Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multicenter, International, Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Efficacy, Safety, and Tolerability of Daily Oral Dosing of Tafamidis Meglumine (PF-06291826) 20 mg or 80 mg in Comparison to Placebo in Subjects Diagnosed With Transthyretin Cardiomyopathy (TTR-CM)

    Summary
    EudraCT number
    		 2012-002465-35
    Trial protocol
    		 GB   IT   ES   DE   SE   CZ   NL   BE  
    Global end of trial date
    07 Feb 2018

    Results information
    Results version number
    		 v1
    This version publication date
    16 Feb 2019
    First version publication date
    16 Feb 2019
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B3461028
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01994889
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ATTR-ACT: Other Identifier: Alias Study Number
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of an oral dose of 20 milligrams (mg) or 80 mg tafamidis meglumine soft-gel capsules based on all-cause mortality and on frequency of cardiovascular-related hospitalizations as well as to assess safety and tolerability in comparison to placebo.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Czech Republic: 8
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    Italy: 29
    Country: Number of subjects enrolled
    Japan: 17
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 279
    Worldwide total number of subjects
    441
    EEA total number of subjects
    142
    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)
    42
    From 65 to 84 years
    377
    85 years and over
    22

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Pooled analysis of the tafamidis treatment groups 20 mg and 80 mg was performed in comparison to placebo group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tafamidis 20 mg
    Arm description
    		 Subjects with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTRCM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tafamidis meglumine
    Investigational medicinal product code
    PF-06291826
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    One tafamidis 20 mg capsule + 3 placebo capsules (matched to tafamidis), orally once daily for 30 months.

    Arm title
    		 Tafamidis 80 mg
    Arm description
    		 Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tafamidis meglumine
    Investigational medicinal product code
    PF-06291826
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Tafamidis 80 mg (4 capsules of 20 mg each), orally once daily for 30 months.

    Arm title
    		 Placebo
    Arm description
    		 Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Four placebo capsules (matched to tafamidis), orally once daily for 30 months.

    Number of subjects in period 1
    		Tafamidis 20 mg Tafamidis 80 mg Placebo
    Started
    88
    176
    177
    Completed
    60
    113
    85
    Not completed
    28
    63
    92
         Adverse event, serious fatal
    5
    8
    7
         Organ Transplantation
    1
    5
    5
         Adverse event, non-fatal
    -
    1
    1
         Death
    14
    25
    38
         Adverse event, serious non fatal
    -
    3
    3
         No longer willing to participate
    8
    17
    37
         Cardiac Device Implantation
    -
    2
    -
         Lost to follow-up
    -
    1
    -
         Protocol deviation
    -
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Tafamidis 20 mg
    Reporting group description
    		 Subjects with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTRCM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.

    Reporting group title
    Tafamidis 80 mg
    Reporting group description
    		 Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.

    Reporting group values
    		 Tafamidis 20 mg Tafamidis 80 mg Placebo Total
    Number of subjects
    		 88 176 177 441
    Age categorical
    The intent-to-treat (ITT) analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation ( post baseline hospitalization, study visit, or date of death).
    Units: Subjects
        Adults (18-64 years)
    		 11 16 15 42
        From 65-84 years
    		 74 148 155 377
        85 years and over
    		 3 12 7 22
    Age Continuous
    The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation ( post baseline hospitalization, study visit, or date of death).
    Units: years
        arithmetic mean (standard deviation)
    		 73.3 ( 7.07 ) 75.2 ( 7.24 ) 74.1 ( 6.69 ) -
    Sex: Female, Male
    The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation ( post baseline hospitalization, study visit, or date of death).
    Units: Subjects
        Female
    		 5 18 20 43
        Male
    		 83 158 157 398
    Race (NIH/OMB)
    The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation ( post baseline hospitalization, study visit, or date of death).
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 11 5 18
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 11 26 26 63
        White
    		 75 136 146 357
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 3 0 3
    Ethnicity (NIH/OMB)
    The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation ( post baseline hospitalization, study visit, or date of death).
    Units: Subjects
        Hispanic or Latino
    		 3 4 7 14
        Not Hispanic or Latino
    		 84 171 170 425
        Unknown or Not Reported
    		 1 1 0 2

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Tafamidis 20 mg
    Reporting group description
    		 Subjects with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTRCM genotype received one tafamidis 20 milligram (mg) capsule + 3 placebo capsules (matched to tafamidis) orally once daily for 30 months.

    Reporting group title
    Tafamidis 80 mg
    Reporting group description
    		 Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.

    Subject analysis set title
    Tafamidis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects with variant TTR-CM genotype or wild-type TTR-CM genotype received one tafamidis 20 mg + 3 placebo capsules (matched to tafamidis) or 80 mg (4 capsules of 20 mg each) capsule orally once daily for 30 months.

    Primary: Finkelstein-Schoenfeld Analysis: Hierarchical Combination of All-Cause Mortality and Frequency of Cardiovascular-Related Hospitalizations

    		 Close Top of page
    End point title
    		 Finkelstein-Schoenfeld Analysis: Hierarchical Combination of All-Cause Mortality and Frequency of Cardiovascular-Related Hospitalizations [1]
    End point description
    Number of deaths during the study due to any cause was analyzed by using Finkelstein-Schoenfeld analysis test, which uses a hierarchical comparison of mortality and cardiovascular (CV) related-hospitalization. Participants who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. 'Win' represents a subject doing better based on hierarchical comparison. The intent-to-treat (ITT) analysis set included all participants in the safety population (all randomized participants who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation (post baseline hospitalization, study visit, or date of death).
    End point type
    Primary
    End point timeframe
    Baseline up to Month 30
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    177
    264
    Units: pairwise comparison win
        number (not applicable)
    5071
    8595
    Statistical analysis title
    		 Tafamidis Vs. Placebo
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Finkelstein-Schoenfeld Method
    Confidence interval

    Secondary: All-Cause Mortality

    		 Close Top of page
    End point title
    		 All-Cause Mortality [2]
    End point description
    Number of deaths during the study due to any cause was analyzed. Subjects who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device were handled in the same manner as death. The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation (post baseline hospitalization, study visit, or date of death).
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 30
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    177
    264
    Units: subjects
        Deaths (all causes)
    72
    69
        Heart transplants
    4
    7
        Cardiac Mechanical Assist Devices
    0
    2
    Statistical analysis title
    		 Tafamidis Vs. Placebo
    Statistical analysis description
    Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0259
    Method
    		 Cox proportional hazards model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.698
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.508
         upper limit
    		 0.958

    Secondary: Frequency of Cardiovascular-Related Hospitalizations

    		 Close Top of page
    End point title
    		 Frequency of Cardiovascular-Related Hospitalizations [3]
    End point description
    CV related hospitalizations per year is calculated as subject’s number of CV related hospitalizations upon duration on study in years. The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation (post baseline hospitalization, study visit, or date of death).
    End point type
    Secondary
    End point timeframe
    Baseline to Month 30
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    177
    264
    Units: CV hospitalization per year
        arithmetic mean (standard deviation)
    0.884 ( 1.2032 )
    0.999 ( 2.2777 )
    Statistical analysis title
    		 Tafamidis Vs. Placebo
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Poisson regression analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.6761
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5639
         upper limit
    		 0.8107
    Notes
    [4] - Poisson regression analysis with treatment, TTR Genotype, NYHA Baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA Baseline classification interaction terms as factors adjusted for treatment duration.

