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   43973   clinical trials with a EudraCT protocol, of which   7311   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 Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

    Summary
    EudraCT number
    2020-005226-28
    Trial protocol
    FR   DE   IT  
    Global end of trial date
    21 Mar 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Nov 2023
    First version publication date
    23 Nov 2023
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    D8110C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04516746
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Karlebyhusentren, B674 Astraallen, Södertälje, Sweden, SE-151 85
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.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
    21 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate the efficacy and assess the safety, tolerability and reactogenicity (for substudy only) of 2 intramuscular (IM) doses of AZD1222 compared to saline placebo for the prevention of coronavirus disease-2019 (COVID-19).
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements, and the AstraZeneca policy on Bioethics.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Aug 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Chile: 2206
    Country: Number of subjects enrolled
    Peru: 1470
    Country: Number of subjects enrolled
    United States: 28774
    Worldwide total number of subjects
    32450
    EEA total number of subjects
    0
    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)
    25195
    From 65 to 84 years
    7136
    85 years and over
    119

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    This Phase III randomized study was conducted in adult participants who were healthy or had medically stable chronic diseases and were at increased risk for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) acquisition and coronavirus disease-2019 (COVID-19). One participant was enrolled at 2 sites and excluded from all analysis sets.

    Pre-assignment
    Screening details
    Study had a screening period (14 days), followed by a treatment and follow-up period (up to 760 days). A total of 32450 participants were randomized in a 2:1 ratio to receive AZD1222 or placebo. The first participants randomized in each age group in the United States of America participated in a substudy to assess immunogenicity and reactogenicity.

    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, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    AZD1222
    Arm description
    Participants were randomized to receive 2 IM doses of 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.
    Arm type
    Experimental

    Investigational medicinal product name
    AZD1222
    Investigational medicinal product code
    ChAdOx1 nCoV-19
    Other name
    Vaxzevria
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    AZD1222 5*10^10 vp was administered on Days 1 and 29.

    Arm title
    Placebo
    Arm description
    Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo matching with AZD1222 was administered on Days 1 and 29.

    Number of subjects in period 1
    AZD1222 Placebo
    Started
    21634
    10816
    Participants who received first dose
    21583
    10797
    Participants who received second dose
    20770
    9954
    Completed
    16099
    7213
    Not completed
    5535
    3603
         Consent withdrawn by subject
    1946
    1696
         Physician decision
    10
    8
         Adverse event, non-fatal
    -
    1
         Death
    62
    32
         Randomized but not Treated
    51
    19
         Unspecified
    35
    16
         Lost to follow-up
    3431
    1831

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    AZD1222
    Reporting group description
    Participants were randomized to receive 2 IM doses of 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

    Reporting group title
    Placebo
    Reporting group description
    Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

    Reporting group values
    AZD1222 Placebo Total
    Number of subjects
    21634 10816 32450
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    50.2 ± 15.92 50.2 ± 15.86 -
    Gender Categorical
    Units: Subjects
        Female
    9603 4797 14400
        Male
    12031 6019 18050
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    4787 2456 7243
        Not Hispanic or Latino
    16506 8217 24723
        Not reported
    293 127 420
        Unknown
    48 16 64
    Race
    Units: Subjects
        Multiple
    513 258 771
        White
    17100 8534 25634
        Black or African American
    1798 899 2697
        Asian
    947 483 1430
        American Indian or Alaska Native
    855 430 1285
        Native Hawaiian or Other Pacific Islander
    60 21 81
        Not reported
    260 138 398
        Unknown
    101 53 154

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    AZD1222
    Reporting group description
    Participants were randomized to receive 2 IM doses of 5*10^10 viral particles (vp) (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

    Reporting group title
    Placebo
    Reporting group description
    Participants were randomized to receive 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

    Primary: Number of Participants With Binary Response

    Close Top of page
    End point title
    Number of Participants With Binary Response
    End point description
    A binary response, whereby a participant with negative serostatus at baseline is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case. The primary efficacy analysis was performed once approximately 150 events meeting the primary efficacy outcome measure definition had occurred across the AZD1222 and placebo groups. The fully vaccinated analysis set (FVS) included all participants in the full analysis set (FAS) who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
    End point type
    Primary
    End point timeframe
    From 15 days post second dose up to data cut-off date (DCO) of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    17662
    8550
    Units: participants
    73
    130
    Statistical analysis title
    Treatment ratio in binary response
    Statistical analysis description
    The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    26212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    73.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    65.34
         upper limit
    80.47

