 / 3581 (0.14%)
         occurrences all number
    5
    1
    9
    5
    Colitis ischaemic
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Colitis microscopic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Colitis psychogenic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Colitis ulcerative
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Colon dysplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Constipation
         subjects affected / exposed
    162 / 3576 (4.53%)
    138 / 3581 (3.85%)
    210 / 3576 (5.87%)
    189 / 3581 (5.28%)
         occurrences all number
    173
    150
    232
    216
    Crohn's disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Dental caries
         subjects affected / exposed
    50 / 3576 (1.40%)
    63 / 3581 (1.76%)
    99 / 3576 (2.77%)
    120 / 3581 (3.35%)
         occurrences all number
    53
    72
    114
    144
    Dental cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dental necrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Diaphragmatic hernia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    133 / 3576 (3.72%)
    111 / 3581 (3.10%)
    191 / 3576 (5.34%)
    182 / 3581 (5.08%)
         occurrences all number
    150
    130
    229
    217
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Diverticulum
         subjects affected / exposed
    11 / 3576 (0.31%)
    11 / 3581 (0.31%)
    19 / 3576 (0.53%)
    16 / 3581 (0.45%)
         occurrences all number
    11
    12
    19
    18
    Diverticulum intestinal
         subjects affected / exposed
    13 / 3576 (0.36%)
    10 / 3581 (0.28%)
    20 / 3576 (0.56%)
    24 / 3581 (0.67%)
         occurrences all number
    13
    11
    20
    25
    Diverticulum oesophageal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    14 / 3576 (0.39%)
    22 / 3581 (0.61%)
    20 / 3576 (0.56%)
    28 / 3581 (0.78%)
         occurrences all number
    14
    23
    21
    30
    Duodenal polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Duodenal ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Duodenitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    2
    4
    Duodenogastric reflux
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    1
    3
    Dyspepsia
         subjects affected / exposed
    59 / 3576 (1.65%)
    70 / 3581 (1.95%)
    98 / 3576 (2.74%)
    122 / 3581 (3.41%)
         occurrences all number
    65
    79
    107
    136
    Dysphagia
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    4
    9
    7
    Enamel anomaly
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Enteritis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Enterocolitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    0
    3
    Epigastric discomfort
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Erosive duodenitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    4
    2
    Erosive oesophagitis
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    2
    Eructation
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Faeces discoloured
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    1
    2
    Faeces hard
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Faeces pale
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Femoral hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Flatulence
         subjects affected / exposed
    14 / 3576 (0.39%)
    14 / 3581 (0.39%)
    19 / 3576 (0.53%)
    16 / 3581 (0.45%)
         occurrences all number
    15
    14
    21
    16
    Food poisoning
         subjects affected / exposed
    10 / 3576 (0.28%)
    10 / 3581 (0.28%)
    14 / 3576 (0.39%)
    13 / 3581 (0.36%)
         occurrences all number
    12
    11
    16
    14
    Frequent bowel movements
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Gastric antral vascular ectasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastric disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
         occurrences all number
    1
    4
    5
    8
    Gastric mucosa erythema
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Gastric mucosal hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastric polyps
         subjects affected / exposed
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
    13 / 3576 (0.36%)
    12 / 3581 (0.34%)
         occurrences all number
    3
    7
    15
    12
    Gastric ulcer
         subjects affected / exposed
    9 / 3576 (0.25%)
    1 / 3581 (0.03%)
    16 / 3576 (0.45%)
    5 / 3581 (0.14%)
         occurrences all number
    9
    1
    16
    5
    Gastric xanthoma
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastritis
         subjects affected / exposed
    102 / 3576 (2.85%)
    97 / 3581 (2.71%)
    166 / 3576 (4.64%)
    142 / 3581 (3.97%)
         occurrences all number
    114
    111
    195
    174
    Gastritis erosive
         subjects affected / exposed
    7 / 3576 (0.20%)
    10 / 3581 (0.28%)
    15 / 3576 (0.42%)
    19 / 3581 (0.53%)
         occurrences all number
    7
    10
    15
    19
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Gastroduodenal ulcer
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Gastroduodenitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    2
    3
    2
    Gastrointestinal angiodysplasia haemorrhagic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    2
    3
    5
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    2
    4
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Gastrointestinal mucosal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal pain
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    3
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    40 / 3576 (1.12%)
    40 / 3581 (1.12%)
    80 / 3576 (2.24%)
    78 / 3581 (2.18%)
         occurrences all number
    43
    44
    86
    84
    Gastrooesophageal sphincter insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Gingival bleeding
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    5
    3
    5
    Gingival disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    4
    4
    Gingival erosion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Gingival erythema
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Gingival hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gingival pain
         subjects affected / exposed
    7 / 3576 (0.20%)
    9 / 3581 (0.25%)
    7 / 3576 (0.20%)
    14 / 3581 (0.39%)
         occurrences all number
    7
    9
    7
    15
    Gingival recession
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Gingival swelling
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    3
    4
    Gingival ulceration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Glossitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    3
    3
    3
    Glossodynia
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    3
    0
    5
    Haematemesis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    0
    2
    Haematochezia
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    4
    5
    5
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Haemorrhoids
         subjects affected / exposed
    30 / 3576 (0.84%)
    23 / 3581 (0.64%)
    51 / 3576 (1.43%)
    44 / 3581 (1.23%)
         occurrences all number
    30
    23
    52
    44
    Hiatus hernia
         subjects affected / exposed
    20 / 3576 (0.56%)
    14 / 3581 (0.39%)
    41 / 3576 (1.15%)
    35 / 3581 (0.98%)
         occurrences all number
    20
    14
    41
    35
    Hyperchlorhydria
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    3
    2
    Ileal ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Ileus
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    0
    3
    Impaired gastric emptying
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Inguinal hernia
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    8 / 3576 (0.22%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    1
    8
    6
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    1
    1
    4
    Intestinal metaplasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    3
    1
    Intestinal obstruction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Intestinal polyp
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    1
    3
    Intra-abdominal haematoma
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Intussusception
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    26 / 3576 (0.73%)
    27 / 3581 (0.75%)
    47 / 3576 (1.31%)
    45 / 3581 (1.26%)
         occurrences all number
    28
    28
    52
    50
    Large intestinal stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Large intestine polyp
         subjects affected / exposed
    10 / 3576 (0.28%)
    9 / 3581 (0.25%)
    18 / 3576 (0.50%)
    24 / 3581 (0.67%)
         occurrences all number
    10
    9
    18
    24
    Leukoplakia oral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lip haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Lip ulceration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Loose tooth
         subjects affected / exposed
    11 / 3576 (0.31%)
    17 / 3581 (0.47%)
    21 / 3576 (0.59%)
    28 / 3581 (0.78%)
         occurrences all number
    12
    18
    23
    31
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Lumbar hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Megacolon
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Melaena
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Mouth cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Mouth swelling
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    3 / 3576 (0.08%)
    11 / 3581 (0.31%)
         occurrences all number
    2
    5
    3
    12
    Mucous stools
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nausea
         subjects affected / exposed
    57 / 3576 (1.59%)
    52 / 3581 (1.45%)
    68 / 3576 (1.90%)
    65 / 3581 (1.82%)
         occurrences all number
    61
    54
    74
    72
    Noninfective gingivitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    4
    3
    Odynophagia
         subjects affected / exposed
    7 / 3576 (0.20%)
    8 / 3581 (0.22%)
    7 / 3576 (0.20%)
    8 / 3581 (0.22%)
         occurrences all number
    8
    8
    8
    8
    Oesophageal achalasia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Oesophageal disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Oesophageal motility disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Oesophageal stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Oesophagitis
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    8 / 3576 (0.22%)
    14 / 3581 (0.39%)
         occurrences all number
    3
    5
    8
    14
    Oral cavity fistula
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Oral contusion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Oral discomfort
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Oral disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral lichen planus
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Oral mucosa erosion
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Oral mucosal blistering
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Oral pain
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    6
    0
    7
    0
    Pancreatic cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
         occurrences all number
    1
    2
    4
    7
    Pancreatic disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pancreatic duct dilatation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Pancreatic fistula
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pancreatic steatosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pancreatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Pancreatitis acute
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pancreatitis chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Paraesthesia oral