    Secondary: Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 30

    		 Close Top of page
    End point title
    		 Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 30 [5]
    End point description
    6MWT is the total distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation (post baseline hospitalization, study visit, or date of death). Here, ‘n’ = Subjects evaluable for this end point at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 30
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    177
    264
    Units: meters
    arithmetic mean (standard deviation)
        Baseline (n=177, 264)
    353.26 ( 125.983 )
    350.55 ( 121.296 )
        Change at Month 30 (n=70, 155)
    -89.67 ( 105.159 )
    -30.46 ( 87.886 )
    Statistical analysis title
    		 Tafamidis Vs. Placebo
    Statistical analysis description
    L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and subject within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed Model Repeated Measures ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    75.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 57.56
         upper limit
    		 93.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.236

    Secondary: Change from Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) at Month 30

    		 Close Top of page
    End point title
    		 Change from Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) at Month 30 [6]
    End point description
    KCCQ: 23-item subject-completed questionnaire for health status and health-related quality of life in subjects with heart failure. Consists of 10 summary scores: physical limitation, symptom stability, symptom frequency, symptom burden, total symptoms (mean of symptom frequency and symptom burden scores), self-efficacy, quality of life, social limitation, clinical summary (mean of physical limitation symptom frequency and symptom burden scores) and overall summary(mean of clinical summary, quality of life and social limitation scores). Each summary score ranged from 0 (min) to 100 (max), higher scores representing greater disability. Total score ranged from 0 to 100, higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. ITT analysis set: all subjects in the safety population who had at least 1 post baseline efficacy evaluation. Here, ‘n’ = Subjects evaluable for this end point at specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 30
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    177
    264
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=177, 264)
    65.898 ( 21.7357 )
    67.274 ( 21.3561 )
        Change at Month 30 (n=84,170)
    -14.637 ( 21.4078 )
    -3.855 ( 19.3075 )
    Statistical analysis title
    		 Tafamidis Vs. Placebo
    Statistical analysis description
    Change at Month 30: Overall Summary
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed Model Repeated Measures ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    13.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.48
         upper limit
    		 17.83
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.13

    Secondary: Number of Subjects With Cardiovascular-Related Mortality

    		 Close Top of page
    End point title
    		 Number of Subjects With Cardiovascular-Related Mortality [7]
    End point description
    Deaths adjudicated as CV-related and indeterminate are reported. Subjects who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation (post baseline hospitalization, study visit, or date of death).
    End point type
    Secondary
    End point timeframe
    Baseline up to Month 30
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    177
    264
    Units: subjects
    63
    64
    Statistical analysis title
    		 Tafamidis Vs.Placebo
    Statistical analysis description
    Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    441
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0383
    Method
    		 Cox proportional hazards model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.691
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.488
         upper limit
    		 0.98

    Secondary: Percentage of Subjects With Stabilized Transthyretin (TTR) at Month 1

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Stabilized Transthyretin (TTR) at Month 1 [8]
    End point description
    TTR stabilization is a measure of the degree of stabilization afforded the TTR molecule by tafamidis. The ITT analysis set included all subjects in the safety population (all randomized subjects who received at least 1 dose of double-blind medication) who had at least 1 post baseline efficacy evaluation (post baseline hospitalization, study visit, or date of death). Here, ‘Number analyzed’ = Subjects evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Month 1
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: All patients receiving active medication (Tafamidis 20mg and Tafamidis 80 mg) are included in the pooled analysis
    End point values
    		 Placebo Tafamidis
    Number of subjects analysed
    170
    245
    Units: percentage of subjects
        number (not applicable)
    3.5
    86.1
    Statistical analysis title
    		 Tafamidis Vs.Placebo
    Comparison groups
    Placebo v Tafamidis
    Number of subjects included in analysis
    415
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after last dose of study drug (Month 31)
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event. Analysis performed on safety population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Tafamidis 20 mg
    Reporting group description
    		 Participants with variant transthyretin cardiomyopathy (TTR-CM) genotype or wild-type TTRCM genotype received one tafamidis 20 milligram (mg) capsule orally once daily for 30 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received 4 placebo capsules matched to tafamidis orally once daily for 30 months.

    Reporting group title
    Tafamidis 80 mg
    Reporting group description
    		 Participants with variant TTR-CM genotype or wild-type TTR-CM genotype received tafamidis 80 mg (4 capsules of 20 mg each) orally once daily for 30 months.