    Primary: Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With Adverse Events (AEs) Post Each Dose of Study Intervention [1]
    End point description
    An AE is the development of any untoward medical occurrence in a clinical study participant administered medicinal product and which does not necessarily have a causal relationship with this medicinal product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The safety analysis set included all participants who received at least 1 dose of study intervention. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 28 days post second dose of study intervention, approximately 57 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    21587
    10792
    Units: participants
        After first dose (n= 21587, 10792)
    5736
    1926
        After second dose (n= 20773, 9947)
    5074
    1797
        After any dose (n= 21587, 10792)
    8771
    3201
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Throughout the Study

    Close Top of page
    End point title
    Number of Participants With Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE), and Adverse Event of Special Interest (AESI) Throughout the Study [2]
    End point description
    An SAE is an AE occurring during any study phase that fulfils 1 or more of the following criteria: death; immediately life-threatening; in-participant hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital abnormality or birth defect; an important medical event. AESIs were events of scientific and medical interest specific to the further understanding of the study intervention safety profile and required close monitoring and rapid communication by the investigators to the sponsor. MAAEs are defined as AEs leading to medically-attended visits that were not routine visits for physical examination or vaccination, such as an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Different follow-up time between AZD1222 and Placebo groups (20223 versus 3893 participant years). The safety analysis set.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 2 years of follow-up post first dose or study discontinuation or receipt of non-study COVID-19 vaccination, a maximum of approximately 760 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    21587
    10793
    Units: participants
        SAEs
    621
    136
        MAAEs
    4750
    1256
        AESIs
    2516
    591
    No statistical analyses for this end point

    Primary: Number of Participants With Local and Systemic Solicited AEs in the Substudy Only

    Close Top of page
    End point title
    Number of Participants With Local and Systemic Solicited AEs in the Substudy Only [3]
    End point description
    Solicited AEs are local or systemic predefined events for assessment of reactogenicity. Solicited AEs were collected in a e-Diary only for participants in the substudy. The safety analysis set included all participants who received at least 1 dose of study intervention. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 7 days post each dose of study intervention, approximately 14 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistical analysis was performed for the primary endpoint.
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    2037
    1013
    Units: participants
        Solicited local AEs: After 1st dose(n=1830,920)
    1250
    173
        Solicited local AEs: After 2nd dose(n=1829,908)
    977
    120
        Solicited local AEs: After any dose(n=1944,979)
    1440
    239
        Solicited systemic AEs: After 1st dose(n=1842,924)
    1191
    415
        Solicited systemic AEs: After 2nd dose(n=1821,905)
    862
    314
        Solicited systemic AEs: After any dose(n=1947,980)
    1395
    519
    No statistical analyses for this end point

    Secondary: Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study

    Close Top of page
    End point title
    Number of Participants With First Post-intervention Response for SARS-CoV-2 Nucleocapsid Antibodies Post Second Dose of Study
    End point description
    The incidence of the first post-intervention response (negative at baseline to positive post intervention with study intervention) for SARS-CoV-2 nucleocapsid antibodies occurring ≥ 15 days post second dose of study intervention (key secondary endpoint). The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    17662
    8550
    Units: participants
    156
    202
    Statistical analysis title
    Treatment difference: Nucleocapsid antibodies
    Statistical analysis description
    The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    26212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    64.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    56.05
         upper limit
    71.03

    Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With First COVID-19 Symptomatic Illness Using Centers for Disease Control and Prevention (CDC) Criteria Post Second Dose of Study Intervention
    End point description
    The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using CDC criteria. Participant must present with at least 1 of the following symptoms per CDC criteria: fever, shortness of breath, difficulty breathing, chills, cough, fatigue, muscle aches, body aches, headache, new loss of taste, new loss of smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea. The FVS included all participants in the full analysis set who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    17662
    8550
    Units: participants
    95
    145
    Statistical analysis title
    Treatment difference: COVID-19 symptomatic illness
    Statistical analysis description
    The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    26212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    69.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    60.68
         upper limit
    76.57

    Secondary: Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With First Symptomatic COVID-19 Regardless of Evidence of Prior SARS-CoV-2 Infection Post Second Dose of Study Intervention
    End point description
    The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention regardless of evidence of prior SARS-CoV-2 infection (key secondary endpoint). The FVS regardless of prior SARS-COV-2 infection included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    18563
    9031
    Units: participants
    76
    135
    Statistical analysis title
    Treatment difference: First symptomatic COVID-19
    Statistical analysis description
    The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    27594
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    73.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    65.13
         upper limit
    80.13