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Parotid gland enlargement
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Peptic ulcer
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    3
    4
    5
    Periodontal disease
         subjects affected / exposed
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
    10 / 3576 (0.28%)
    9 / 3581 (0.25%)
         occurrences all number
    6
    5
    11
    9
    Periodontal inflammation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Peritoneal lesion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Portal hypertensive gastropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Proctalgia
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    0
    5
    2
    Proctitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Rectal haemorrhage
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    2
    7
    6
    Rectal polyp
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    2
    2
    Rectal prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Rectal tenesmus
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Reflux gastritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Regurgitation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Salivary duct obstruction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Salivary gland enlargement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Sciatic hernia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Sensitivity of teeth
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    2
    3
    Stomatitis
         subjects affected / exposed
    11 / 3576 (0.31%)
    8 / 3581 (0.22%)
    15 / 3576 (0.42%)
    11 / 3581 (0.31%)
         occurrences all number
    11
    10
    17
    14
    Submaxillary gland enlargement
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Swollen tongue
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Tongue blistering
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Tongue discolouration
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Tongue disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tongue haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    0
    2
    Tongue ulceration
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Tooth deposit
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Tooth discolouration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Tooth disorder
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    9 / 3576 (0.25%)
    12 / 3581 (0.34%)
         occurrences all number
    3
    4
    9
    13
    Tooth loss
         subjects affected / exposed
    27 / 3576 (0.76%)
    26 / 3581 (0.73%)
    55 / 3576 (1.54%)
    47 / 3581 (1.31%)
         occurrences all number
    29
    27
    62
    53
    Toothache
         subjects affected / exposed
    33 / 3576 (0.92%)
    30 / 3581 (0.84%)
    48 / 3576 (1.34%)
    49 / 3581 (1.37%)
         occurrences all number
    36
    33
    52
    56
    Umbilical hernia
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
         occurrences all number
    3
    2
    6
    6
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Varices oesophageal
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Vomiting
         subjects affected / exposed
    49 / 3576 (1.37%)
    49 / 3581 (1.37%)
    61 / 3576 (1.71%)
    70 / 3581 (1.95%)
         occurrences all number
    52
    52
    68
    76
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    2
    Actinic keratosis
         subjects affected / exposed
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
    11 / 3576 (0.31%)
    10 / 3581 (0.28%)
         occurrences all number
    6
    6
    11
    10
    Alopecia
         subjects affected / exposed
    20 / 3576 (0.56%)
    24 / 3581 (0.67%)
    24 / 3576 (0.67%)
    36 / 3581 (1.01%)
         occurrences all number
    20
    24
    25
    38
    Alopecia areata
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Angiodermatitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Angioedema
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    6
    0
    6
    1
    Asteatosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Blister
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    6
    1
    7
    2
    Blister rupture
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Chronic pigmented purpura
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cutis laxa
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Dandruff
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    1
    1
    3
    Dermal cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    9 / 3581 (0.25%)
         occurrences all number
    1
    5
    7
    10
    Dermatitis
         subjects affected / exposed
    30 / 3576 (0.84%)
    14 / 3581 (0.39%)
    47 / 3576 (1.31%)
    28 / 3581 (0.78%)
         occurrences all number
    33
    15
    53
    30
    Dermatitis acneiform
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    31 / 3576 (0.87%)
    24 / 3581 (0.67%)
    51 / 3576 (1.43%)
    40 / 3581 (1.12%)
         occurrences all number
    32
    27
    56
    45
    Dermatitis atopic
         subjects affected / exposed
    5 / 3576 (0.14%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    5
    0
    6
    3
    Dermatitis bullous
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    15 / 3576 (0.42%)
    10 / 3581 (0.28%)
    22 / 3576 (0.62%)
    18 / 3581 (0.50%)
         occurrences all number
    17
    10
    26
    19
    Diabetic dermopathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Diabetic foot
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    1
    1
    3
    Drug eruption
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    4
    4
    5
    Dry skin
         subjects affected / exposed
    10 / 3576 (0.28%)
    9 / 3581 (0.25%)
    14 / 3576 (0.39%)
    13 / 3581 (0.36%)
         occurrences all number
    10
    9
    14
    13
    Dyshidrotic eczema
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Ecchymosis
         subjects affected / exposed
    28 / 3576 (0.78%)
    26 / 3581 (0.73%)
    42 / 3576 (1.17%)
    38 / 3581 (1.06%)
         occurrences all number
    32
    28
    50
    41
    Eczema
         subjects affected / exposed
    27 / 3576 (0.76%)
    23 / 3581 (0.64%)
    51 / 3576 (1.43%)
    46 / 3581 (1.28%)
         occurrences all number
    29
    24
    55
    51
    Eczema asteatotic
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    5
    1
    8
    1
    Erythema
         subjects affected / exposed
    13 / 3576 (0.36%)
    20 / 3581 (0.56%)
    19 / 3576 (0.53%)
    22 / 3581 (0.61%)
         occurrences all number
    14
    30
    21
    33
    Erythema multiforme
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Exfoliative rash
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Generalised erythema
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Granuloma annulare
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    4
    0
    5
    Haemorrhage subcutaneous
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    4
    2
    Hand dermatitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    3
    1
    Hirsutism
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    12 / 3576 (0.34%)
    4 / 3581 (0.11%)
    13 / 3576 (0.36%)
    11 / 3581 (0.31%)
         occurrences all number
    12
    4
    13
    12
    Hyperkeratosis
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    8 / 3576 (0.22%)
    11 / 3581 (0.31%)
         occurrences all number
    7
    7
    8
    11
    Hypertrophic scar
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Idiopathic urticaria
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Ingrowing nail
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    8 / 3581 (0.22%)
         occurrences all number
    4
    4
    9
    8
    Intertrigo
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    2
    3
    4
    Leukoplakia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Lichen planus
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    1
    3
    Lichen sclerosus
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Lipohypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Macule
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    3
    7
    4
    Mechanical urticaria
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    2
    Miliaria
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    3
    3
    5
    Nail bed disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Nail bed inflammation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nail discolouration
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Nail disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    0
    3
    Nail hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Nail psoriasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nail ridging
         subjects affected / exposed
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    4
    0
    4
    Neurodermatitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Night sweats
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    4
    4
    4
    Onychoclasis
         subjects affected / exposed
    15 / 3576 (0.42%)
    4 / 3581 (0.11%)
    15 / 3576 (0.42%)
    4 / 3581 (0.11%)
         occurrences all number
    15
    4
    15
    5
    Onycholysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    0
    3
    Onychomadesis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Onychomalacia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pain of skin
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Palmoplantar keratoderma
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Panniculitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Papule
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    5
    3
    5
    4
    Peau d'orange
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    4
    0
    Petechiae
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Pigmentation disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Pityriasis rosea
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Pruritus
         subjects affected / exposed
    47 / 3576 (1.31%)
    45 / 3581 (1.26%)
    66 / 3576 (1.85%)
    54 / 3581 (1.51%)
         occurrences all number
    49
    53
    71
    63
    Pruritus allergic
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    1 / 3581 (0.03%)
         occurrences all number
    7
    1
    8
    1
    Pruritus generalised
         subjects affected / exposed
    20 / 3576 (0.56%)
    17 / 3581 (0.47%)
    27 / 3576 (0.76%)
    22 / 3581 (0.61%)
         occurrences all number
    22
    20
    31
    25
    Psoriasis
         subjects affected / exposed
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
    12 / 3576 (0.34%)
    8 / 3581 (0.22%)
         occurrences all number
    8
    7
    15
    11
    Purpura
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Rash
         subjects affected / exposed
    31 / 3576 (0.87%)
    38 / 3581 (1.06%)
    53 / 3576 (1.48%)
    57 / 3581 (1.59%)
         occurrences all number
    37
    44
    61
    68
    Rash erythematous
         subjects affected / exposed
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    5
    0
    5
    Rash generalised
         subjects affected / exposed
    0 / 3576 (0.00%)
    5 / 3581 (0.14%)
    0 / 3576 (0.00%)
    7 / 3581 (0.20%)
         occurrences all number
    0
    5
    0
    7
    Rash macular
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    1
    3
    Rash maculo-papular
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Rash papular
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    3
    1
    4
    Rash pruritic
         subjects affected / exposed
    15 / 3576 (0.42%)
    11 / 3581 (0.31%)
    18 / 3576 (0.50%)
    17 / 3581 (0.47%)
         occurrences all number
    16
    12
    22
    19