    Serious adverse events
    		 Tafamidis 20 mg Placebo Tafamidis 80 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    66 / 88 (75.00%)
    140 / 177 (79.10%)
    133 / 176 (75.57%)
         number of deaths (all causes)
    23
    72
    49
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraductal papilloma of breast
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular neoplasm
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 9
    0 / 11
    General physical health deterioration
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device site haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    9 / 88 (10.23%)
    34 / 177 (19.21%)
    24 / 176 (13.64%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 34
    0 / 24
         deaths causally related to treatment / all
    0 / 9
    0 / 34
    0 / 24
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spermatocele
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Choking
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 88 (2.27%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 177 (2.26%)
    6 / 176 (3.41%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary toxicity
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Stress
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device connection issue
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anticoagulation drug level below therapeutic
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood sodium decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcus test positive
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    5 / 88 (5.68%)
    5 / 177 (2.82%)
    9 / 176 (5.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal foreign body
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Skin abrasion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Tendon rupture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasoplegia syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Familial amyloidosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    7 / 88 (7.95%)
    8 / 177 (4.52%)
    11 / 176 (6.25%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 19
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    5 / 176 (2.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac amyloidosis
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 4
    Cardiac arrest
         subjects affected / exposed
    1 / 88 (1.14%)
    6 / 177 (3.39%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 6
    0 / 2
    Cardiac failure
         subjects affected / exposed
    16 / 88 (18.18%)
    39 / 177 (22.03%)
    34 / 176 (19.32%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 61
    0 / 50
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    0 / 6
    Cardiac failure acute
         subjects affected / exposed
    4 / 88 (4.55%)
    17 / 177 (9.60%)
    23 / 176 (13.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 28
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    15 / 88 (17.05%)
    32 / 177 (18.08%)
    20 / 176 (11.36%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 46
    0 / 31
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    3 / 88 (3.41%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 88 (1.14%)
    6 / 177 (3.39%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial depression
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systolic dysfunction
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 88 (2.27%)
    7 / 177 (3.95%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 88 (0.00%)
    10 / 177 (5.65%)
    6 / 176 (3.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uraemic encephalopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    3 / 88 (3.41%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutrophilia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 88 (3.41%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 88 (3.41%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tongue disorder
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cardiac cirrhosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathic ulcer
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    9 / 88 (10.23%)
    15 / 177 (8.47%)
    13 / 176 (7.39%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 22
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 88 (3.41%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cystitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrotising soft tissue infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    6 / 88 (6.82%)
    12 / 177 (6.78%)
    13 / 176 (7.39%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pneumonia legionella
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 88 (3.41%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Septic arthritis staphylococcal
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Serratia infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 88 (0.00%)
    6 / 177 (3.39%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    2 / 88 (2.27%)
    6 / 177 (3.39%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Fluid retention
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tafamidis 20 mg Placebo Tafamidis 80 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 88 (97.73%)
    171 / 177 (96.61%)
    170 / 176 (96.59%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    4 / 88 (4.55%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    5
    4
    9
    Acrochordon
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Bladder neoplasm
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Cancer pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Haemangioma of skin
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Malignant melanoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Melanocytic naevus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Neoplasm
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Neoplasm skin
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Ocular neoplasm
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Prostate cancer
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    3
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    1
    0
    2
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    5 / 176 (2.84%)
         occurrences all number
    0
    4
    6
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Aortic dilatation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Aortic stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Arteriosclerosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Bleeding varicose vein
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    1
    Deep vein thrombosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Embolism
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Haematoma
         subjects affected / exposed
    2 / 88 (2.27%)
    8 / 177 (4.52%)
    6 / 176 (3.41%)
         occurrences all number
    2
    9
    6
    Haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Hypertension
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences all number
    1
    4
    3
    Hypotension
         subjects affected / exposed
    11 / 88 (12.50%)
    17 / 177 (9.60%)
    19 / 176 (10.80%)
         occurrences all number
    12
    18
    22
    Jugular vein distension
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Lymphoedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Orthostatic hypotension
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    8 / 176 (4.55%)
         occurrences all number
    2
    5
    10
    Pallor
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Peripheral venous disease
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Thrombosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Varicophlebitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Varicose vein
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 88 (12.50%)
    11 / 177 (6.21%)
    16 / 176 (9.09%)
         occurrences all number
    16
    17
    20
    Atrophy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Chest discomfort
         subjects affected / exposed
    3 / 88 (3.41%)
    8 / 177 (4.52%)
    8 / 176 (4.55%)
         occurrences all number
    3
    9
    8
    Chest pain
         subjects affected / exposed
    3 / 88 (3.41%)
    8 / 177 (4.52%)
    7 / 176 (3.98%)
         occurrences all number
    3
    9
    7
    Chills
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    3
    Condition aggravated
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Cyst rupture
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Decreased activity
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Discomfort
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Disease progression
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Early satiety
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    2
    3
    2
    Effusion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    0
    10
    1
    Facial pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    0
    Fatigue
         subjects affected / exposed
    16 / 88 (18.18%)
    33 / 177 (18.64%)
    29 / 176 (16.48%)
         occurrences all number
    23
    48
    33
    Feeling abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Feeling cold
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Gait disturbance
         subjects affected / exposed
    4 / 88 (4.55%)
    11 / 177 (6.21%)
    4 / 176 (2.27%)
         occurrences all number
    4
    11
    4
    General physical health deterioration
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    4 / 176 (2.27%)
         occurrences all number
    4
    1
    4
    Generalised oedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Ill-defined disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Impaired healing
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    1
    Implant site haematoma
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    2
    1
    0
    Implant site pain
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    1
    Inflammation
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    0
    1
    4
    Influenza like illness
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Malaise
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences all number
    1
    5
    2
    Mass
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Oedema
         subjects affected / exposed
    7 / 88 (7.95%)
    20 / 177 (11.30%)
    11 / 176 (6.25%)
         occurrences all number
    7
    22
    22
    Oedema peripheral
         subjects affected / exposed
    17 / 88 (19.32%)
    31 / 177 (17.51%)
    29 / 176 (16.48%)
         occurrences all number
    19
    42
    42
    Pain
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    6 / 176 (3.41%)
         occurrences all number
    1
    2
    6
    Peripheral swelling
         subjects affected / exposed
    2 / 88 (2.27%)
    7 / 177 (3.95%)
    6 / 176 (3.41%)
         occurrences all number
    3
    7
    7
    Pseudocyst
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences all number
    2
    4
    3
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Temperature intolerance
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Haemorrhagic cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Dust allergy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hypersensitivity
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Type IV hypersensitivity reaction
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Social circumstances
    Immobile