    Secondary: Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With First COVID-19 Symptomatic Illness Using University of Oxford-Defined Symptom Criteria Post Second Dose of Study Intervention
    End point description
    The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford-defined symptom criteria: new onset of fever (> 100 °Fahrenheit [> 37.8 °Celsius]), cough, shortness of breath, or anosmia/ageusia. The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    17662
    8550
    Units: participants
    86
    136
    Statistical analysis title
    Treatment difference: COVID-19 symptomatic illness
    Statistical analysis description
    The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    26212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    70.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    61.62
         upper limit
    77.64

    Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post Second Dose of Study Intervention
    End point description
    The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 15 days post second dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death (key secondary endpoint). The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    17662
    8550
    Units: participants
    0
    8
    Statistical analysis title
    Treatment difference: COVID-19 symptomatic illness
    Statistical analysis description
    The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor [age group at informed consent] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    26212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression exact conditional
    Parameter type
    Vaccine efficacy
    Point estimate
    100
    Confidence interval
         level
    97.5%
         sides
    1-sided
         lower limit
    71.62
         upper limit
    -

    Secondary: Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With COVID-19 Severe or Critical Symptomatic Illness Post First Dose of Study Intervention
    End point description
    The incidence of SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring post first dose of study intervention. The severity of COVID-19 was evaluated in participants with symptoms of COVID-19. Following are the findings regarding severe of critical symptomatic COVID-19: clinical signs at rest indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; and death. The FAS included all randomized participants who received at least 1 dose of study intervention, irrespective of their protocol adherence and continued participation in the study. Only participants who are seronegative at baseline were analyzed.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    20589
    10300
    Units: participants
    5
    16
    Statistical analysis title
    Treatment difference: COVID-19 symptomatic illness
    Statistical analysis description
    The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    30889
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    84.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    58.97
         upper limit
    94.5

    Secondary: Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With COVID-19-Related Emergency Department Visits Post Second Dose of Study Intervention
    End point description
    The incidence of COVID-19-related emergency department visits occurring ≥ 15 days post second dose of study intervention (key secondary endpoint). The FVS included all participants in the FAS who were seronegative at baseline, received 2 doses of study intervention, and who remained on-study 15 days after their second dose without having had a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.
    End point type
    Secondary
    End point timeframe
    From 15 days post second dose up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of 17 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    17662
    8550
    Units: participants
    1
    9
    Statistical analysis title
    Treatment difference: Emergency department visits
    Statistical analysis description
    The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor [age group at informed consent] as covariates, and log of the follow up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    26212
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005
    Method
    Poisson regression with robust variance
    Parameter type
    Vaccine efficacy
    Point estimate
    94.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    58.98
         upper limit
    99.34