    Rosacea
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    1
    3
    3
    Scab
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Scar pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
         occurrences all number
    3
    8
    5
    10
    Skin atrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin burning sensation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    0
    2
    Skin discolouration
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    4
    0
    Skin disorder
         subjects affected / exposed
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
    6 / 3576 (0.17%)
    7 / 3581 (0.20%)
         occurrences all number
    5
    7
    7
    7
    Skin erosion
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin exfoliation
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    4
    1
    5
    1
    Skin fissures
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    3
    2
    Skin haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    0
    4
    1
    Skin hypertrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    2
    0
    2
    Skin induration
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin irritation
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    1
    3
    3
    Skin lesion
         subjects affected / exposed
    20 / 3576 (0.56%)
    12 / 3581 (0.34%)
    27 / 3576 (0.76%)
    22 / 3581 (0.61%)
         occurrences all number
    20
    13
    28
    23
    Skin mass
         subjects affected / exposed
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    4
    0
    5
    1
    Skin plaque
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin swelling
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin ulcer
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    11 / 3581 (0.31%)
         occurrences all number
    7
    4
    10
    12
    Skin ulcer haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin warm
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Solar dermatitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Solar lentigo
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Stasis dermatitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sweat gland disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Swelling face
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    2
    1
    2
    Telangiectasia
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Transient acantholytic dermatosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Trichorrhexis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Urticaria
         subjects affected / exposed
    22 / 3576 (0.62%)
    18 / 3581 (0.50%)
    29 / 3576 (0.81%)
    27 / 3581 (0.75%)
         occurrences all number
    23
    22
    31
    33
    Urticaria chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Vascular purpura
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vascular skin disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vitiligo
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    2
    2
    Xeroderma
         subjects affected / exposed
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
    12 / 3576 (0.34%)
    12 / 3581 (0.34%)
         occurrences all number
    5
    8
    12
    13
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    4
    4
    Azotaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Bladder disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bladder diverticulum
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Bladder dysfunction
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Bladder pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bladder prolapse
         subjects affected / exposed
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    4
    0
    4
    Bladder spasm
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    3
    2
    Calculus bladder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Calculus urinary
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    5
    0
    Choluria
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Chromaturia
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    0
    4
    Chronic kidney disease
         subjects affected / exposed
    13 / 3576 (0.36%)
    19 / 3581 (0.53%)
    30 / 3576 (0.84%)
    34 / 3581 (0.95%)
         occurrences all number
    13
    20
    31
    36
    Cystitis haemorrhagic
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    2
    3
    Cystitis interstitial
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cystitis noninfective
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    4
    2
    Diabetic nephropathy
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    3
    4
    4
    Dysuria
         subjects affected / exposed
    10 / 3576 (0.28%)
    16 / 3581 (0.45%)
    23 / 3576 (0.64%)
    24 / 3581 (0.67%)
         occurrences all number
    10
    17
    24
    27
    Haematuria
         subjects affected / exposed
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
    11 / 3576 (0.31%)
    12 / 3581 (0.34%)
         occurrences all number
    5
    8
    13
    14
    Hydrocalyx
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hydronephrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    1
    0
    4
    Hypercalciuria
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hypertensive nephropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Hypertonic bladder
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    9 / 3581 (0.25%)
         occurrences all number
    3
    5
    7
    9
    Incontinence
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    3
    2
    4
    Kidney enlargement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Kidney fibrosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Leukocyturia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    3
    Microalbuminuria
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Micturition disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    3
    3
    Nephrocalcinosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    15 / 3576 (0.42%)
    17 / 3581 (0.47%)
    30 / 3576 (0.84%)
    33 / 3581 (0.92%)
         occurrences all number
    15
    17
    31
    33
    Nephropathy
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences all number
    3
    0
    3
    5
    Nephrosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neurogenic bladder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nocturia
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    3
    3
    4
    Pollakiuria
         subjects affected / exposed
    9 / 3576 (0.25%)
    6 / 3581 (0.17%)
    17 / 3576 (0.48%)
    9 / 3581 (0.25%)
         occurrences all number
    9
    8
    17
    11
    Polyuria
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    2
    5
    2
    Proteinuria
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    1
    6
    2
    Pyelocaliectasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    2
    2
    4
    Renal artery stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Renal atrophy
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    3
    4
    Renal colic
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    2
    4
    4
    Renal cyst
         subjects affected / exposed
    12 / 3576 (0.34%)
    23 / 3581 (0.64%)
    39 / 3576 (1.09%)
    44 / 3581 (1.23%)
         occurrences all number
    12
    24
    41
    46
    Renal disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    2
    2
    Renal failure
         subjects affected / exposed
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
    16 / 3576 (0.45%)
    12 / 3581 (0.34%)
         occurrences all number
    6
    8
    18
    13
    Renal impairment
         subjects affected / exposed
    14 / 3576 (0.39%)
    9 / 3581 (0.25%)
    23 / 3576 (0.64%)
    23 / 3581 (0.64%)
         occurrences all number
    14
    9
    23
    24
    Renal lipomatosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal mass
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Renal pain
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    2
    3
    Stress urinary incontinence
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    4
    1
    Ureteric dilatation
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Ureteric stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Ureterolithiasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Urethral caruncle
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Urethral pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Urethral stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Urethral syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urge incontinence
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Urinary hesitation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urinary incontinence
         subjects affected / exposed
    14 / 3576 (0.39%)
    15 / 3581 (0.42%)
    28 / 3576 (0.78%)
    29 / 3581 (0.81%)
         occurrences all number
    14
    16
    28
    30
    Urinary retention
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    1
    3
    5
    Urinary tract disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Urinary tract inflammation
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Urine flow decreased
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urine odour abnormal
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Urogenital haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endocrine disorders
    Adrenal disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Adrenal insufficiency
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Adrenal mass
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Autoimmune thyroiditis
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
         occurrences all number
    4
    1
    6
    6
    Endocrine disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Goitre
         subjects affected / exposed
    17 / 3576 (0.48%)
    16 / 3581 (0.45%)
    41 / 3576 (1.15%)
    33 / 3581 (0.92%)
         occurrences all number
    17
    17
    42
    34
    Haemorrhagic thyroid cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    1
    3
    4
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Hyperthyroidism
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    10 / 3581 (0.28%)
         occurrences all number
    2
    5
    6
    10
    Hypoparathyroidism
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypothyroidic goitre
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    40 / 3576 (1.12%)
    41 / 3581 (1.14%)
    74 / 3576 (2.07%)
    79 / 3581 (2.21%)
         occurrences all number
    41
    41
    79
    81
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Myxoedema
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Primary hypothyroidism
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    2
    1
    Secondary hypothyroidism
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Thyroid atrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Thyroid cyst
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    5
    1
    Thyroid disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Thyroid mass
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    9 / 3576 (0.25%)
    8 / 3581 (0.22%)
         occurrences all number
    5
    2
    10
    10
    Thyroiditis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Thyroiditis chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Thyroiditis subacute
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Ankle deformity
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    434 / 3576 (12.14%)
    468 / 3581 (13.07%)
    663 / 3576 (18.54%)
    668 / 3581 (18.65%)
         occurrences all number
    532
    594
    882
    928
    Arthritis
         subjects affected / exposed
    12 / 3576 (0.34%)
    19 / 3581 (0.53%)