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 88 (2.27%)
    7 / 177 (3.95%)
    6 / 176 (3.41%)
         occurrences all number
    2
    7
    7
    Breast engorgement
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Breast enlargement
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Breast mass
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Breast pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Breast swelling
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Breast tenderness
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    5 / 176 (2.84%)
         occurrences all number
    1
    3
    5
    Cervix disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    0
    3
    2
    Genital rash
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Gynaecomastia
         subjects affected / exposed
    4 / 88 (4.55%)
    6 / 177 (3.39%)
    9 / 176 (5.11%)
         occurrences all number
    4
    6
    9
    Nipple pain
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    1
    3
    1
    Pelvic pain
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Oedema genital
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Penile haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatomegaly
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Scrotal oedema
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Acute respiratory failure
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Asthma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Atelectasis
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    0
    3
    3
    Bronchial disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis chronic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchospasm
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Cheyne-Stokes respiration
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    1
    Cough
         subjects affected / exposed
    16 / 88 (18.18%)
    30 / 177 (16.95%)
    20 / 176 (11.36%)
         occurrences all number
    23
    35
    27
    Dyspnoea
         subjects affected / exposed
    21 / 88 (23.86%)
    51 / 177 (28.81%)
    27 / 176 (15.34%)
         occurrences all number
    26
    69
    38
    Dyspnoea exertional
         subjects affected / exposed
    5 / 88 (5.68%)
    13 / 177 (7.34%)
    10 / 176 (5.68%)
         occurrences all number
    5
    16
    11
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 177 (2.82%)
    3 / 176 (1.70%)
         occurrences all number
    0
    7
    4
    Dyspnoea at rest
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Emphysema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    2 / 88 (2.27%)
    14 / 177 (7.91%)
    12 / 176 (6.82%)
         occurrences all number
    3
    22
    12
    Haemoptysis
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    2
    3
    3
    Hypoxia
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    1
    3
    2
    Hyperventilation
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngeal disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Laryngeal erythema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Increased upper airway secretion
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Lung disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    0
    0
    4
    Lung infiltration
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Nasal dryness
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Nasal mucosal disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    0
    4
    4
    Orthopnoea
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    5 / 176 (2.84%)
         occurrences all number
    0
    4
    7
    Painful respiration
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Pleural effusion
         subjects affected / exposed
    8 / 88 (9.09%)
    31 / 177 (17.51%)
    12 / 176 (6.82%)
         occurrences all number
    11
    42
    16
    Pneumomediastinum
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pleuritic pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumothorax
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    2
    Productive cough
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    7 / 176 (3.98%)
         occurrences all number
    2
    2
    7
    Pulmonary congestion
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Pulmonary hypertension
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Pulmonary mass
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    2
    0
    3
    Pulmonary oedema
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    0 / 176 (0.00%)
         occurrences all number
    1
    4
    0
    Rales
         subjects affected / exposed
    3 / 88 (3.41%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    3
    3
    2
    Reflux laryngitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory distress
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory failure
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Respiratory tract congestion
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    2
    2
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Rhonchi
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    0
    4
    1
    Sinus congestion
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 88 (2.27%)
    6 / 177 (3.39%)
    8 / 176 (4.55%)
         occurrences all number
    2
    10
    9
    Sneezing
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Sputum retention
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Vasomotor rhinitis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    2
    1
    0
    Vocal cord dysfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Wheezing
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    2
    3
    1
    Dysphonia
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    2
    2
    1
    Psychiatric disorders
    Acrophobia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Adjustment disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Anxiety
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    8 / 176 (4.55%)
         occurrences all number
    1
    6
    8
    Agitation
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Cardiovascular somatic symptom disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Confusional state
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences all number
    2
    4
    3
    Delirium
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    1
    3
    3
    Depressed mood
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Depression
         subjects affected / exposed
    6 / 88 (6.82%)
    8 / 177 (4.52%)
    7 / 176 (3.98%)
         occurrences all number
    6
    10
    7
    Disorientation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Dysphemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Insomnia
         subjects affected / exposed
    12 / 88 (13.64%)
    22 / 177 (12.43%)
    20 / 176 (11.36%)
         occurrences all number
    13
    27
    23
    Major depression
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Mental status changes
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Nightmare
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Organic brain syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Panic attack
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Persecutory delusion
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Stress
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Product issues
    Device computer issue
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Device dislocation
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Device inappropriate shock delivery
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Device loosening
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Device malfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Device stimulation issue
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Cholecystitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Cholelithiasis
         subjects affected / exposed
    4 / 88 (4.55%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    4
    2
    0
    Cholestasis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    1
    1
    2
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hepatic congestion
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    4 / 176 (2.27%)
         occurrences all number
    2
    2
    4
    Hepatic pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Hepatitis acute
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hepatomegaly
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    1
    1
    3
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Jaundice
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Jaundice cholestatic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Portal vein thrombosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    3
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    0
    4
    1
    Anticoagulation drug level below therapeutic
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Arterial bruit
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    0
    1
    3
    Bence Jones protein urine present
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Blood albumin decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    4 / 88 (4.55%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    4
    1
    4
    Blood chloride decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Blood creatine increased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Blood creatinine abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 88 (3.41%)
    8 / 177 (4.52%)
    9 / 176 (5.11%)
         occurrences all number
    4
    8
    9
    Blood glucose increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Blood lactic acid increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Blood potassium abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    4 / 176 (2.27%)
         occurrences all number
    1
    5
    4
    Blood potassium increased
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    0 / 176 (0.00%)
         occurrences all number
    0
    4
    0
    Blood pressure decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure systolic decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Blood sodium decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 177 (2.82%)
    1 / 176 (0.57%)
         occurrences all number
    0
    5
    1
    Blood urea increased
         subjects affected / exposed
    3 / 88 (3.41%)
    5 / 177 (2.82%)
    8 / 176 (4.55%)
         occurrences all number
    3
    5
    8
    Blood uric acid increased
         subjects affected / exposed
    3 / 88 (3.41%)
    5 / 177 (2.82%)
    8 / 176 (4.55%)
         occurrences all number
    3
    5
    8
    Blood urine present
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Body temperature decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Breath sounds abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac murmur
         subjects affected / exposed
    2 / 88 (2.27%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences all number
    2
    4
    3
    Crystal urine present
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Drug level above therapeutic
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Ejection fraction decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 177 (2.82%)
    1 / 176 (0.57%)
         occurrences all number
    0
    5
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 88 (3.41%)
    11 / 177 (6.21%)
    9 / 176 (5.11%)
         occurrences all number