    Secondary: Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay

    Close Top of page
    End point title
    Geometric Mean Titers (GMTs) for SARS-CoV-2 Spike (S) and Receptor Binding Domain (RBD) Antibodies as Measured by Meso Scale Discovery (MSD) Serology Assay
    End point description
    The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Days 15, 29, 43, 57, 90, 180, 360, and 730
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    2008
    1002
    Units: arbitrary units per milliliter (AU/mL)
    geometric mean (confidence interval 95%)
        S Antibody Titer: Day 1 (n=2008, 1002)
    53.18 (50.37 to 56.14)
    54.68 (50.10 to 59.69)
        S Antibody Titer: Day 15 (n=1897, 949)
    1820.10 (1696.48 to 1952.72)
    53.47 (48.88 to 58.50)
        S Antibody Titer: Day 29 (n=1428, 708)
    5782.09 (5389.88 to 6202.84)
    53.64 (47.98 to 59.97)
        S Antibody Titer: Day 43 (n=1809, 899)
    24105.87 (22945.04 to 25325.44)
    58.15 (52.68 to 64.18)
        S Antibody Titer: Day 57 (n=1760, 829)
    19488.64 (18521.81 to 20505.92)
    58.30 (52.35 to 64.94)
        S Antibody Titer: Day 90 (n=1675, 643)
    14583.30 (13839.22 to 15367.38)
    87.51 (74.78 to 102.42)
        S Antibody Titer: Day 180 (n=1217, 147)
    7483.04 (6911.35 to 8102.02)
    266.47 (161.19 to 440.49)
        S Antibody Titer: Day 360 (n=874, 47)
    6686.81 (5779.74 to 7736.24)
    1268.45 (489.80 to 3284.98)
        S Antibody Titer: Day 730 (n=276, 22)
    186727.78 (154395.93 to 225830.20)
    19093.94 (5685.04 to 64129.44)
        RBD Antibody Titer: Day 1 (n=2008, 1002)
    133.6 (129.1 to 138.4)
    138.9 (130.9 to 147.3)
        RBD Antibody Titer: Day 15 (n=1897, 949)
    965.0 (897.0 to 1038.1)
    138.6 (130.5 to 147.1)
        RBD Antibody Titer: Day 29 (n=1427, 708)
    5176.6 (4794.8 to 5588.9)
    143.0 (132.4 to 154.3)
        RBD Antibody Titer: Day 43 (n=1809, 899)
    29351.9 (27875.6 to 30906.4)
    145.7 (136.0 to 156.1)
        RBD Antibody Titer: Day 57 (n=1760, 829)
    23840.6 (22614.3 to 25133.3)
    151.6 (140.3 to 163.8)
        RBD Antibody Titer: Day 90 (n=1675, 643)
    17499.9 (16559.1 to 18494.1)
    192.6 (171.0 to 217.0)
        RBD Antibody Titer: Day 180 (n=1217, 147)
    8333.1 (7647.9 to 9079.7)
    481.6 (314.8 to 736.7)
        RBD Antibody Titer: Day 360 (n=874, 47)
    7499.2 (6417.7 to 8763.1)
    1912.3 (839.0 to 4358.5)
        RBD Antibody Titer: Day 730 (n=276, 22)
    276381.8 (227665.9 to 335521.9)
    19319.4 (5290.3 to 70551.9)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay

    Close Top of page
    End point title
    Geometric Mean Fold Rise (GMFR) for SARS-CoV-2 S and RBD Antibodies as Measured by MSD Serology Assay
    End point description
    The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 43, 57, 90, 180, 360, and 730
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    1885
    943
    Units: ratio
    geometric mean (confidence interval 95%)
        S Antibody Titer: Day 15 (n=1885, 943)
    34.28 (31.87 to 36.86)
    0.97 (0.94 to 1.00)
        S Antibody Titer: Day 29 (n=1420, 706)
    108.35 (99.95 to 117.45)
    0.92 (0.87 to 0.96)
        S Antibody Titer: Day 43 (n=1797, 894)
    455.38 (425.71 to 487.12)
    1.08 (1.02 to 1.14)
        S Antibody Titer: Day 57 (n=1746, 823)
    373.44 (348.12 to 400.60)
    1.10 (1.02 to 1.19)
        S Antibody Titer: Day 90 (n=1664, 638)
    274.05 (255.01 to 294.50)
    1.61 (1.41 to 1.85)
        S Antibody Titer: Day 180 (n=1207, 146)
    138.44 (125.37 to 152.88)
    3.33 (2.07 to 5.37)
        S Antibody Titer: Day 360 (n=866, 46)
    121.12 (102.89 to 142.58)
    17.44 (6.75 to 45.07)
        S Antibody Titer: Day 730 (n=273, 22)
    3506.74 (2808.52 to 4378.55)
    295.66 (89.07 to 981.35)
        RBD Antibody Titer: Day 15 (n=1885, 943)
    7.24 (6.76 to 7.76)
    1.00 (0.98 to 1.02)
        RBD Antibody Titer: Day 29 (n=1419, 706)
    39.01 (36.10 to 42.17)
    1.01 (0.98 to 1.03)
        RBD Antibody Titer: Day 43 (n=1797, 894)
    219.94 (207.28 to 233.37)
    1.05 (1.01 to 1.09)
        RBD Antibody Titer: Day 57 (n=1746, 823)
    178.61 (167.97 to 189.92)
    1.10 (1.04 to 1.16)
        RBD Antibody Titer: Day 90 (n=1664, 638)
    130.46 (122.53 to 138.89)
    1.41 (1.27 to 1.57)
        RBD Antibody Titer: Day 180 (n=1207, 146)
    61.69 (56.27 to 67.62)
    3.13 (2.11 to 4.65)
        RBD Antibody Titer: Day 360 (n=866, 46)
    53.91 (45.86 to 63.37)
    11.18 (4.91 to 25.45)
        RBD Antibody Titer: Day 730 (n=273, 22)
    2103.65 (1706.88 to 2592.64)
    106.35 (29.93 to 377.87)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay

    Close Top of page
    End point title
    Percentage of Participants With Seroresponse to the S and RBD Antigens of AZD1222 as Measured by MSD Serology Assay
    End point description
    The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to the S and RBD antigens of AZD1222 as measured by MSD serology assay is reported. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 43, 57, 90, 180, 360, and 730
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    1885
    943
    Units: percentage of participants
    number (not applicable)
        S Antibody Titer: Day 15 (n=1885, 943)
    89.8
    1.1
        S Antibody Titer: Day 29 (n=1420, 706)
    97.1
    1.6
        S Antibody Titer: Day 43 (n=1797, 894)
    99.4
    2.5
        S Antibody Titer: Day 57 (n=1746, 823)
    99.3
    3.2
        S Antibody Titer: Day 90 (n=1664, 638)
    99.3
    8.9
        S Antibody Titer: Day 180 (n=1207, 146)
    98.3
    23.3
        S Antibody Titer: Day 360 (n=866, 46)
    96.1
    54.3
        S Antibody Titer: Day 730 (n=273, 22)
    100.0
    90.9
        RBD Antibody Titer: Day 15 (n=1885, 943)
    61.3
    0.4
        RBD Antibody Titer: Day 29 (n=1419, 706)
    92.2
    1.0
        RBD Antibody Titer: Day 43 (n=1797, 894)
    98.8
    2.0
        RBD Antibody Titer: Day 57 (n=1746, 823)
    98.7
    2.6
        RBD Antibody Titer: Day 90 (n=1664, 638)
    98.6
    7.7
        RBD Antibody Titer: Day 180 (n=1207, 146)
    96.3
    22.6
        RBD Antibody Titer: Day 360 (n=866, 46)
    89.8
    50.0
        RBD Antibody Titer: Day 730 (n=273, 22)
    99.3
    86.4
    No statistical analyses for this end point

    Secondary: GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

    Close Top of page
    End point title
    GMTs for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay
    End point description
    The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titer/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titer, where 'n' is the number of participants with titer information. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Days 15, 29, 43, 57, 90, 180, and 360
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    1943
    973
    Units: AU/mL
    geometric mean (confidence interval 95%)
        Day 1 (n=1943, 973)
    20.6 (20.3 to 20.9)
    21.4 (20.7 to 22.0)
        Day 15 (n=1747, 920)
    41.7 (39.3 to 44.2)
    21.7 (20.9 to 22.4)
        Day 29 (n=1227, 682)
    65.9 (60.8 to 71.4)
    23.0 (21.8 to 24.3)
        Day 43 (n=1642, 876)
    221.3 (208.4 to 235.0)
    22.6 (21.6 to 23.5)
        Day 57 (n=1469, 777)
    251.8 (235.7 to 269.0)
    23.3 (22.1 to 24.6)
        Day 90 (n=60, 21)
    206.1 (150.3 to 282.6)
    37.5 (15.0 to 94.1)
        Day 180 (n=283, 127)
    112.9 (90.4 to 141.0)
    51.3 (37.4 to 70.4)
        Day 360 (n=27, 14)
    265.7 (94.0 to 751.1)
    46.3 (20.1 to 106.4)
    No statistical analyses for this end point

    Secondary: GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay

    Close Top of page
    End point title
    GMFR for SARS-CoV-2 Neutralizing Antibodies as Measured by Pseudo-neutralization Assay
    End point description
    The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. GMFR was calculated as anti-logarithm of Σ (log base 2 transformed (post-vaccination titer/ pre-vaccination titer)/n). Where 'n' is the number of participants with titer information. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 43, 57, 90, 180, and 360
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    1705
    896
    Units: ratio
    geometric mean (confidence interval 95%)
        Day 15 (n=1705, 896)
    2.03 (1.92 to 2.15)
    1.01 (0.99 to 1.03)
        Day 29 (n=1200, 670)
    3.24 (2.99 to 3.50)
    1.07 (1.02 to 1.11)
        Day 43 (n=1597, 854)
    10.91 (10.27 to 11.58)
    1.05 (1.01 to 1.08)
        Day 57 (n=1432, 759)
    12.32 (11.54 to 13.16)
    1.08 (1.03 to 1.14)
        Day 90 (n=60, 20)
    9.95 (7.33 to 13.51)
    1.94 (0.74 to 5.09)
        Day 180 (n=274, 123)
    5.37 (4.30 to 6.71)
    2.22 (1.65 to 3.00)
        Day 360 (n=26, 14)
    12.64 (4.31 to 37.11)
    2.31 (1.01 to 5.32)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay

    Close Top of page
    End point title
    Percentage of Participants With Seroresponse to SARS-CoV-2 Neutralizing Antibodies of AZD1222 as Measured by Pseudo-neutralization Assay
    End point description
    The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. The percentage of participants with a post-intervention seroresponse (≥ 4-fold rise in titers from baseline value to 28 days post each dose) to SARS-CoV-2 neutralizing antibodies of AZD1222 as measured by pseudo-neutralization assay is reported. The immunogenicity analysis population included all participants in the safety analysis set who had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response. Only participants included in the substudy were analyzed. Here, 'n' is number of participants analyzed at specific time point.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 43, 57, 90, 180, and 360
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    1705
    896
    Units: percentage of participants
    number (not applicable)
        Day 15 (n=1705, 896)
    24.8
    0.3
        Day 29 (n=1200, 670)
    41.1
    1.8
        Day 43 (n=1597, 854)
    84.4
    1.9
        Day 57 (n=1432, 759)
    84.4
    2.2
        Day 90 (n=60, 20)
    83.3
    10.0
        Day 180 (n=274, 123)
    51.5
    22.0
        Day 360 (n=26, 14)
    53.8
    28.6
    No statistical analyses for this end point

    Secondary: Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention

    Close Top of page
    End point title
    Number of Participants With COVID-19 Symptomatic Illness Post First Dose of Study Intervention
    End point description
    The incidence of SARS-CoV-2 RT-PCR-positive symptomatic illness occurring post first dose of study intervention. The FAS included all randomized participants who received at least 1 dose of study intervention, irrespective of their protocol adherence and continued participation in the study. Only participants who are seronegative at baseline were analyzed.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to DCO of 05 March 2021 or study discontinuation or unblinding or receipt of non-study COVID-19 vaccination, up to a maximum of approximately 27 weeks
    End point values
    AZD1222 Placebo
    Number of subjects analysed
    20589
    10300
    Units: participants
    287
    303
    Statistical analysis title
    Treatment difference: COVID-19 symptomatic illness
    Statistical analysis description
    The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).
    Comparison groups
    AZD1222 v Placebo
    Number of subjects included in analysis
    30889
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Vaccine efficacy
    Point estimate
    54.47
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    46.48
         upper limit
    61.26

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    For SAEs: From first dose of study intervention up to 2 years of follow-up post first dose, a maximum of approximately 760 days; For non-serious AEs: From first dose of study intervention up to 28 days post each dose, a maximum of approximately 57 days.
    Adverse event reporting additional description
    The safety analysis set included all participants who received at least 1 dose of study intervention. Adverse events data reported for double-blind period only. All-cause mortality data reported for overall period (double-blind period and unblinded period).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received 2 IM doses of placebo matching with AZD1222 on Days 1 and 29.

    Reporting group title
    AZD1222
    Reporting group description
    Participants received 2 IM doses of 5*10^10 vp (nominal, ± 1.5*10^10 vp) AZD1222 on Days 1 and 29.