    18 / 3576 (0.50%)
    30 / 3581 (0.84%)
         occurrences all number
    12
    20
    21
    31
    Arthritis reactive
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Arthropathy
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    1
    5
    4
    Back pain
         subjects affected / exposed
    380 / 3576 (10.63%)
    373 / 3581 (10.42%)
    573 / 3576 (16.02%)
    518 / 3581 (14.47%)
         occurrences all number
    431
    434
    707
    649
    Bone atrophy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bone cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    3
    1
    Bone deformity
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Bone disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    1
    2
    Bone infarction
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Bone loss
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    2
    2
    Bone pain
         subjects affected / exposed
    47 / 3576 (1.31%)
    55 / 3581 (1.54%)
    62 / 3576 (1.73%)
    72 / 3581 (2.01%)
         occurrences all number
    60
    67
    78
    87
    Bursitis
         subjects affected / exposed
    13 / 3576 (0.36%)
    19 / 3581 (0.53%)
    21 / 3576 (0.59%)
    33 / 3581 (0.92%)
         occurrences all number
    13
    20
    22
    36
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    2
    2
    Chondritis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Chondrocalcinosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Chondrolysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Chondromalacia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Chondropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    1
    2
    5
    Coccydynia
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    2
    6
    7
    Costochondritis
         subjects affected / exposed
    14 / 3576 (0.39%)
    8 / 3581 (0.22%)
    25 / 3576 (0.70%)
    16 / 3581 (0.45%)
         occurrences all number
    14
    9
    26
    17
    Crystal arthropathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Deformity thorax
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Dupuytren's contracture
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    2
    2
    Enthesopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    2
    2
    5
    Exostosis
         subjects affected / exposed
    12 / 3576 (0.34%)
    6 / 3581 (0.17%)
    26 / 3576 (0.73%)
    18 / 3581 (0.50%)
         occurrences all number
    14
    7
    28
    20
    Extremity contracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Facial asymmetry
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fasciitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Fibromyalgia
         subjects affected / exposed
    10 / 3576 (0.28%)
    5 / 3581 (0.14%)
    11 / 3576 (0.31%)
    7 / 3581 (0.20%)
         occurrences all number
    10
    5
    11
    7
    Finger deformity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Fistula
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Flank pain
         subjects affected / exposed
    4 / 3576 (0.11%)
    12 / 3581 (0.34%)
    9 / 3576 (0.25%)
    13 / 3581 (0.36%)
         occurrences all number
    4
    12
    9
    14
    Foot deformity
         subjects affected / exposed
    8 / 3576 (0.22%)
    9 / 3581 (0.25%)
    15 / 3576 (0.42%)
    14 / 3581 (0.39%)
         occurrences all number
    9
    10
    17
    15
    Fracture delayed union
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Fracture pain
         subjects affected / exposed
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
         occurrences all number
    5
    5
    5
    5
    Gouty arthritis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Groin pain
         subjects affected / exposed
    9 / 3576 (0.25%)
    14 / 3581 (0.39%)
    17 / 3576 (0.48%)
    19 / 3581 (0.53%)
         occurrences all number
    11
    14
    20
    19
    Interspinous osteoarthritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Intervertebral disc compression
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    2
    7
    6
    Intervertebral disc disorder
         subjects affected / exposed
    12 / 3576 (0.34%)
    16 / 3581 (0.45%)
    22 / 3576 (0.62%)
    28 / 3581 (0.78%)
         occurrences all number
    13
    16
    26
    28
    Intervertebral disc displacement
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    12 / 3576 (0.34%)
    8 / 3581 (0.22%)
    24 / 3576 (0.67%)
    16 / 3581 (0.45%)
         occurrences all number
    14
    8
    29
    17
    Intervertebral disc space narrowing
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    1
    3
    Jaw cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Joint contracture
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    2
    4
    2
    Joint crepitation
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
         occurrences all number
    3
    1
    4
    1
    Joint effusion
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    4
    3
    Joint hyperextension
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Joint lock
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Joint range of motion decreased
         subjects affected / exposed
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
    10 / 3576 (0.28%)
    3 / 3581 (0.08%)
         occurrences all number
    6
    3
    10
    3
    Joint stiffness
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    4 / 3576 (0.11%)
    7 / 3581 (0.20%)
         occurrences all number
    3
    5
    5
    7
    Joint swelling
         subjects affected / exposed
    21 / 3576 (0.59%)
    16 / 3581 (0.45%)
    29 / 3576 (0.81%)
    26 / 3581 (0.73%)
         occurrences all number
    23
    18
    31
    28
    Joint warmth
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Kyphosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    8 / 3576 (0.22%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    8
    2
    Ligamentitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Limb asymmetry
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Limb discomfort
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    3
    2
    4
    Limb mass
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Lordosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    2
    2
    4
    Low turnover osteopathy
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Lumbar spinal stenosis
         subjects affected / exposed
    6 / 3576 (0.17%)
    8 / 3581 (0.22%)
    11 / 3576 (0.31%)
    15 / 3581 (0.42%)
         occurrences all number
    6
    8
    12
    15
    Mastication disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Meniscal degeneration
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Metatarsalgia
         subjects affected / exposed
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
    11 / 3576 (0.31%)
    3 / 3581 (0.08%)
         occurrences all number
    8
    3
    12
    3
    Mobility decreased
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Monarthritis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Muscle atrophy
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Muscle contracture
         subjects affected / exposed
    20 / 3576 (0.56%)
    21 / 3581 (0.59%)
    24 / 3576 (0.67%)
    25 / 3581 (0.70%)
         occurrences all number
    23
    23
    27
    27
    Muscle fatigue
         subjects affected / exposed
    8 / 3576 (0.22%)
    2 / 3581 (0.06%)
    8 / 3576 (0.22%)
    3 / 3581 (0.08%)
         occurrences all number
    8
    2
    8
    3
    Muscle haemorrhage
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Muscle spasms
         subjects affected / exposed
    140 / 3576 (3.91%)
    163 / 3581 (4.55%)
    201 / 3576 (5.62%)
    211 / 3581 (5.89%)
         occurrences all number
    155
    179
    236
    246
    Muscle tightness
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    5
    1
    Muscle twitching
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    20 / 3576 (0.56%)
    19 / 3581 (0.53%)
    32 / 3576 (0.89%)
    29 / 3581 (0.81%)
         occurrences all number
    22
    21
    34
    31
    Musculoskeletal chest pain
         subjects affected / exposed
    21 / 3576 (0.59%)
    14 / 3581 (0.39%)
    37 / 3576 (1.03%)
    28 / 3581 (0.78%)
         occurrences all number
    21
    14
    38
    29
    Musculoskeletal discomfort
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
         occurrences all number
    2
    5
    3
    7
    Musculoskeletal disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    172 / 3576 (4.81%)
    168 / 3581 (4.69%)
    260 / 3576 (7.27%)
    263 / 3581 (7.34%)
         occurrences all number
    188
    182
    301
    304
    Musculoskeletal stiffness
         subjects affected / exposed
    16 / 3576 (0.45%)
    18 / 3581 (0.50%)
    20 / 3576 (0.56%)
    20 / 3581 (0.56%)
         occurrences all number
    17
    19
    22
    22
    Myalgia
         subjects affected / exposed
    127 / 3576 (3.55%)
    114 / 3581 (3.18%)
    175 / 3576 (4.89%)
    159 / 3581 (4.44%)
         occurrences all number
    150
    129
    206
    181
    Myofascial pain syndrome
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    1
    4
    5
    Myofascitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Myositis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Myositis ossificans
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neck deformity
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neck pain
         subjects affected / exposed
    54 / 3576 (1.51%)
    80 / 3581 (2.23%)
    83 / 3576 (2.32%)
    116 / 3581 (3.24%)
         occurrences all number
    61
    85
    93
    127
    Nodal osteoarthritis
         subjects affected / exposed
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
    9 / 3576 (0.25%)
    6 / 3581 (0.17%)
         occurrences all number
    7
    3
    9
    6
    Osteitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    0
    5
    3
    Osteoarthritis
         subjects affected / exposed
    210 / 3576 (5.87%)
    184 / 3581 (5.14%)
    329 / 3576 (9.20%)
    321 / 3581 (8.96%)
         occurrences all number
    235
    221
    381
    398
    Osteochondritis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Osteochondrosis
         subjects affected / exposed
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
    10 / 3576 (0.28%)
    10 / 3581 (0.28%)
         occurrences all number
    6
    5
    12
    10
    Osteolysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Osteonecrosis
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    4
    4
    Osteopenia
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Osteoporosis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    9 / 3576 (0.25%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    9
    2
    Osteosclerosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    2
    1
    8
    Pain in extremity
         subjects affected / exposed
    299 / 3576 (8.36%)
    278 / 3581 (7.76%)
    407 / 3576 (11.38%)
    417 / 3581 (11.64%)
         occurrences all number
    356
    353
    510
    536
    Pain in jaw
         subjects affected / exposed
    1 / 3576 (0.03%)
    8 / 3581 (0.22%)
    5 / 3576 (0.14%)
    8 / 3581 (0.22%)
         occurrences all number
    1
    8
    5
    9
    Palindromic rheumatism
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    2
    Patellofemoral pain syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Periarthritis
         subjects affected / exposed
    19 / 3576 (0.53%)
    10 / 3581 (0.28%)
    31 / 3576 (0.87%)
    25 / 3581 (0.70%)
         occurrences all number
    20
    10
    35
    27
    Periostitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    3
    2
    3
    Peripheral arthritis
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    0
    4
    2
    Plantar fasciitis