    3
    11
    9
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Heart rate decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Heart rate increased
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Heart rate irregular
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Human epidermal growth factor receptor decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Human rhinovirus test positive
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Inflammatory marker increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    International normalised ratio decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    6
    4
    4
    Liver function test abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Liver function test increased
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    5 / 176 (2.84%)
         occurrences all number
    2
    2
    5
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Occult blood positive
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Optic nerve cup/disc ratio increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Oxygen saturation abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Protein urine present
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Prothrombin time prolonged
         subjects affected / exposed
    3 / 88 (3.41%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    3
    1
    3
    Pulmonary function test decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Pulse absent
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Red blood cell count decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Thyroid function test abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroxine decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Transaminases increased
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    0
    4
    2
    Troponin increased
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences all number
    1
    4
    2
    Urobilinogen urine increased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Venous pressure jugular abnormal
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Venous pressure jugular increased
         subjects affected / exposed
    4 / 88 (4.55%)
    9 / 177 (5.08%)
    4 / 176 (2.27%)
         occurrences all number
    5
    12
    4
    Vitamin D decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Waist circumference increased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Weight decreased
         subjects affected / exposed
    6 / 88 (6.82%)
    18 / 177 (10.17%)
    8 / 176 (4.55%)
         occurrences all number
    6
    19
    8
    Weight increased
         subjects affected / exposed
    7 / 88 (7.95%)
    12 / 177 (6.78%)
    13 / 176 (7.39%)
         occurrences all number
    8
    12
    20
    White blood cell count decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Animal bite
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Arthropod sting
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Back injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bone fissure
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Bursa injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Chest injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Compression fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    6 / 88 (6.82%)
    5 / 177 (2.82%)
    11 / 176 (6.25%)
         occurrences all number
    6
    6
    14
    Craniocerebral injury
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Electric shock
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Eye contusion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Face injury
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Facial bones fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Fall
         subjects affected / exposed
    24 / 88 (27.27%)
    40 / 177 (22.60%)
    38 / 176 (21.59%)
         occurrences all number
    36
    69
    50
    Femoral neck fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Femur fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Hand fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Head injury
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    5 / 176 (2.84%)
         occurrences all number
    1
    2
    5
    Hip fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Incision site erythema
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Incision site pain
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    2
    Injury
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Joint injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    0
    1
    3
    Laceration
         subjects affected / exposed
    3 / 88 (3.41%)
    3 / 177 (1.69%)
    6 / 176 (3.41%)
         occurrences all number
    3
    3
    6
    Ligament injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    2
    2
    1
    Limb injury
         subjects affected / exposed
    2 / 88 (2.27%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    2
    4
    1
    Lip injury
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Lower limb fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Metal poisoning
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle injury
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle rupture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Overdose
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Pelvic fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Periorbital haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Post procedural swelling
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    4
    2
    Rib fracture
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    2
    4
    2
    Scar
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Seroma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Skeletal injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    5 / 176 (2.84%)
         occurrences all number
    1
    5
    5
    Skin injury
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal column injury
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal compression fracture
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Subdural haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    3
    Sunburn
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Suture related complication
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Tooth fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Wound
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    4 / 176 (2.27%)
         occurrences all number
    0
    1
    4
    Wrist fracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Skin wound
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hydrocele
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Phimosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Accelerated idioventricular rhythm
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Angina pectoris
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    2
    1
    3
    Aortic valve incompetence
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Aortic valve stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Arrhythmia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    5 / 176 (2.84%)
         occurrences all number
    0
    1
    5
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    0
    6
    5
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    13 / 88 (14.77%)
    31 / 177 (17.51%)
    28 / 176 (15.91%)
         occurrences all number
    17
    49
    35
    Atrial flutter
         subjects affected / exposed
    5 / 88 (5.68%)
    12 / 177 (6.78%)
    8 / 176 (4.55%)
         occurrences all number
    7
    16
    11
    Atrial tachycardia
         subjects affected / exposed
    3 / 88 (3.41%)
    7 / 177 (3.95%)
    6 / 176 (3.41%)
         occurrences all number
    5
    8
    6
    Atrial thrombosis
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    1
    4
    1
    Atrioventricular block
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Atrioventricular block complete
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    0
    3
    2
    Atrioventricular block first degree
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    3 / 176 (1.70%)
         occurrences all number
    2
    2
    3
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    1
    0
    2
    Bradyarrhythmia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    2
    3
    2
    Bundle branch block right
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Cardiac amyloidosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Cardiac aneurysm
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Cardiac failure
         subjects affected / exposed
    18 / 88 (20.45%)
    33 / 177 (18.64%)
    20 / 176 (11.36%)
         occurrences all number
    35
    62
    29
    Cardiac failure acute
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    3 / 176 (1.70%)
         occurrences all number
    0
    6
    3
    Cardiac failure chronic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 88 (2.27%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences all number
    2
    5
    3
    Cardiogenic shock
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Cardiomegaly
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiomyopathy
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    2
    1
    0
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Coronary artery disease
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Cyanosis
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Diastolic dysfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatojugular reflux
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    2
    1
    4
    Intracardiac thrombus
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Left ventricular failure
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Low cardiac output syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 88 (1.14%)
    6 / 177 (3.39%)
    2 / 176 (1.14%)
         occurrences all number
    1
    7
    2
    Palpitations
         subjects affected / exposed
    2 / 88 (2.27%)
    8 / 177 (4.52%)
    4 / 176 (2.27%)
         occurrences all number
    2
    11
    4
    Pericardial effusion
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    2
    2
    2
    Pulmonary valve incompetence
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Rhythm idioventricular
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Right ventricular failure
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Sinus arrest
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Sinus node dysfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Tachyarrhythmia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    0
    Tachycardia
         subjects affected / exposed
    3 / 88 (3.41%)
    1 / 177 (0.56%)
    6 / 176 (3.41%)
         occurrences all number
    3
    1
    6
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences all number
    1
    4
    2
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    0
    3
    3
    Ventricular fibrillation
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 88 (2.27%)
    6 / 177 (3.39%)
    5 / 176 (2.84%)
         occurrences all number
    3
    6
    8
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    0
    4
    2
    Altered state of consciousness
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Amnesia
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    4 / 176 (2.27%)
         occurrences all number
    2
    3
    4