    Serious adverse events
    Placebo AZD1222
    Total subjects affected by serious adverse events
         subjects affected / exposed
    467 / 10793 (4.33%)
    1039 / 21587 (4.81%)
         number of deaths (all causes)
    33
    62
         number of deaths resulting from adverse events
    33
    62
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    2 / 10793 (0.02%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acral lentiginous melanoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute monocytic leukaemia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    3 / 10793 (0.03%)
    7 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Astrocytoma
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Borderline mucinous tumour of ovary
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    7 / 10793 (0.06%)
    11 / 21587 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer male
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemangioma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma stage IV
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 10793 (0.02%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Choroid melanoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon cancer stage IV
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage III
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ependymoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    7 / 10793 (0.06%)
    13 / 21587 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 10793 (0.02%)
    7 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary breast neoplasm
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Huerthle cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hormone receptor positive breast cancer
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lentigo maligna
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucoepidermoid carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant anorectal neoplasm
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 10793 (0.02%)
    9 / 21587 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of pleura
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of thymus
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant splenic neoplasm
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    2 / 10793 (0.02%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma stage III
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma stage III
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma stage II
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oligodendroglioma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer stage III
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    22 / 10793 (0.20%)
    32 / 21587 (0.15%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    1 / 10793 (0.01%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage I
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    7 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma stage IV
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Triple negative breast cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoma uterus
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seminoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Signet-ring cell carcinoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinonasal papilloma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 10793 (0.00%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular seminoma (pure)
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal melanocytoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 10793 (0.04%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dilatation
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial haemorrhage
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 10793 (0.03%)
    13 / 21587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Embolism
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery haematoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ruptured ectopic pregnancy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    3 / 10793 (0.03%)
    15 / 21587 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical incompetence
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature delivery
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stillbirth
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site haematoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    2 / 10793 (0.02%)
    7 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    4 / 10793 (0.04%)
    7 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 7
    Drowning
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural failure
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Swelling face
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 10793 (0.02%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 10793 (0.02%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast haematoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 10793 (0.01%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Chronic respiratory failure
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic paralysis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    3 / 10793 (0.03%)
    11 / 21587 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Asphyxia
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    2 / 10793 (0.02%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Laryngeal leukoplakia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal obstruction
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 10793 (0.00%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    7 / 10793 (0.06%)
    29 / 21587 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 32
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary granuloma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 10793 (0.00%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar II disorder
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    5 / 10793 (0.05%)
    5 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Delirium
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizoaffective disorder
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    3 / 10793 (0.03%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    3 / 10793 (0.03%)
    7 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 10793 (0.02%)
    8 / 21587 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    3 / 10793 (0.03%)
    9 / 21587 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    3 / 10793 (0.03%)
    8 / 21587 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis alcoholic
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Precancerous cells present
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate increased
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Accidental overdose
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired encephalocele
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    3 / 10793 (0.03%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cartilage injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical peritonitis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    2 / 10793 (0.02%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    6 / 10793 (0.06%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    4 / 10793 (0.04%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medication error
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypobarism
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haematoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 10793 (0.01%)
    5 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Patella fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural swelling
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reactive gastropathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 10793 (0.01%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondral fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 10793 (0.02%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Toxicity to various agents
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Soft tissue injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 10793 (0.02%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tibia fracture
         subjects affected / exposed
    2 / 10793 (0.02%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haematoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Thalassaemia minor
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral arteriovenous malformation haemorrhagic
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral cavernous malformation
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral palsy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic arteriovenous malformation
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hamartoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple congenital abnormalities
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal aplasia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    13 / 10793 (0.12%)
    21 / 21587 (0.10%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    7 / 10793 (0.06%)
    27 / 21587 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 27
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute left ventricular failure
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac tamponade
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    6 / 10793 (0.06%)
    9 / 21587 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    0 / 10793 (0.00%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    4 / 10793 (0.04%)
    5 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Bundle branch block right
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brugada syndrome
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 10793 (0.03%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 10793 (0.01%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    10 / 10793 (0.09%)
    12 / 21587 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Myocardial ischaemia
         subjects affected / exposed
    2 / 10793 (0.02%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myxomatous mitral valve degeneration
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-obstructive cardiomyopathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    5 / 10793 (0.05%)
    25 / 21587 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pericarditis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    2 / 10793 (0.02%)
    4 / 21587 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic seizure
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amnesia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bulbar palsy
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery dissection
         subjects affected / exposed
    2 / 10793 (0.02%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    3 / 10793 (0.03%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery occlusion
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal dyscognitive seizures
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    3 / 10793 (0.03%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corticobasal degeneration
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed myelination
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Demyelinating polyneuropathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia homonymous
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 10793 (0.00%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal capsule infarction
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    7 / 10793 (0.06%)
    15 / 21587 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelomalacia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonic epilepsy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodegenerative disorder
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke seizure
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 10793 (0.00%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory loss
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 10793 (0.01%)
    3 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    4 / 10793 (0.04%)
    8 / 21587 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    8 / 10793 (0.07%)
    10 / 21587 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 10793 (0.00%)
    6 / 21587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercoagulation
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic cyst
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haematoma
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    3 / 10793 (0.03%)
    2 / 21587 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness bilateral
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosensory hypoacusis
         subjects affected / exposed
    1 / 10793 (0.01%)
    0 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 10793 (0.00%)
    1 / 21587 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0