         subjects affected / exposed
    5 / 3576 (0.14%)
    10 / 3581 (0.28%)
    10 / 3576 (0.28%)
    18 / 3581 (0.50%)
         occurrences all number
    5
    10
    10
    18
    Polyarthritis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    5
    2
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    7
    3
    Rheumatic disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    4 / 3576 (0.11%)
    0 / 3581 (0.00%)
    8 / 3576 (0.22%)
    7 / 3581 (0.20%)
         occurrences all number
    4
    0
    8
    7
    Rib deformity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    12 / 3576 (0.34%)
    9 / 3581 (0.25%)
    22 / 3576 (0.62%)
    18 / 3581 (0.50%)
         occurrences all number
    12
    9
    22
    18
    Sacroiliitis
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    2
    6
    4
    Sarcopenia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Scoliosis
         subjects affected / exposed
    8 / 3576 (0.22%)
    8 / 3581 (0.22%)
    18 / 3576 (0.50%)
    17 / 3581 (0.47%)
         occurrences all number
    8
    9
    18
    18
    Senile ankylosing vertebral hyperostosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seronegative arthritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Sinus tarsi syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Sjogren's syndrome
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    3
    3
    5
    Spinal column stenosis
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    8 / 3576 (0.22%)
    6 / 3581 (0.17%)
         occurrences all number
    6
    2
    9
    6
    Spinal deformity
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    3
    2
    Spinal disorder
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Spinal flattening
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    86 / 3576 (2.40%)
    86 / 3581 (2.40%)
    138 / 3576 (3.86%)
    137 / 3581 (3.83%)
         occurrences all number
    105
    105
    183
    188
    Spinal pain
         subjects affected / exposed
    42 / 3576 (1.17%)
    33 / 3581 (0.92%)
    57 / 3576 (1.59%)
    62 / 3581 (1.73%)
         occurrences all number
    43
    37
    62
    68
    Spondylitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    1
    2
    Spondylolisthesis
         subjects affected / exposed
    6 / 3576 (0.17%)
    7 / 3581 (0.20%)
    10 / 3576 (0.28%)
    16 / 3581 (0.45%)
         occurrences all number
    6
    7
    11
    16
    Spondylolysis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Sympathetic posterior cervical syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Synovial cyst
         subjects affected / exposed
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
    22 / 3576 (0.62%)
    28 / 3581 (0.78%)
         occurrences all number
    12
    13
    23
    29
    Synovitis
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
         occurrences all number
    3
    0
    7
    3
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
    10 / 3576 (0.28%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    5
    12
    7
    Tendinous contracture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Tendon disorder
         subjects affected / exposed
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
    7 / 3576 (0.20%)
    8 / 3581 (0.22%)
         occurrences all number
    6
    2
    7
    8
    Tendon pain
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    2
    1
    Tendonitis
         subjects affected / exposed
    20 / 3576 (0.56%)
    28 / 3581 (0.78%)
    37 / 3576 (1.03%)
    44 / 3581 (1.23%)
         occurrences all number
    20
    28
    39
    45
    Tenosynovitis
         subjects affected / exposed
    8 / 3576 (0.22%)
    8 / 3581 (0.22%)
    16 / 3576 (0.45%)
    16 / 3581 (0.45%)
         occurrences all number
    8
    9
    17
    18
    Tenosynovitis stenosans
         subjects affected / exposed
    8 / 3576 (0.22%)
    7 / 3581 (0.20%)
    9 / 3576 (0.25%)
    10 / 3581 (0.28%)
         occurrences all number
    8
    7
    9
    10
    Torticollis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Trigger finger
         subjects affected / exposed
    13 / 3576 (0.36%)
    14 / 3581 (0.39%)
    26 / 3576 (0.73%)
    25 / 3581 (0.70%)
         occurrences all number
    14
    15
    27
    27
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    4
    1
    Vertebral osteophyte
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vertebral wedging
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Wrist deformity
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Abscess bacterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Abscess jaw
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Abscess limb
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    3
    5
    3
    Abscess neck
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abscess of eyelid
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abscess oral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abscess rupture
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Acarodermatitis
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    3
    7
    5
    Actinomycotic pulmonary infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Acute sinusitis
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    4 / 3576 (0.11%)
    9 / 3581 (0.25%)
         occurrences all number
    3
    6
    4
    12
    Alphaviral infection
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Amoebiasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    2
    3
    5
    Amoebic dysentery
         subjects affected / exposed
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
    2 / 3576 (0.06%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    5
    2
    6
    Anal abscess
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    3
    1
    3
    Appendicitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthritis bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ascariasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Asymptomatic bacteriuria
         subjects affected / exposed
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
    7 / 3576 (0.20%)
    9 / 3581 (0.25%)
         occurrences all number
    2
    4
    7
    9
    Atypical pneumonia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Bacteraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Bacterial diarrhoea
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    4
    2
    Bacterial infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Bacterial rhinitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacterial vaginosis
         subjects affected / exposed
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
    4 / 3576 (0.11%)
    9 / 3581 (0.25%)
         occurrences all number
    3
    7
    4
    9
    Bacteriuria
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Blastocystis infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Borrelia infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    1
    2
    Bronchiolitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    3
    3
    Bronchitis
         subjects affected / exposed
    90 / 3576 (2.52%)
    80 / 3581 (2.23%)
    162 / 3576 (4.53%)
    173 / 3581 (4.83%)
         occurrences all number
    97
    83
    196
    205
    Bronchitis bacterial
         subjects affected / exposed
    21 / 3576 (0.59%)
    12 / 3581 (0.34%)
    24 / 3576 (0.67%)
    15 / 3581 (0.42%)
         occurrences all number
    22
    14
    28
    17
    Bronchitis viral
         subjects affected / exposed
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
    9 / 3576 (0.25%)
    4 / 3581 (0.11%)
         occurrences all number
    6
    3
    9
    4
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Candida infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    1
    2
    Cellulitis
         subjects affected / exposed
    16 / 3576 (0.45%)
    13 / 3581 (0.36%)
    24 / 3576 (0.67%)
    27 / 3581 (0.75%)
         occurrences all number
    16
    13
    24
    30
    Chikungunya virus infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    2
    2
    Cholecystitis infective
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Chronic hepatitis C
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Chronic sinusitis
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    11 / 3576 (0.31%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    2
    11
    7
    Chronic tonsillitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    2
    Clostridial infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    24 / 3576 (0.67%)
    34 / 3581 (0.95%)
    42 / 3576 (1.17%)
    54 / 3581 (1.51%)
         occurrences all number
    25
    36
    43
    57
    Conjunctivitis bacterial
         subjects affected / exposed
    8 / 3576 (0.22%)
    11 / 3581 (0.31%)
    9 / 3576 (0.25%)
    14 / 3581 (0.39%)
         occurrences all number
    8
    11
    9
    14
    Conjunctivitis viral
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    1
    3
    Cystitis
         subjects affected / exposed
    49 / 3576 (1.37%)
    56 / 3581 (1.56%)
    84 / 3576 (2.35%)
    84 / 3581 (2.35%)
         occurrences all number
    61
    62
    114
    100
    Cystitis bacterial
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    9 / 3576 (0.25%)
    8 / 3581 (0.22%)
         occurrences all number
    8
    12
    10
    19
    Cystitis escherichia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Cystitis klebsiella
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cystitis viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Dacryocystitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Dengue fever
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    7 / 3576 (0.20%)
    6 / 3581 (0.17%)
         occurrences all number
    0
    0
    8
    6
    Dental fistula
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Dental gangrene
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Dermatitis infected
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Dermatophytosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatophytosis of nail
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    1
    1
    4
    Diarrhoea infectious
         subjects affected / exposed
    3 / 3576 (0.08%)
    7 / 3581 (0.20%)
    3 / 3576 (0.08%)
    8 / 3581 (0.22%)
         occurrences all number
    3
    7
    3
    8
    Diverticulitis
         subjects affected / exposed
    4 / 3576 (0.11%)
    6 / 3581 (0.17%)
    9 / 3576 (0.25%)
    8 / 3581 (0.22%)
         occurrences all number
    4
    6
    9
    9
    Dysentery
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    13 / 3576 (0.36%)
    8 / 3581 (0.22%)
    16 / 3576 (0.45%)
    17 / 3581 (0.47%)
         occurrences all number
    13
    8
    16
    18
    Ear infection bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    2
    2
    Ear infection viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Eczema impetiginous
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Eczema infected
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Enteritis infectious
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Enterobiasis
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Erysipelas
         subjects affected / exposed
    6 / 3576 (0.17%)
    5 / 3581 (0.14%)
    14 / 3576 (0.39%)
    9 / 3581 (0.25%)
         occurrences all number
    7
    5
    15
    10
    Erythema migrans
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    3
    1
    4
    Escherichia urinary tract infection
         subjects affected / exposed
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
    12 / 3576 (0.34%)
    5 / 3581 (0.14%)
         occurrences all number
    8
    5
    13
    5
    Eye infection
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    4
    2