    Anosmia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Aphasia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Aphonia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Asterixis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Balance disorder
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    15 / 176 (8.52%)
         occurrences all number
    3
    2
    16
    Brain injury
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Burning sensation
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    2
    0
    2
    Carotid artery aneurysm
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    5 / 88 (5.68%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    5
    6
    4
    Cognitive disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Dementia
         subjects affected / exposed
    2 / 88 (2.27%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    2
    4
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    16 / 88 (18.18%)
    32 / 177 (18.08%)
    25 / 176 (14.20%)
         occurrences all number
    20
    36
    31
    Dizziness postural
         subjects affected / exposed
    0 / 88 (0.00%)
    7 / 177 (3.95%)
    4 / 176 (2.27%)
         occurrences all number
    0
    8
    5
    Dysarthria
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    3 / 176 (1.70%)
         occurrences all number
    1
    4
    3
    Encephalopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Focal dyscognitive seizures
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Head discomfort
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Headache
         subjects affected / exposed
    1 / 88 (1.14%)
    11 / 177 (6.21%)
    9 / 176 (5.11%)
         occurrences all number
    1
    13
    11
    Hemiparesis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Hypersomnia
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Hypoaesthesia
         subjects affected / exposed
    5 / 88 (5.68%)
    6 / 177 (3.39%)
    4 / 176 (2.27%)
         occurrences all number
    5
    6
    4
    Hypotonia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Incoherent
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Intention tremor
         subjects affected / exposed
    3 / 88 (3.41%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    3
    0
    1
    Lacunar infarction
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    0
    3
    3
    Loss of consciousness
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Memory impairment
         subjects affected / exposed
    4 / 88 (4.55%)
    4 / 177 (2.26%)
    5 / 176 (2.84%)
         occurrences all number
    5
    4
    5
    Mental impairment
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Myelopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Nerve compression
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Neurodegenerative disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    4 / 88 (4.55%)
    12 / 177 (6.78%)
    3 / 176 (1.70%)
         occurrences all number
    4
    14
    4
    Orthostatic intolerance
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 88 (1.14%)
    6 / 177 (3.39%)
    5 / 176 (2.84%)
         occurrences all number
    1
    6
    6
    Parkinson's disease
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Parkinsonism
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Parosmia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Polyneuropathy
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    2
    Poor quality sleep
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    2 / 88 (2.27%)
    6 / 177 (3.39%)
    3 / 176 (1.70%)
         occurrences all number
    2
    6
    3
    Radiculopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 177 (2.82%)
    1 / 176 (0.57%)
         occurrences all number
    0
    6
    1
    Sciatica
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    2
    Senile dementia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Seizure
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Sensorimotor disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    5 / 88 (5.68%)
    11 / 177 (6.21%)
    5 / 176 (2.84%)
         occurrences all number
    8
    14
    6
    Somnolence
         subjects affected / exposed
    1 / 88 (1.14%)
    6 / 177 (3.39%)
    2 / 176 (1.14%)
         occurrences all number
    1
    6
    2
    Tension headache
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Tinel's sign
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Tremor
         subjects affected / exposed
    0 / 88 (0.00%)
    8 / 177 (4.52%)
    0 / 176 (0.00%)
         occurrences all number
    0
    8
    0
    Tunnel vision
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Visual field defect
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 88 (5.68%)
    13 / 177 (7.34%)
    10 / 176 (5.68%)
         occurrences all number
    5
    13
    10
    Anaemia macrocytic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Coagulopathy
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Haemorrhagic disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hypoprothrombinaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    0
    3
    4
    Leukocytosis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Leukopenia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    1
    Macrocytosis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Microcytic anaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophilia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Normocytic anaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Splenic infarction
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Splenomegaly
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    6 / 176 (3.41%)
         occurrences all number
    1
    7
    7
    Polycythaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    1
    Deafness
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    0
    0
    3
    Deafness neurosensory
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Ear discomfort
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Ear disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Ear haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Ear pain
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Eustachian tube dysfunction
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Excessive cerumen production
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hypoacusis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Tinnitus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Vertigo
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    5 / 176 (2.84%)
         occurrences all number
    1
    5
    5
    Vertigo positional
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Blepharitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Blepharochalasis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Cataract
         subjects affected / exposed
    3 / 88 (3.41%)
    2 / 177 (1.13%)
    8 / 176 (4.55%)
         occurrences all number
    3
    2
    8
    Chalazion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Diplopia
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    3
    2
    0
    Dry eye
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 177 (2.82%)
    4 / 176 (2.27%)
         occurrences all number
    0
    5
    5
    Eye disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Eye haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Eye oedema
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Eye pruritus
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Eyelid bleeding
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Glaucoma
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Lacrimal structural disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Macular degeneration
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    0
    Macular fibrosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Neovascular age-related macular degeneration
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Ocular vascular disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Optic atrophy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Papilloedema
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Photopsia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pterygium
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Retinal tear
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Scleral discolouration
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    5 / 176 (2.84%)
         occurrences all number
    2
    4
    5
    Visual acuity reduced
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Visual impairment
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    3
    1
    4
    Vitreous detachment
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    3 / 88 (3.41%)
    7 / 177 (3.95%)
    6 / 176 (3.41%)
         occurrences all number
    3
    7
    6
    Abdominal distension
         subjects affected / exposed
    6 / 88 (6.82%)
    5 / 177 (2.82%)
    7 / 176 (3.98%)
         occurrences all number
    6
    5
    10
    Abdominal hernia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    3 / 88 (3.41%)
    6 / 177 (3.39%)
    8 / 176 (4.55%)
         occurrences all number
    3
    6
    8
    Abdominal pain lower
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    5 / 176 (2.84%)
         occurrences all number
    1
    7
    9
    Abdominal rigidity
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Anal incontinence
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Ascites
         subjects affected / exposed
    7 / 88 (7.95%)
    9 / 177 (5.08%)
    6 / 176 (3.41%)
         occurrences all number
    12
    12
    7
    Barrett's oesophagus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    2
    Bowel movement irregularity
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Colitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Constipation
         subjects affected / exposed
    14 / 88 (15.91%)
    30 / 177 (16.95%)
    25 / 176 (14.20%)
         occurrences all number
    15
    36
    25
    Dental caries
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    10 / 88 (11.36%)
    39 / 177 (22.03%)
    22 / 176 (12.50%)
         occurrences all number
    11
    52
    25
    Diverticulum
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    1
    Diverticulum intestinal
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    1
    3
    0
    Dry mouth
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    2 / 176 (1.14%)
         occurrences all number
    1
    5
    2
    Duodenal ulcer
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    3 / 88 (3.41%)
    5 / 177 (2.82%)
    4 / 176 (2.27%)
         occurrences all number
    3
    6
    5
    Dysphagia
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    4 / 176 (2.27%)
         occurrences all number
    2
    3
    4
    Enteritis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Eructation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Faeces soft
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Flatulence
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    8 / 176 (4.55%)
         occurrences all number
    3
    3
    9
    Frequent bowel movements
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    0
    0
    3
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Gastric disorder
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    1
    3
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Gastritis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    0