    Eye infection bacterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eyelid infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Flavivirus infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Folliculitis
         subjects affected / exposed
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
         occurrences all number
    5
    4
    5
    8
    Fungal infection
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    3
    2
    Fungal skin infection
         subjects affected / exposed
    10 / 3576 (0.28%)
    9 / 3581 (0.25%)
    18 / 3576 (0.50%)
    13 / 3581 (0.36%)
         occurrences all number
    10
    9
    18
    13
    Furuncle
         subjects affected / exposed
    7 / 3576 (0.20%)
    4 / 3581 (0.11%)
    12 / 3576 (0.34%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    4
    13
    7
    Gastric infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastric ulcer helicobacter
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastritis viral
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Gastroenteritis
         subjects affected / exposed
    57 / 3576 (1.59%)
    49 / 3581 (1.37%)
    83 / 3576 (2.32%)
    99 / 3581 (2.76%)
         occurrences all number
    62
    53
    93
    107
    Gastroenteritis bacterial
         subjects affected / exposed
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    6
    6
    6
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Gastroenteritis viral
         subjects affected / exposed
    47 / 3576 (1.31%)
    43 / 3581 (1.20%)
    63 / 3576 (1.76%)
    63 / 3581 (1.76%)
         occurrences all number
    49
    43
    66
    65
    Gastrointestinal bacterial infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
         occurrences all number
    4
    3
    5
    6
    Gastrointestinal viral infection
         subjects affected / exposed
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    3
    6
    4
    Genital herpes
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
         occurrences all number
    3
    5
    10
    6
    Genital infection fungal
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Giardiasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    3
    2
    3
    Gingival abscess
         subjects affected / exposed
    5 / 3576 (0.14%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    0 / 3581 (0.00%)
         occurrences all number
    5
    0
    6
    0
    Gingivitis
         subjects affected / exposed
    22 / 3576 (0.62%)
    32 / 3581 (0.89%)
    26 / 3576 (0.73%)
    38 / 3581 (1.06%)
         occurrences all number
    22
    32
    28
    38
    Groin abscess
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Haemophilus infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Helicobacter gastritis
         subjects affected / exposed
    5 / 3576 (0.14%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    9 / 3581 (0.25%)
         occurrences all number
    6
    4
    10
    9
    Helicobacter infection
         subjects affected / exposed
    10 / 3576 (0.28%)
    11 / 3581 (0.31%)
    26 / 3576 (0.73%)
    22 / 3581 (0.61%)
         occurrences all number
    10
    11
    26
    22
    Helminthic infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    0
    3
    Hepatitis B
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hepatitis C
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Hepatitis viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    1
    1
    Herpes dermatitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    1
    1
    Herpes ophthalmic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Herpes simplex
         subjects affected / exposed
    3 / 3576 (0.08%)
    6 / 3581 (0.17%)
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    6
    10
    6
    Herpes virus infection
         subjects affected / exposed
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    3
    6
    5
    Herpes zoster
         subjects affected / exposed
    22 / 3576 (0.62%)
    33 / 3581 (0.92%)
    61 / 3576 (1.71%)
    72 / 3581 (2.01%)
         occurrences all number
    24
    33
    63
    73
    Herpes zoster infection neurological
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Herpes zoster oticus
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hookworm infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Hordeolum
         subjects affected / exposed
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
    11 / 3576 (0.31%)
    4 / 3581 (0.11%)
         occurrences all number
    6
    2
    11
    4
    Impetigo
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Incision site infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infected bite
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    3
    2
    Infected cyst
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Infected dermal cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Infected skin ulcer
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    1
    2
    Infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    2
    3
    Infection parasitic
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    2
    1
    4
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    2
    1
    Influenza
         subjects affected / exposed
    180 / 3576 (5.03%)
    169 / 3581 (4.72%)
    240 / 3576 (6.71%)
    237 / 3581 (6.62%)
         occurrences all number
    221
    207
    306
    292
    Injection site infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Kaposi's varicelliform eruption
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Keratitis viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Labyrinthitis
         subjects affected / exposed
    12 / 3576 (0.34%)
    7 / 3581 (0.20%)
    21 / 3576 (0.59%)
    16 / 3581 (0.45%)
         occurrences all number
    13
    7
    25
    19
    Laryngitis
         subjects affected / exposed
    13 / 3576 (0.36%)
    16 / 3581 (0.45%)
    18 / 3576 (0.50%)
    29 / 3581 (0.81%)
         occurrences all number
    14
    17
    23
    32
    Laryngitis bacterial
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Laryngitis viral
         subjects affected / exposed
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    6
    2
    6
    2
    Latent syphilis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Localised infection
         subjects affected / exposed
    8 / 3576 (0.22%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    7 / 3581 (0.20%)
         occurrences all number
    8
    4
    9
    7
    Lower respiratory tract infection
         subjects affected / exposed
    18 / 3576 (0.50%)
    18 / 3581 (0.50%)
    36 / 3576 (1.01%)
    31 / 3581 (0.87%)
         occurrences all number
    22
    18
    55
    40
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    4
    5
    5
    5
    Lower respiratory tract infection viral
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Lung infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    4
    3
    6
    Lyme disease
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
         occurrences all number
    4
    1
    6
    2
    Malaria
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Mastitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Mastitis bacterial
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Mastoiditis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    1
    1
    Mumps
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Mycobacterial infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Myringitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Nail bed infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nail bed infection bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nail infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    439 / 3576 (12.28%)
    460 / 3581 (12.85%)
    622 / 3576 (17.39%)
    651 / 3581 (18.18%)
         occurrences all number
    545
    570
    936
    921
    Nematodiasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Onychomycosis
         subjects affected / exposed
    10 / 3576 (0.28%)
    16 / 3581 (0.45%)
    21 / 3576 (0.59%)
    26 / 3581 (0.73%)
         occurrences all number
    10
    16
    22
    28
    Oral bacterial infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    0
    1
    1
    Oral candidiasis
         subjects affected / exposed
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
    9 / 3576 (0.25%)
    12 / 3581 (0.34%)
         occurrences all number
    5
    6
    11
    13
    Oral fungal infection
         subjects affected / exposed
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
    6 / 3576 (0.17%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    1
    6
    2
    Oral herpes
         subjects affected / exposed
    17 / 3576 (0.48%)
    22 / 3581 (0.61%)
    22 / 3576 (0.62%)
    31 / 3581 (0.87%)
         occurrences all number
    18
    22
    23
    32
    Oral infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Oral viral infection
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    2
    1
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Osteomyelitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Otitis externa
         subjects affected / exposed
    1 / 3576 (0.03%)
    9 / 3581 (0.25%)
    6 / 3576 (0.17%)
    11 / 3581 (0.31%)
         occurrences all number
    1
    10
    6
    12
    Otitis externa bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    2
    0
    2
    Otitis media
         subjects affected / exposed
    3 / 3576 (0.08%)
    5 / 3581 (0.14%)
    8 / 3576 (0.22%)
    8 / 3581 (0.22%)
         occurrences all number
    3
    5
    8
    9
    Otitis media acute
         subjects affected / exposed
    4 / 3576 (0.11%)
    5 / 3581 (0.14%)
    7 / 3576 (0.20%)
    8 / 3581 (0.22%)
         occurrences all number
    4
    5
    8
    8
    Otitis media bacterial
         subjects affected / exposed
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    3
    2
    4
    2
    Otitis media chronic
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Otosalpingitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Parasitic gastroenteritis
         subjects affected / exposed
    7 / 3576 (0.20%)
    2 / 3581 (0.06%)
    10 / 3576 (0.28%)
    3 / 3581 (0.08%)
         occurrences all number
    7
    2
    10
    3
    Paronychia
         subjects affected / exposed
    6 / 3576 (0.17%)
    4 / 3581 (0.11%)
    8 / 3576 (0.22%)
    9 / 3581 (0.25%)
         occurrences all number
    8
    4
    10
    9
    Parotitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    1
    1
    4
    1
    Pelvic inflammatory disease
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Peptic ulcer helicobacter
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Perichondritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Pericoronitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Periodontitis
         subjects affected / exposed
    31 / 3576 (0.87%)
    20 / 3581 (0.56%)
    47 / 3576 (1.31%)
    37 / 3581 (1.03%)
         occurrences all number
    33
    23
    50
    40
    Periorbital cellulitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Peritonsillar abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    1
    2
    Pharyngitis
         subjects affected / exposed
    31 / 3576 (0.87%)
    36 / 3581 (1.01%)
    61 / 3576 (1.71%)
    69 / 3581 (1.93%)
         occurrences all number
    36
    39
    72
    77
    Pharyngitis bacterial
         subjects affected / exposed
    9 / 3576 (0.25%)
    7 / 3581 (0.20%)
    10 / 3576 (0.28%)
    13 / 3581 (0.36%)
         occurrences all number
    9
    8
    10
    14
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    2
    3
    3
    Pilonidal cyst
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Pneumonia
         subjects affected / exposed
    36 / 3576 (1.01%)
    35 / 3581 (0.98%)
    64 / 3576 (1.79%)
    64 / 3581 (1.79%)
         occurrences all number
    38
    35
    81
    72
    Pneumonia adenoviral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pneumonia bacterial
         subjects affected / exposed
    10 / 3576 (0.28%)
    6 / 3581 (0.17%)
    13 / 3576 (0.36%)
    8 / 3581 (0.22%)
         occurrences all number
    11
    6
    15
    8
    Pneumonia cryptococcal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Pneumonia viral
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Post procedural infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    3
    1
    Post viral fatigue syndrome
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    4 / 3576 (0.11%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    5
    2
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pulpitis dental
         subjects affected / exposed
    11 / 3576 (0.31%)
    7 / 3581 (0.20%)
    14 / 3576 (0.39%)
    11 / 3581 (0.31%)
         occurrences all number
    14
    7
    17
    12
    Pyelonephritis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    1
    3
    Pyelonephritis acute
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Pyuria
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    2
    1
    3
    Respiratory tract infection
         subjects affected / exposed
    13 / 3576 (0.36%)
    19 / 3581 (0.53%)
    34 / 3576 (0.95%)
    39 / 3581 (1.09%)
         occurrences all number
    15
    19
    39
    41
    Respiratory tract infection bacterial
         subjects affected / exposed
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
    6 / 3576 (0.17%)
    6 / 3581 (0.17%)
         occurrences all number
    5
    5
    6
    6
    Respiratory tract infection viral
         subjects affected / exposed
    23 / 3576 (0.64%)
    10 / 3581 (0.28%)
    29 / 3576 (0.81%)
    10 / 3581 (0.28%)
         occurrences all number
    28
    12
    38
    12
    Rhinitis
         subjects affected / exposed
    35 / 3576 (0.98%)
    38 / 3581 (1.06%)
    56 / 3576 (1.57%)
    59 / 3581 (1.65%)
         occurrences all number
    37
    39
    59
    66
    Root canal infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Rotavirus infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sialoadenitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sinobronchitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    27 / 3576 (0.76%)
    51 / 3581 (1.42%)
    55 / 3576 (1.54%)
    80 / 3581 (2.23%)
         occurrences all number
    28
    54
    62
    88
    Sinusitis bacterial
         subjects affected / exposed
    5 / 3576 (0.14%)
    3 / 3581 (0.08%)
    7 / 3576 (0.20%)
    5 / 3581 (0.14%)
         occurrences all number
    6
    3
    8
    5
    Skin bacterial infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Skin candida
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Skin infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
         occurrences all number
    1
    4
    5
    5
    Soft tissue infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Staphylococcal infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    1
    0
    2
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Stoma site abscess
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Streptococcal urinary tract infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Subcutaneous abscess
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
         occurrences all number
    1
    4
    5
    8
    Superinfection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Superinfection bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Tick-borne viral encephalitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Tinea capitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea cruris
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tinea infection
         subjects affected / exposed
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
    2 / 3576 (0.06%)
    6 / 3581 (0.17%)
         occurrences all number
    2
    3
    2
    6
    Tinea pedis
         subjects affected / exposed
    4 / 3576 (0.11%)
    3 / 3581 (0.08%)
    13 / 3576 (0.36%)
    5 / 3581 (0.14%)
         occurrences all number
    4
    3
    13
    5
    Tinea versicolour
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    14 / 3576 (0.39%)
    18 / 3581 (0.50%)
    22 / 3576 (0.62%)
    22 / 3581 (0.61%)
         occurrences all number
    15
    18
    25
    22
    Tonsillitis bacterial
         subjects affected / exposed
    5 / 3576 (0.14%)
    6 / 3581 (0.17%)
    5 / 3576 (0.14%)
    9 / 3581 (0.25%)
         occurrences all number
    5
    6
    5
    9
    Tooth abscess
         subjects affected / exposed
    11 / 3576 (0.31%)
    13 / 3581 (0.36%)
    22 / 3576 (0.62%)
    25 / 3581 (0.70%)
         occurrences all number
    12
    13
    23
    26
    Tooth infection
         subjects affected / exposed
    8 / 3576 (0.22%)
    12 / 3581 (0.34%)
    17 / 3576 (0.48%)
    22 / 3581 (0.61%)
         occurrences all number
    10
    12
    20
    24
    Tracheitis
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    1
    3
    4
    Tracheobronchitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    2
    2
    Trichuriasis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tuberculosis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    172 / 3576 (4.81%)
    161 / 3581 (4.50%)
    255 / 3576 (7.13%)
    236 / 3581 (6.59%)
         occurrences all number
    254
    232
    453
    414
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    15 / 3576 (0.42%)
    19 / 3581 (0.53%)
    21 / 3576 (0.59%)
    20 / 3581 (0.56%)
         occurrences all number
    16
    20
    22
    21
    Urethritis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    142 / 3576 (3.97%)
    130 / 3581 (3.63%)
    263 / 3576 (7.35%)
    244 / 3581 (6.81%)
         occurrences all number
    156
    147
    331
    296
    Urinary tract infection bacterial
         subjects affected / exposed
    41 / 3576 (1.15%)
    23 / 3581 (0.64%)
    43 / 3576 (1.20%)
    28 / 3581 (0.78%)
         occurrences all number
    44
    26
    47
    34
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Urinary tract infection staphylococcal
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urinary tract infection viral
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vaginal cellulitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaginal infection
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    9 / 3576 (0.25%)
    6 / 3581 (0.17%)
         occurrences all number
    4
    4
    11
    6
    Vaginitis bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
    0 / 3576 (0.00%)
    5 / 3581 (0.14%)
         occurrences all number
    0
    3
    0
    5
    Varicella
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Viraemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    4 / 3581 (0.11%)
         occurrences all number
    1
    2
    2
    4
    Viral diarrhoea
         subjects affected / exposed
    32 / 3576 (0.89%)
    27 / 3581 (0.75%)
    34 / 3576 (0.95%)
    27 / 3581 (0.75%)
         occurrences all number
    34
    28
    36
    28
    Viral hepatitis carrier
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Viral infection
         subjects affected / exposed
    29 / 3576 (0.81%)
    30 / 3581 (0.84%)
    45 / 3576 (1.26%)
    50 / 3581 (1.40%)
         occurrences all number
    30
    32
    47
    53
    Viral labyrinthitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
    1 / 3576 (0.03%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    2
    1
    2
    Viral pharyngitis
         subjects affected / exposed
    15 / 3576 (0.42%)
    12 / 3581 (0.34%)
    17 / 3576 (0.48%)
    13 / 3581 (0.36%)
         occurrences all number
    18
    12
    20
    13
    Viral rash
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Viral rhinitis
         subjects affected / exposed
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    3
    1
    3
    Viral sinusitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Viral skin infection
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    227 / 3576 (6.35%)
    206 / 3581 (5.75%)
    263 / 3576 (7.35%)
    230 / 3581 (6.42%)
         occurrences all number
    312
    283
    394
    352
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    1
    3
    2
    Vulvovaginal mycotic infection
         subjects affected / exposed
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
    8 / 3576 (0.22%)
    3 / 3581 (0.08%)
         occurrences all number
    6
    4
    9
    5
    Vulvovaginitis
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Wound infection
         subjects affected / exposed
    5 / 3576 (0.14%)
    2 / 3581 (0.06%)
    8 / 3576 (0.22%)
    9 / 3581 (0.25%)
         occurrences all number
    6
    2
    9
    9
    Wound infection bacterial
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Zika virus infection
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    3
    1
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    3
    Acquired mixed hyperlipidaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cachexia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    2
    0
    4
    Calcium metabolism disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Carbohydrate intolerance
         subjects affected / exposed
    5 / 3576 (0.14%)
    7 / 3581 (0.20%)
    8 / 3576 (0.22%)
    14 / 3581 (0.39%)
         occurrences all number
    5
    7
    8
    14
    Central obesity
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Cow's milk intolerance
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Decreased appetite
         subjects affected / exposed
    32 / 3576 (0.89%)
    24 / 3581 (0.67%)
    48 / 3576 (1.34%)
    42 / 3581 (1.17%)
         occurrences all number
    32
    24
    48
    44
    Dehydration
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    3 / 3576 (0.08%)
    4 / 3581 (0.11%)
         occurrences all number
    2
    2
    4
    4
    Diabetes mellitus
         subjects affected / exposed
    31 / 3576 (0.87%)
    34 / 3581 (0.95%)
    61 / 3576 (1.71%)
    57 / 3581 (1.59%)
         occurrences all number
    31
    35
    64
    63
    Diabetes mellitus inadequate control
         subjects affected / exposed
    7 / 3576 (0.20%)
    7 / 3581 (0.20%)
    12 / 3576 (0.34%)
    13 / 3581 (0.36%)
         occurrences all number
    7
    7
    13
    14
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    74 / 3576 (2.07%)
    81 / 3581 (2.26%)
    137 / 3576 (3.83%)
    134 / 3581 (3.74%)
         occurrences all number
    74
    81
    143
    136
    Electrolyte imbalance
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    5 / 3576 (0.14%)
    5 / 3581 (0.14%)
         occurrences all number
    2
    0
    5
    5
    Fluid overload
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Fluid retention
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    1
    2
    2
    Folate deficiency
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    1
    0
    2
    2
    Food intolerance
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Glucose tolerance impaired
         subjects affected / exposed
    12 / 3576 (0.34%)
    16 / 3581 (0.45%)
    24 / 3576 (0.67%)
    27 / 3581 (0.75%)
         occurrences all number
    12
    16
    25
    27
    Gout
         subjects affected / exposed
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
    14 / 3576 (0.39%)
    5 / 3581 (0.14%)
         occurrences all number
    12
    3
    19
    7
    Hyper HDL cholesterolaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Hyperammonaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    5 / 3576 (0.14%)
    1 / 3581 (0.03%)
    19 / 3576 (0.53%)
    8 / 3581 (0.22%)
         occurrences all number
    5
    1
    20
    8
    Hyperchloraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    42 / 3576 (1.17%)
    45 / 3581 (1.26%)
    72 / 3576 (2.01%)
    85 / 3581 (2.37%)
         occurrences all number
    42
    45
    74
    87
    Hyperglycaemia
         subjects affected / exposed
    24 / 3576 (0.67%)
    27 / 3581 (0.75%)
    41 / 3576 (1.15%)
    50 / 3581 (1.40%)
         occurrences all number
    26
    28
    48
    56
    Hyperkalaemia
         subjects affected / exposed
    11 / 3576 (0.31%)
    9 / 3581 (0.25%)
    18 / 3576 (0.50%)
    14 / 3581 (0.39%)
         occurrences all number
    11
    9
    18
    14
    Hyperlipidaemia
         subjects affected / exposed
    21 / 3576 (0.59%)
    12 / 3581 (0.34%)
    31 / 3576 (0.87%)
    26 / 3581 (0.73%)
         occurrences all number
    21
    12
    31
    26
    Hypermagnesaemia
         subjects affected / exposed
    4 / 3576 (0.11%)
    1 / 3581 (0.03%)
    7 / 3576 (0.20%)
    3 / 3581 (0.08%)
         occurrences all number
    4
    1
    8
    4
    Hypernatraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
    0 / 3576 (0.00%)
    4 / 3581 (0.11%)
         occurrences all number
    0
    2
    0
    4
    Hyperproteinaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    6 / 3576 (0.17%)
    17 / 3581 (0.47%)
    13 / 3576 (0.36%)
    22 / 3581 (0.61%)
         occurrences all number
    6
    17
    13
    22
    Hyperuricaemia
         subjects affected / exposed
    8 / 3576 (0.22%)
    10 / 3581 (0.28%)
    14 / 3576 (0.39%)
    18 / 3581 (0.50%)
         occurrences all number
    8
    10
    14
    19
    Hypervitaminosis
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    2 / 3581 (0.06%)
         occurrences all number
    0
    0
    0
    2
    Hypocalcaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    8 / 3581 (0.22%)
         occurrences all number
    0
    1
    3
    8
    Hypochloraemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    2
    1
    Hypoglycaemia
         subjects affected / exposed
    8 / 3576 (0.22%)
    11 / 3581 (0.31%)
    12 / 3576 (0.34%)
    19 / 3581 (0.53%)
         occurrences all number
    8
    13
    13
    24
    Hypokalaemia
         subjects affected / exposed
    10 / 3576 (0.28%)
    15 / 3581 (0.42%)
    24 / 3576 (0.67%)
    28 / 3581 (0.78%)
         occurrences all number
    10
    15
    24
    31
    Hypomagnesaemia
         subjects affected / exposed
    3 / 3576 (0.08%)
    0 / 3581 (0.00%)
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
         occurrences all number
    3
    0
    4
    4
    Hyponatraemia
         subjects affected / exposed
    6 / 3576 (0.17%)
    10 / 3581 (0.28%)
    17 / 3576 (0.48%)
    24 / 3581 (0.67%)
         occurrences all number
    7
    10
    19
    27
    Hypophosphataemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Hypovolaemia
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    11 / 3576 (0.31%)
    10 / 3581 (0.28%)
    14 / 3576 (0.39%)
    15 / 3581 (0.42%)
         occurrences all number
    11
    10
    14
    15
    Increased appetite
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    1 / 3581 (0.03%)
         occurrences all number
    2
    1
    3
    1
    Insulin resistance
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Iron deficiency
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    2
    3
    Lactose intolerance
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Latent tetany
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lipid metabolism disorder
         subjects affected / exposed
    2 / 3576 (0.06%)
    1 / 3581 (0.03%)
    3 / 3576 (0.08%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    1
    4
    3
    Malnutrition
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    3 / 3581 (0.08%)
         occurrences all number
    0
    0
    1
    4
    Metabolic disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Metabolic syndrome
         subjects affected / exposed
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Obesity
         subjects affected / exposed
    2 / 3576 (0.06%)
    0 / 3581 (0.00%)
    6 / 3576 (0.17%)
    3 / 3581 (0.08%)
         occurrences all number
    2
    0
    6
    3
    Overweight
         subjects affected / exposed
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
    2 / 3576 (0.06%)
    2 / 3581 (0.06%)
         occurrences all number
    2
    2
    2
    2
    Periarthritis calcarea
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Plasma protein metabolism disorder
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    0
    0
    1
    Polydipsia
         subjects affected / exposed
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
    0 / 3576 (0.00%)
    1 / 3581 (0.03%)
         occurrences all number
    0
    1
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    17 / 3576 (0.48%)
    21 / 3581 (0.59%)
    35 / 3576 (0.98%)
    34 / 3581 (0.95%)
         occurrences all number
    17
    22
    36
    37
    Underweight
         subjects affected / exposed
    0 / 3576 (0.00%)
    0 / 3581 (0.00%)
    1 / 3576 (0.03%)
    0 / 3581 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin B complex deficiency
         subjects affected / exposed
    1 / 3576 (0.03%)
    1 / 3581 (0.03%)
    2 / 3576 (0.06%)
    3 / 3581 (0.08%)
         occurrences all number
    1
    1
    2
    3
    Vitamin B12 deficiency
         subjects affected / exposed
    4 / 3576 (0.11%)
    4 / 3581 (0.11%)
    8 / 3576 (0.22%)
    11 / 3581 (0.31%)
         occurrences all number
    4
    4
    9
    11
    Vitamin D deficiency
         subjects affected / exposed
    1 / 3576 (0.03%)
    4 / 3581 (0.11%)
    6 / 3576 (0.17%)
    12 / 3581 (0.34%)
         occurrences all number
    1
    4
    6
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Aug 2012
    The main goal of Protocol Amendment 1 was to add a coprimary objective to assess the effect of romosozumab treatment for 12 months followed by denosumab treatment for 12 months compared with placebo followed by denosumab on the subject incidence of new vertebral fracture. This addition reflected the chronic nature of osteoporosis in postmenopausal women requiring long-term treatment and facilitated a more complete assessment of the efficacy of a time-limited exposure to romosozumab in such a clinical context. The following changes resulted from the additional objective: • Study visit schedule, visit procedures, hypotheses, endpoints, and statistical analysis methods were amended. • Sample size was updated from 5600 to 6000 subjects to allow adequate power to assess the effect of the treatment regimens on reduction in nonvertebral fractures at the end of 24 months. • Safety data reporting was amended to present data over the entire duration of the 24-month study period. Other substantive updates were as follows: • amended exclusion criteria to ensure that bone disorders related to presence of disease/disorder or administration of medications did not confound the assessment of efficacy and safety of romosozumab. • removed exclusion criteria of androgen deprivation therapy • clarified excluded treatments during the study • recommended options in instances of intolerance to protocol required calcium and vitamin D supplementation • clarified investigational product administration procedure • removed denosumab PK assessments • added Serum iPTH and Urinary Calcium substudy • removed month 21 visit since it was not critical for the evaluation of the study objectives • added adjudication of specific events by external experts • added alerting procedure for subjects with loss of ≥ 7% BMD at either the spine or the total hip at month 12 • clarified timings of study procedures, assessment of proper anatomic sites, and fasting requirements for blood draws • added acronym (FRAME)
    18 Mar 2013
    The primary goal of Protocol Amendment 2 was is to facilitate enrollment into the Audiology substudy by increasing eligible air-conduction thresholds and airbone gaps. Other substantive updates to the protocol were as follows: • clarified that vitamin D loading dose could be given after 1 week postrandomization if the 1-week window was missed • allowed day 1/baseline lumbar spine DXA scan to be taken with the proximal femur DXA scan during screening • clarified procedures for rescreening subjects who did not initially meet the required serum 25 (OH) vitamin D levels • removed requirement to use doxycycline and tetracycline as the only acceptable labels for the month 2 quadruple label procedure for Bone Biopsy substudy. Instead, the Bone Biopsy Manual was referenced for details on the tetracycline derivative labels that were suitable for the quadruple label procedure in order to provide more flexibility in the case of analysis and sourcing constraints. • specified that subjects in the substudies could be replaced while enrollment into the main study was ongoing • clarified expectations for reporting serious adverse events • changed AMG785 to romosozumab
    15 May 2013
    The primary goal of Protocol Amendment 3 was to include additional assessments for formation of antiromosozumab antibodies at the month 1 and month 3 main study visits to allow a more comprehensive characterization of the antiromosozumab antibody response, as requested by the FDA. Further changes were made to allow participation of a wider range of patients as follows: • lowered age from 60 to 55 (limited to 200 subjects so fracture rate would not be affected) • permitted retesting of serum calcium within the screening window if the initial test indicated an elevated level of serum calcium within 1.1 times the upper limit of normal set by the central laboratory. • revised the protocol-mandated off-treatment times for exclusionary medications Lastly, this amendment clarified expectations for serious adverse event reporting after the protocol-mandated reporting period had ended.
    18 Sep 2013
    The primary goal of Protocol Amendment 4 was 2-fold: • to respond to European Medicines Agency request to add an extension period after completion of the initial 24-month study period in which eligible subjects continued to receive open-label denosumab treatment (60 mg SC Q6M) for an additional 12 months while remaining blinded to their initial treatment assignment. Safety endpoints were added at months 30 and 36. Exploratory efficacy endpoints were added at month 36. The primary analysis period was defined as the 24-month study period (ie, after all subjects had the opportunity to complete the month 24 study visit). • to increase the sample size of the main study based on blinded review of on-study nonvertebral fracture data in which the pooled nonvertebral fracture rate was about 12.5% lower than expected under the original protocol assumptions. The assumption that the incidence rate of new vertebral and nonvertebral fracture in the placebo group was 12.5% lower than the original assumptions led to an assumed 2.1% new vertebral fracture rate and an assumed 3.5% nonvertebral fracture rate in the placebo group during the 12-month double-blind period. Using the revised assumptions, the sample size for the study was increased from 6000 to 6600 subjects. Other substantive updates to the protocol were as follows: • removed details relating to the month 12 and month 24 bone biopsy procedures (referred to Bone Biopsy Manual) • updated summary of exclusion criteria to reflect the exclusion criteria revisions incorporated in Amendment 3 (15 May 2013) • added option for subjects to consent to the PK and the Serum iPTH and Urinary Calcium substudies after day 1 (with back-up samples used for any PK time point that may have been missed due to later consenting) • implemented administrative and editorial changes for greater consistency and accuracy

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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