    2
    3
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 88 (6.82%)
    7 / 177 (3.95%)
    0 / 176 (0.00%)
         occurrences all number
    6
    7
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Haematochezia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    0
    4
    5
    Hiatus hernia
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    2
    Ileus
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Impaired gastric emptying
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Inguinal hernia
         subjects affected / exposed
    5 / 88 (5.68%)
    3 / 177 (1.69%)
    5 / 176 (2.84%)
         occurrences all number
    6
    3
    5
    Large intestine polyp
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    1
    4
    1
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Melaena
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Mouth haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    9 / 88 (10.23%)
    36 / 177 (20.34%)
    20 / 176 (11.36%)
         occurrences all number
    11
    53
    21
    Oesophageal mass
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Oesophageal spasm
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Oesophagitis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Oral disorder
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Pancreatic cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Pancreatic mass
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Periodontal disease
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pneumatosis intestinalis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Proctalgia
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    1
    0
    2
    Rectal polyp
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Retching
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Salivary gland calculus
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Salivary gland enlargement
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth loss
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    2
    2
    Umbilical hernia
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    7 / 88 (7.95%)
    16 / 177 (9.04%)
    6 / 176 (3.41%)
         occurrences all number
    7
    19
    6
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Actinic keratosis
         subjects affected / exposed
    3 / 88 (3.41%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    3
    0
    3
    Alopecia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    0
    0
    3
    Blister
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    3
    2
    Decubitus ulcer
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    0 / 176 (0.00%)
         occurrences all number
    1
    4
    0
    Cold sweat
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Dermatitis contact
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Diabetic foot
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    4 / 176 (2.27%)
         occurrences all number
    0
    3
    6
    Eczema
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Eczema nummular
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Erythema
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    2 / 176 (1.14%)
         occurrences all number
    1
    5
    2
    Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hair colour changes
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    4 / 176 (2.27%)
         occurrences all number
    2
    0
    5
    Hypertrophic scar
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Myxoid cyst
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Lentigo
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Nail dystrophy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Nail ridging
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Neurodermatitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Onychomalacia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Petechiae
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Photodermatosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Pigmentation disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Post inflammatory pigmentation change
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Pruritus
         subjects affected / exposed
    4 / 88 (4.55%)
    15 / 177 (8.47%)
    12 / 176 (6.82%)
         occurrences all number
    5
    16
    14
    Purpura
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    3 / 88 (3.41%)
    12 / 177 (6.78%)
    6 / 176 (3.41%)
         occurrences all number
    3
    16
    6
    Rash erythematous
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Rash pruritic
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Skin disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    0
    5
    4
    Skin atrophy
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Skin ulcer
         subjects affected / exposed
    3 / 88 (3.41%)
    1 / 177 (0.56%)
    7 / 176 (3.98%)
         occurrences all number
    3
    1
    9
    Stasis dermatitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Swelling face
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Transient acantholytic dermatosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Xanthoma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Papule
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Xeroderma
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Urticaria
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 88 (5.68%)
    18 / 177 (10.17%)
    8 / 176 (4.55%)
         occurrences all number
    6
    19
    11
    Azotaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Calculus bladder
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Chronic kidney disease
         subjects affected / exposed
    4 / 88 (4.55%)
    6 / 177 (3.39%)
    6 / 176 (3.41%)
         occurrences all number
    4
    7
    7
    Dysuria
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    3
    3
    1
    End stage renal disease
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Haematuria
         subjects affected / exposed
    10 / 88 (11.36%)
    15 / 177 (8.47%)
    8 / 176 (4.55%)
         occurrences all number
    13
    17
    9
    Incontinence
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Micturition urgency
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    2
    3
    1
    Neurogenic bladder
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Nocturia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Oliguria
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Polyuria
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Proteinuria
         subjects affected / exposed
    0 / 88 (0.00%)
    5 / 177 (2.82%)
    2 / 176 (1.14%)
         occurrences all number
    0
    5
    2
    Renal cyst
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    4 / 176 (2.27%)
         occurrences all number
    1
    2
    4
    Renal impairment
         subjects affected / exposed
    2 / 88 (2.27%)
    8 / 177 (4.52%)
    5 / 176 (2.84%)
         occurrences all number
    2
    8
    5
    Renal disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Renal failure
         subjects affected / exposed
    5 / 88 (5.68%)
    7 / 177 (3.95%)
    8 / 176 (4.55%)
         occurrences all number
    6
    7
    10
    Renal infarct
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Renal injury
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Renal mass
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Stress urinary incontinence
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Ureterolithiasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary bladder polyp
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    1
    2
    2
    Urinary retention
         subjects affected / exposed
    2 / 88 (2.27%)
    12 / 177 (6.78%)
    6 / 176 (3.41%)
         occurrences all number
    2
    12
    6
    Urinary tract pain
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Urine flow decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Urethral stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    3 / 176 (1.70%)
         occurrences all number
    0
    2
    3
    Hypogonadism
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    5 / 88 (5.68%)
    10 / 177 (5.65%)
    12 / 176 (6.82%)
         occurrences all number
    6
    10
    12
    Thyroid mass
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 88 (9.09%)
    20 / 177 (11.30%)
    17 / 176 (9.66%)
         occurrences all number
    11
    27
    19
    Arthritis
         subjects affected / exposed
    4 / 88 (4.55%)
    1 / 177 (0.56%)
    4 / 176 (2.27%)
         occurrences all number
    4
    1
    4
    Back pain
         subjects affected / exposed
    9 / 88 (10.23%)
    23 / 177 (12.99%)
    17 / 176 (9.66%)
         occurrences all number
    9
    29
    18
    Bone pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Bursitis
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    0
    3
    6
    Chest wall haematoma
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Chondrocalcinosis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    3 / 176 (1.70%)
         occurrences all number
    0
    0
    5
    Enthesopathy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Exostosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    0
    5
    0
    Foot deformity
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    3
    1
    Fracture pain
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Gouty tophus
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    0 / 176 (0.00%)
         occurrences all number
    1
    4
    0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Haemarthrosis
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Joint swelling
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    0 / 176 (0.00%)
         occurrences all number
    2
    7
    0
    Intervertebral disc space narrowing
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Knee deformity
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Limb discomfort
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    4 / 176 (2.27%)
         occurrences all number
    2
    1
    4
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    3 / 176 (1.70%)
         occurrences all number
    0
    2
    5
    Metatarsalgia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Muscle atrophy
         subjects affected / exposed
    2 / 88 (2.27%)
    5 / 177 (2.82%)
    2 / 176 (1.14%)
         occurrences all number
    2
    5
    3
    Muscle contracture
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    10 / 88 (11.36%)
    14 / 177 (7.91%)
    15 / 176 (8.52%)
         occurrences all number
    13
    19
    15
    Muscle twitching
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    2 / 88 (2.27%)
    12 / 177 (6.78%)
    5 / 176 (2.84%)
         occurrences all number
    2
    12
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    3 / 176 (1.70%)
         occurrences all number
    1
    3
    3
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 88 (1.14%)
    4 / 177 (2.26%)
    1 / 176 (0.57%)
         occurrences all number
    1
    5
    1
    Musculoskeletal pain
         subjects affected / exposed
    3 / 88 (3.41%)
    11 / 177 (6.21%)
    13 / 176 (7.39%)
         occurrences all number
    4
    12
    17
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    3 / 176 (1.70%)
         occurrences all number
    2
    1
    3
    Neck pain
         subjects affected / exposed
    4 / 88 (4.55%)
    5 / 177 (2.82%)
    3 / 176 (1.70%)
         occurrences all number
    4
    5
    3
    Myalgia
         subjects affected / exposed
    5 / 88 (5.68%)
    2 / 177 (1.13%)
    5 / 176 (2.84%)
         occurrences all number
    7
    2
    5
    Osteoarthritis
         subjects affected / exposed
    2 / 88 (2.27%)
    6 / 177 (3.39%)
    9 / 176 (5.11%)
         occurrences all number
    2
    7
    10
    Osteopenia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Osteoporosis
         subjects affected / exposed
    2 / 88 (2.27%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    2
    3
    1
    Pain in extremity
         subjects affected / exposed
    6 / 88 (6.82%)
    20 / 177 (11.30%)
    27 / 176 (15.34%)
         occurrences all number
    7
    25
    32
    Pain in jaw
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    5 / 176 (2.84%)
         occurrences all number
    0
    0
    7
    Spinal column stenosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    3 / 176 (1.70%)
         occurrences all number
    0
    2
    3
    Spondylolisthesis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    3
    Tendonitis
         subjects affected / exposed
    0 / 88 (0.00%)
    4 / 177 (2.26%)
    2 / 176 (1.14%)
         occurrences all number
    0
    5
    2
    Synovial cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    2
    Trigger finger
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    1
    0
    1
    Tenosynovitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    2 / 176 (1.14%)
         occurrences all number
    0
    3
    3
    Arthritis bacterial
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bacteraemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bacterial abdominal infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bacterial infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Body tinea
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Bronchiolitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    7 / 88 (7.95%)
    19 / 177 (10.73%)
    21 / 176 (11.93%)
         occurrences all number
    8
    20
    24
    Candida infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Candiduria
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    6 / 88 (6.82%)
    10 / 177 (5.65%)
    6 / 176 (3.41%)
         occurrences all number
    6
    11
    6
    Chronic sinusitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Cystitis
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    5 / 176 (2.84%)
         occurrences all number
    2
    0
    5
    Device related infection
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Diverticulitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Ear infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Endocarditis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Enteritis infectious
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Erysipelas
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Eye infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Folliculitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal skin infection
         subjects affected / exposed
    2 / 88 (2.27%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    2
    2
    0
    Gas gangrene
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Gastritis viral
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    5 / 176 (2.84%)
         occurrences all number
    1
    4
    5
    Gastroenteritis viral
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    0
    3
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Genitourinary tract infection
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    1
    5
    0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 88 (0.00%)
    6 / 177 (3.39%)
    6 / 176 (3.41%)
         occurrences all number
    0
    7
    9
    Hordeolum
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Impetigo
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Infected cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Infected dermal cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Infected skin ulcer
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    4 / 88 (4.55%)
    6 / 177 (3.39%)
    7 / 176 (3.98%)
         occurrences all number
    5
    6
    8
    Kidney infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Labyrinthitis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Localised infection
         subjects affected / exposed
    2 / 88 (2.27%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    2
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    0 / 176 (0.00%)
         occurrences all number
    0
    4
    0
    Lung infection
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    2
    0
    1
    Molluscum contagiosum
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    7 / 88 (7.95%)
    17 / 177 (9.60%)
    14 / 176 (7.95%)
         occurrences all number
    9
    23
    17
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Onychomycosis
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Parotitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Periodontitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Periorbital cellulitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Pneumonia
         subjects affected / exposed
    4 / 88 (4.55%)
    7 / 177 (3.95%)
    12 / 176 (6.82%)
         occurrences all number
    7
    8
    15
    Pneumonia bacterial
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pneumonia viral
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Post procedural infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Pulpitis dental
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Pyuria
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    1
    2
    1
    Rhinitis
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    2 / 176 (1.14%)
         occurrences all number
    0
    1
    2
    Sepsis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Septic shock
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    4 / 88 (4.55%)
    1 / 177 (0.56%)
    10 / 176 (5.68%)
         occurrences all number
    4
    1
    12
    Skin infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth abscess
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    3
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    0
    1
    1
    Tracheitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Tracheobronchitis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 88 (7.95%)
    16 / 177 (9.04%)
    17 / 176 (9.66%)
         occurrences all number
    7
    18
    19
    Urinary tract infection
         subjects affected / exposed
    7 / 88 (7.95%)
    25 / 177 (14.12%)
    15 / 176 (8.52%)
         occurrences all number
    10
    33
    18
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Wound infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    0
    0
    2
    Gingivitis
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    2
    Metabolism and nutrition disorders
    Adult failure to thrive
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Cachexia
         subjects affected / exposed
    3 / 88 (3.41%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    3
    3
    2
    Decreased appetite
         subjects affected / exposed
    8 / 88 (9.09%)
    25 / 177 (14.12%)
    14 / 176 (7.95%)
         occurrences all number
    9
    25
    15
    Dehydration
         subjects affected / exposed
    3 / 88 (3.41%)
    4 / 177 (2.26%)
    4 / 176 (2.27%)
         occurrences all number
    3
    4
    4
    Diabetes mellitus
         subjects affected / exposed
    1 / 88 (1.14%)
    5 / 177 (2.82%)
    1 / 176 (0.57%)
         occurrences all number
    1
    5
    1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Fluid overload
         subjects affected / exposed
    11 / 88 (12.50%)
    27 / 177 (15.25%)
    18 / 176 (10.23%)
         occurrences all number
    12
    44
    31
    Fluid retention
         subjects affected / exposed
    3 / 88 (3.41%)
    15 / 177 (8.47%)
    5 / 176 (2.84%)
         occurrences all number
    5
    18
    7
    Gout
         subjects affected / exposed
    10 / 88 (11.36%)
    29 / 177 (16.38%)
    17 / 176 (9.66%)
         occurrences all number
    10
    34
    22
    Hyperammonaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    1
    3
    2
    Hyperkalaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    10 / 177 (5.65%)
    8 / 176 (4.55%)
         occurrences all number
    1
    10
    10
    Hyperlactacidaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    3 / 88 (3.41%)
    7 / 177 (3.95%)
    9 / 176 (5.11%)
         occurrences all number
    3
    7
    10
    Hypervolaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    2 / 176 (1.14%)
         occurrences all number
    1
    0
    3
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    2
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Hypochloraemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 177 (0.00%)
    0 / 176 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Hypokalaemia
         subjects affected / exposed
    8 / 88 (9.09%)
    19 / 177 (10.73%)
    14 / 176 (7.95%)
         occurrences all number
    8
    28
    15
    Hypomagnesaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    1 / 176 (0.57%)
         occurrences all number
    1
    1
    1
    Hyponatraemia
         subjects affected / exposed
    2 / 88 (2.27%)
    10 / 177 (5.65%)
    8 / 176 (4.55%)
         occurrences all number
    3
    12
    8
    Hypoproteinaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Hypovolaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0
    Iron deficiency
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 177 (1.13%)
    1 / 176 (0.57%)
         occurrences all number
    0
    2
    1
    Malnutrition
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    2 / 176 (1.14%)
         occurrences all number
    0
    3
    2
    Metabolic acidosis
         subjects affected / exposed
    0 / 88 (0.00%)
    3 / 177 (1.69%)
    1 / 176 (0.57%)
         occurrences all number
    0
    3
    1
    Metabolic alkalosis
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Metabolic disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 177 (0.00%)
    1 / 176 (0.57%)
         occurrences all number
    0
    0
    1
    Protein deficiency
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 177 (1.13%)
    0 / 176 (0.00%)
         occurrences all number
    1
    2
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    0
    4
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 177 (0.56%)
    0 / 176 (0.00%)
         occurrences all number
    1
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Apr 2014
    Amended the week 2 follow-up to allow for flexibility.Expanded 30 month vital status determination to include transplant status.
    26 Feb 2015
    Added clarification for Hepatitis and HIV exclusion.
    24 May 2016
    Incorporated the discontinuation of enrollment of subjects with wild-type genotype in order to increase the numbers of subjects with variant genotype. Redefined the baseline groupings for New York Heart Association (NYHA) functional classification that will be used for efficacy analyses, grouping subjects with NYHA Class I and II together to be compared against NYHA Class III.

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

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

    European Medicines Agency © 1995-Fri Apr 19 00:06:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA