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    Clinical Trial Results:
    A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial

    Summary
    EudraCT number
    		 2015-003895-65
    Trial protocol
    		 NL   BE   SE   SK   DK   FI   PT   DE   HU   ES   AT   CZ   BG   RO   PL   GB   IT  
    Global end of trial date
    23 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Sep 2022
    First version publication date
    24 Sep 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DAL-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02525939
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    DalCor Pharma UK Ltd.
    Sponsor organisation address
    Leatherhead, Swiss Branch, Zug Baarerstrasse 2, Zug, Switzerland, CH-6302
    Public contact
    Donald M. Black, DalCor Pharma, Dblack@dalcorpharma.com
    Scientific contact
    Donald M. Black, DalCor Pharma, Dblack@dalcorpharma.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
    20 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality (cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.
    Protection of trial subjects
    All considerations regarding the protection of human subjects were carried out in accordance with the protocol, GCP, ICH Guidelines, the ethical principles that have their origin in the Declaration of Helsinki, and all applicable regulatory requirements. The investigator (according to applicable regulatory requirements) or a person designated by the investigator and under the investigator’s responsibility fully informed patients of all pertinent aspects of the clinical trial.
    Background therapy
    		 Dalcetrapib and matching placebo were taken on a background of contemporary evidence-based medical care for status post-ACS, as individually prescribed by the treating physician.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Israel: 373
    Country: Number of subjects enrolled
    Russian Federation: 455
    Country: Number of subjects enrolled
    Switzerland: 36
    Country: Number of subjects enrolled
    Turkey: 57
    Country: Number of subjects enrolled
    United Arab Emirates: 16
    Country: Number of subjects enrolled
    Australia: 202
    Country: Number of subjects enrolled
    New Zealand: 150
    Country: Number of subjects enrolled
    Argentina: 148
    Country: Number of subjects enrolled
    Brazil: 431
    Country: Number of subjects enrolled
    Canada: 437
    Country: Number of subjects enrolled
    United States: 728
    Country: Number of subjects enrolled
    Chile: 94
    Country: Number of subjects enrolled
    South Africa: 222
    Country: Number of subjects enrolled
    Puerto Rico: 14
    Country: Number of subjects enrolled
    Netherlands: 276
    Country: Number of subjects enrolled
    Poland: 335
    Country: Number of subjects enrolled
    Portugal: 54
    Country: Number of subjects enrolled
    Romania: 179
    Country: Number of subjects enrolled
    Slovakia: 48
    Country: Number of subjects enrolled
    Spain: 188
    Country: Number of subjects enrolled
    Sweden: 66
    Country: Number of subjects enrolled
    United Kingdom: 382
    Country: Number of subjects enrolled
    Austria: 50
    Country: Number of subjects enrolled
    Belgium: 39
    Country: Number of subjects enrolled
    Bulgaria: 384
    Country: Number of subjects enrolled
    Czechia: 152
    Country: Number of subjects enrolled
    Denmark: 137
    Country: Number of subjects enrolled
    Finland: 20
    Country: Number of subjects enrolled
    France: 99
    Country: Number of subjects enrolled
    Germany: 69
    Country: Number of subjects enrolled
    Hungary: 183
    Country: Number of subjects enrolled
    Italy: 123
    Worldwide total number of subjects
    6147
    EEA total number of subjects
    2402
    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)
    3711
    From 65 to 84 years
    2397
    85 years and over
    39

    Subject disposition

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    Recruitment
    Recruitment details
    		 Screening procedures were performed at the time of the index ACS event or anytime thereafter, with the condition that the randomization window must have occurred within the mandated window (1 to 3 months after the index event).

    Pre-assignment
    Screening details
    		 Subjects were assessed based on their medical history. Those who were likely to qualify were consented, had a blood test obtained, and underwent a cobas® ADCY9 Genotype Clinical Trial Assay. Those patients who met the genetic testing criteria, all the other inclusion criteria, and none of the exclusion criteria were eligible for randomization.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject
    Blinding implementation details
    The blind during the study was maintained by administration of 2 matching placebo tablets to patients in the placebo group. Furthermore, the project teams of DalCor, the CROs, as well as the Investigator and his or her study personnel were blinded with respect to levels of HDL-C so as not to reveal patients’ assignment to 1 of the 2 treatment groups. Levels of triglycerides (TG) and LDL-C values were not blinded to allow for appropriate patient management.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dalcetrapib 600 mg
    Arm description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Dalcetrapib was provided as 300 mg film-coated tablets. Patients received 600 mg of dalcetrapib (2 tablets) once daily, preferably with the largest meal of the day. Dalcetrapib was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients were allowed to reduce dose to 300 mg once daily or temporarily interrupt study drug as deemed necessary due to physician assessment. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dalcetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dalcetrapib was provided as film-coated tablets of 300 mg. Patients received 600 mg of dalcetrapib (2 tablets) once daily. Study medication was taken with food, preferably with the largest meal of the day. Patients were instructed to take study medication with the same meal throughout the study. Study medication kits were dispensed at every visit. Study medication was packaged in boxes containing 7 bottles each. Each bottle contained study medication for one month, i.e., 60 pills (2 x 300 mg tablets per day). A box thus contained study medication for 7 months.

    Arm title
    		 Placebo 600 mg
    Arm description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Matching placebo was provided as 300 mg film-coated tablets. Patients received 600 mg of matching placebo (2 tablets) once daily, preferably with the largest meal of the day. The placebo was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo was provided as film-coated tablets of 300 mg. Patients received 600 mg of matching placebo (2 tablets) once daily. Study medication was taken with food, preferably with the largest meal of the day. Patients were instructed to take study medication with the same meal throughout the study. Study medication kits were dispensed at every visit. Study medication was packaged in boxes containing 7 bottles each. Each bottle contained study medication for one month, i.e., 60 pills (2 x 300 mg tablets per day). A box thus contained study medication for 7 months.

    Number of subjects in period 1
    		Dalcetrapib 600 mg Placebo 600 mg
    Started
    3071
    3076
    Completed
    2840
    2833
    Not completed
    231
    243
         Adverse event, serious fatal
    180
    179
         Consent withdrawn by subject
    24
    39
         Physician decision
    -
    1
         Lost to follow-up
    27
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dalcetrapib 600 mg
    Reporting group description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Dalcetrapib was provided as 300 mg film-coated tablets. Patients received 600 mg of dalcetrapib (2 tablets) once daily, preferably with the largest meal of the day. Dalcetrapib was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients were allowed to reduce dose to 300 mg once daily or temporarily interrupt study drug as deemed necessary due to physician assessment. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.

    Reporting group title
    Placebo 600 mg
    Reporting group description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Matching placebo was provided as 300 mg film-coated tablets. Patients received 600 mg of matching placebo (2 tablets) once daily, preferably with the largest meal of the day. The placebo was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.

    Reporting group values
    		 Dalcetrapib 600 mg Placebo 600 mg Total
    Number of subjects
    		 3071 3076 6147
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.19 ( 9.16 ) 62.34 ( 9.25 ) -
    Gender categorical
    Units: Subjects
        Female
    		 723 672 1395
        Male
    		 2348 2404 4752

    End points

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    End points reporting groups
    Reporting group title
    Dalcetrapib 600 mg
    Reporting group description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Dalcetrapib was provided as 300 mg film-coated tablets. Patients received 600 mg of dalcetrapib (2 tablets) once daily, preferably with the largest meal of the day. Dalcetrapib was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients were allowed to reduce dose to 300 mg once daily or temporarily interrupt study drug as deemed necessary due to physician assessment. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.

    Reporting group title
    Placebo 600 mg
    Reporting group description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Matching placebo was provided as 300 mg film-coated tablets. Patients received 600 mg of matching placebo (2 tablets) once daily, preferably with the largest meal of the day. The placebo was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    The primary endpoint of this study was the time from randomization to first occurrence of any component of the composite event as adjudicated by the Clinical Endpoints Committee (CEC). Components of the primary composite were cardiovascular (CV) death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke. Time to event (or censoring) was calculated as the difference (in days) between the randomization date and the date of first occurrence of an adjudicated event (or censoring date in patients without event) plus 1 day. One patient population was used for analysis of data for this study, the Intent-to-Treat (ITT) population. A stratified Cox proportional hazards model was used to analyze the primary endpoint.
    End point type
    Primary
    End point timeframe
    There was no minimum or maximum study treatment duration defined for this study, but the expected overall duration was 54 months including recruitment and follow-up.
    End point values
    		 Dalcetrapib 600 mg Placebo 600 mg
    Number of subjects analysed
    3071
    3076
    Units: patients
    3071
    3076
    Statistical analysis title
    		 Cox proportional hazards model
    Statistical analysis description
    A stratified Cox proportional hazards model was used to analyze the primary endpoint. Time to event started at randomization and subjects who were event-free were censored at the time that they were last known to be event-free. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 versus. HA: λ ≠ 1, where λ is the, assumed constant, HR for the time to occurrence of the composite events of the primary endpoint for the dalcetrapib and placebo treated groups.
    Comparison groups
    Dalcetrapib 600 mg v Placebo 600 mg
    Number of subjects included in analysis
    6147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.12
    Method
    		 Stratified Cox proportional hazards mode
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.03
    Variability estimate
    Standard deviation

    Secondary: Secondary endpoint-1

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    End point title
    		 Secondary endpoint-1
    End point description
    Time to first Occurrence of any component of the composite endpoint of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for ACS (with ECG abnormalities) or unanticipated coronary revascularization Time to event (or censoring) was calculated as the difference (in days) between the randomization date and the date of first occurrence of an adjudicated event (or censoring date in patients without event) plus 1 day. One patient population was used for analysis of data for this study, the Intent-to-Treat (ITT) population.
    End point type
    Secondary
    End point timeframe
    There was no minimum or maximum study treatment duration defined for this study, but the expected overall duration was 54 months including recruitment and follow-up.
    End point values
    		 Dalcetrapib 600 mg Placebo 600 mg
    Number of subjects analysed
    3071
    3076
    Units: patients
    3071
    3076
    Statistical analysis title
    		 Cox proportional hazards model
    Statistical analysis description
    A stratified Cox proportional hazards model was used to analyze the primary endpoint. Time to event started at randomization and subjects who were event-free were censored at the time that they were last known to be event-free. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 versus. HA: λ ≠ 1, where λ is the, assumed constant, HR for the time to occurrence of the composite events of the secondary endpoint for the dalcetrapib and placebo treated groups
    Comparison groups
    Placebo 600 mg v Dalcetrapib 600 mg
    Number of subjects included in analysis
    6147
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.945 [2]
    Method
    		 Stratified Cox proportional hazards mode
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.13
    Variability estimate
    Standard deviation
    Notes
    [1] - Cox proportional hazards model
    [2] - Results demonstrated that patients with the AA genotype at variant rs1967309 in the ADCY9 gene experienced no reduction in the risk for any component of the composite endpoint.

    Secondary: Secondary endpoint-2

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    End point title
    		 Secondary endpoint-2
    End point description
    Time to first occurrence of any component of the composite endpoint of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke or hospitalization for new or worsening heart failure. Time to event (or censoring) was calculated as the difference (in days) between the randomization date and the date of first occurrence of an adjudicated event (or censoring date in patients without event) plus 1 day. One patient population was used for analysis of data for this study, the Intent-to-Treat (ITT) population. A stratified Cox proportional hazards model was used to analyze the primary endpoint.
    End point type
    Secondary
    End point timeframe
    There was no minimum or maximum study treatment duration defined for this study, but the expected overall duration was 54 months including recruitment and follow-up.
    End point values
    		 Dalcetrapib 600 mg Placebo 600 mg
    Number of subjects analysed
    3071
    3076
    Units: patients
    3071
    3076
    Statistical analysis title
    		 Cox proportional hazards model
    Statistical analysis description
    A stratified Cox proportional hazards model was used to analyze the primary endpoint. Time to event started at randomization and subjects who were event-free were censored at the time that they were last known to be event-free. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 versus. HA: λ ≠ 1, where λ is the, assumed constant, HR for the time to occurrence of the composite events of the secondary endpoint for the dalcetrapib and placebo treated groups.
    Comparison groups
    Dalcetrapib 600 mg v Placebo 600 mg
    Number of subjects included in analysis
    6147
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.27 [3]
    Method
    		 Stratified Cox proportional hazards mode
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.07
    Variability estimate
    Standard deviation
    Notes
    [3] - Treatment with dalcetrapib failed to meet the pre-specified threshold for a positive outcome in regards to the secondary endpoint-2.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event monitoring starts from the time the patient consents to the study until they complete the trial
    Adverse event reporting additional description
    A Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred on or after the administration of the first dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo 600 mg
    Reporting group description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Matching placebo was provided as 300 mg film-coated tablets. Patients received 600 mg of matching placebo (2 tablets) once daily, preferably with the largest meal of the day. The placebo was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.

    Reporting group title
    Dalcetrapib 600 mg
    Reporting group description
    		 Patients recently hospitalized for an ACS (between 1 month and 3 months after the index event). Dalcetrapib was provided as 300 mg film-coated tablets. Patients received 600 mg of dalcetrapib (2 tablets) once daily, preferably with the largest meal of the day. Dalcetrapib was taken on a background of contemporary evidence-based medical care for ACS, including aspirin, clopidogrel, beta-blockers, angiotensin-converting enzyme inhibitors, and statins; and medication for optimal control of hypertension, angina, and diabetes. Patients were allowed to reduce dose to 300 mg once daily or temporarily interrupt study drug as deemed necessary due to physician assessment. Patients visited the clinic 1 month and 6 months after randomization and every 6 months thereafter. The study lasted until approximately 582 patients experienced a primary event, at which time the sites were contacted and asked to bring their patients in for final visits.

    Serious adverse events
    		 Placebo 600 mg Dalcetrapib 600 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    923 / 3076 (30.01%)
    900 / 3071 (29.31%)
         number of deaths (all causes)
    179
    180
         number of deaths resulting from adverse events
    133
    127
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute leukaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Adenocarcinoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical fibroxanthoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of prostate
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    9 / 3076 (0.29%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    3 / 3076 (0.10%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chest wall tumour
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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 stage 1
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    8 / 3076 (0.26%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Colon cancer metastatic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer stage IV
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial sarcoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epstein-Barr virus associated lymphoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Giant cell tumour of tendon sheath
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Glioma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic cancer recurrent
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Laryngeal papilloma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    5 / 3076 (0.16%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Lymphoma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant polyp
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to adrenals
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to liver
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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 metastatic
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian epithelial cancer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma recurrent
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    27 / 3076 (0.88%)
    10 / 3071 (0.33%)
         occurrences causally related to treatment / all
    1 / 28
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage I
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tumour haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic intramural haematoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    9 / 3076 (0.29%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial insufficiency
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arterial occlusive disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial perforation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arteritis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    10 / 3076 (0.33%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    5 / 3076 (0.16%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (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
    7 / 3076 (0.23%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphocele
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    5 / 3076 (0.16%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboangiitis obliterans
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Aneurysm repair
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrodesis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atherectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure management
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone lesion excision
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac rehabilitation therapy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithotomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy closure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary angioplasty
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery bypass
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary revascularisation
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Finger amputation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart transplant
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia repair
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    11 / 3076 (0.36%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insertion of ambulatory peritoneal catheter
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoplasty
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left atrial appendage occlusion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb amputation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lithotripsy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device change
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic fluid drainage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ossiculoplasty
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rehabilitation therapy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue flap operation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stem cell transplant
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth extraction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour excision
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral dilation procedure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitrectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chest discomfort
         subjects affected / exposed
    7 / 3076 (0.23%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    79 / 3076 (2.57%)
    81 / 3071 (2.64%)
         occurrences causally related to treatment / all
    0 / 93
    0 / 104
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    8 / 3076 (0.26%)
    17 / 3071 (0.55%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 17
         deaths causally related to treatment / all
    0 / 8
    0 / 17
    Drowning
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Generalised oedema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired self-care
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    28 / 3076 (0.91%)
    41 / 3071 (1.34%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacemaker generated arrhythmia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    3 / 3076 (0.10%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 8
    Sudden death
         subjects affected / exposed
    14 / 3076 (0.46%)
    16 / 3071 (0.52%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 16
         deaths causally related to treatment / all
    0 / 14
    1 / 16
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent restenosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Alcohol use
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sight disability
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 3076 (0.16%)
    9 / 3071 (0.29%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    8 / 3076 (0.26%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 8
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Aspiration
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bullous lung disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    19 / 3076 (0.62%)
    15 / 3071 (0.49%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    8 / 3076 (0.26%)
    16 / 3071 (0.52%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    3 / 3076 (0.10%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal granuloma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiogenic pulmonary oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pulmonary mass
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    4 / 3076 (0.13%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Depression
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucinations, mixed
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizoaffective disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatic symptom disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device material issue
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    4 / 3076 (0.13%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    8 / 3076 (0.26%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiogram
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram coronary
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy prostate
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood folate decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac murmur
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid bruit
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoscopy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diagnostic procedure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult blood positive
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep study
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcus test positive
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress echocardiogram abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteroscopy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic complication
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis traumatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costal cartilage fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Electric shock
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye burns
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    6 / 3076 (0.20%)
    11 / 3071 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Femoral neck fracture
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    6 / 3076 (0.20%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria traumatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incomplete spinal fusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (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 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirenal haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural discomfort
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative respiratory failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural nausea
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tendon rupture
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    Atrial septal defect
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicuspid aortic valve
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adams-Stokes syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    50 / 3076 (1.63%)
    52 / 3071 (1.69%)
         occurrences causally related to treatment / all
    0 / 55
    0 / 53
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angina unstable
         subjects affected / exposed
    23 / 3076 (0.75%)
    19 / 3071 (0.62%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    36 / 3076 (1.17%)
    31 / 3071 (1.01%)
         occurrences causally related to treatment / all
    1 / 47
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    6 / 3076 (0.20%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    6 / 3076 (0.20%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    5 / 3076 (0.16%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Cardiac failure
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Cardiac failure acute
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Cardiogenic shock
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carditis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    23 / 3076 (0.75%)
    30 / 3071 (0.98%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery dissection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    7 / 3076 (0.23%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Long QT syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    12 / 3076 (0.39%)
    12 / 3071 (0.39%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Myocarditis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systolic dysfunction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burning sensation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidotic hyperglycaemic coma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disturbance in attention
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    8 / 3076 (0.26%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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 / 3076 (0.00%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    28 / 3076 (0.91%)
    24 / 3071 (0.78%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    10 / 3076 (0.33%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         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
    21 / 3076 (0.68%)
    19 / 3071 (0.62%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma recurrent
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic vein thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear canal stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (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
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blindness transient
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic nerve disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy of prematurity
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    6 / 3076 (0.20%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Auriculotemporal syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac artery stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    8 / 3076 (0.26%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival recession
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory bowel disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    5 / 3076 (0.16%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric panniculitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal dysplasia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    14 / 3076 (0.46%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    1 / 16
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal venous gas
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ecchymosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin mass
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Xanthelasma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    20 / 3076 (0.65%)
    18 / 3071 (0.59%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anuria
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder dysplasia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    9 / 3076 (0.29%)
    13 / 3071 (0.42%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Micturition disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    4 / 3076 (0.13%)
    9 / 3071 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cushing's syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic goitre
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    9 / 3076 (0.29%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 3076 (0.07%)
    6 / 3071 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee impingement syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb deformity
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle twitching
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    9 / 3076 (0.29%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    27 / 3076 (0.88%)
    23 / 3071 (0.75%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in jaw
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral osteophyte
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess of salivary gland
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    8 / 3076 (0.26%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerotic gangrene
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve vegetation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    12 / 3076 (0.39%)
    12 / 3071 (0.39%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    43 / 3076 (1.40%)
    45 / 3071 (1.47%)
         occurrences causally related to treatment / all
    0 / 44
    0 / 45
         deaths causally related to treatment / all
    0 / 15
    0 / 11
    Creutzfeldt-Jakob disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cystitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Device related infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diarrhoea infectious
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    6 / 3076 (0.20%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer helicobacter
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis bacterial
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus bacteraemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    8 / 3076 (0.26%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes simplex
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreas infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    41 / 3076 (1.33%)
    39 / 3071 (1.27%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 45
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Pneumonia bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia escherichia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    19 / 3076 (0.62%)
    14 / 3071 (0.46%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 16
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Septic shock
         subjects affected / exposed
    8 / 3076 (0.26%)
    10 / 3071 (0.33%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Serratia bacteraemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinusitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    7 / 3076 (0.23%)
    17 / 3071 (0.55%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    8 / 3076 (0.26%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Adult failure to thrive
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes with hyperosmolarity
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar hyperglycaemic state
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    5 / 3076 (0.16%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Obesity
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 600 mg Dalcetrapib 600 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2363 / 3076 (76.82%)
    2380 / 3071 (77.50%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acanthoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Acrochordon
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Adenoma benign
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Adrenal adenoma
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Anogenital warts
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Atypical fibroxanthoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
         subjects affected / exposed
    15 / 3076 (0.49%)
    26 / 3071 (0.85%)
         occurrences all number
    22
    27
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Benign breast neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Benign lymph node neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Benign neoplasm of skin
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bladder cancer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bowen's disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Breast adenoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Breast cancer metastatic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Breast cancer recurrent
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Breast neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bronchial neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Carcinoid tumour
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Colon adenoma
         subjects affected / exposed
    7 / 3076 (0.23%)
    8 / 3071 (0.26%)
         occurrences all number
    9
    8
    Colon neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Colon cancer
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Dysplastic naevus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Enchondromatosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fibrous histiocytoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Haemangioma of liver
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Haemangioma
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Haemangioma of skin
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hodgkin's disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Keratoacanthoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Kidney angiomyolipoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Laryngeal cancer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Leiomyoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Lentigo maligna
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Lipoma
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Malignant melanoma
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences all number
    3
    8
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Melanocytic naevus
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences all number
    0
    4
    Metastases to bone
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Metastases to lung
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Metastases to thorax
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Monoclonal gammopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Neoplasm malignant
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Neoplasm skin
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Neuroma
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ocular neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Oral papilloma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Papilloma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Plasma cell myeloma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pleural mesothelioma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Polycythaemia vera
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostate cancer
         subjects affected / exposed
    8 / 3076 (0.26%)
    5 / 3071 (0.16%)
         occurrences all number
    8
    5
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostatic adenoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Pyogenic granuloma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rectal cancer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rectal neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Renal cell carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Renal neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Salivary gland neoplasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Seborrhoeic keratosis
         subjects affected / exposed
    7 / 3076 (0.23%)
    6 / 3071 (0.20%)
         occurrences all number
    7
    6
    Skin cancer
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences all number
    5
    2
    Skin papilloma
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Small cell lung cancer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Squamous cell carcinoma
         subjects affected / exposed
    9 / 3076 (0.29%)
    5 / 3071 (0.16%)
         occurrences all number
    10
    5
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tonsil cancer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Uterine leiomyoma
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Vulval cancer stage 0
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vulval cancer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Angiopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Angiosclerosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Aortic aneurysm
         subjects affected / exposed
    8 / 3076 (0.26%)
    9 / 3071 (0.29%)
         occurrences all number
    8
    9
    Aortic calcification
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Aortic arteriosclerosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Aortic dilatation
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    4
    Aortic dissection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Aortic stenosis
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Aortic thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Arterial disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Arteriosclerosis
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    6
    Arteriosclerosis Moenckeberg-type
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arteritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Axillary vein thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Behcet's syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blood pressure fluctuation
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    6
    Blood pressure inadequately controlled
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Brachiocephalic arteriosclerosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Brachiocephalic vein stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Capillary fragility
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Circulatory collapse
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Contusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Diastolic hypertension
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Dizziness
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Dry gangrene
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Embolism
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Embolism venous
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Embolism arterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Flushing
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Haematoma
         subjects affected / exposed
    17 / 3076 (0.55%)
    17 / 3071 (0.55%)
         occurrences all number
    19
    18
    Haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Hot flush
         subjects affected / exposed
    9 / 3076 (0.29%)
    6 / 3071 (0.20%)
         occurrences all number
    9
    6
    Hypertension
         subjects affected / exposed
    266 / 3076 (8.65%)
    277 / 3071 (9.02%)
         occurrences all number
    312
    322
    Hypertensive angiopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hypertensive crisis
         subjects affected / exposed
    18 / 3076 (0.59%)
    24 / 3071 (0.78%)
         occurrences all number
    25
    25
    Hypotension
         subjects affected / exposed
    73 / 3076 (2.37%)
    78 / 3071 (2.54%)
         occurrences all number
    75
    82
    Intermittent claudication
         subjects affected / exposed
    6 / 3076 (0.20%)
    15 / 3071 (0.49%)
         occurrences all number
    6
    15
    Ischaemia
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Labile blood pressure
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Labile hypertension
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Lymphoedema
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Non-dipping
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Orthostatic hypertension
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Orthostatic hypotension
         subjects affected / exposed
    21 / 3076 (0.68%)
    14 / 3071 (0.46%)
         occurrences all number
    21
    14
    Perineal haematoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Peripheral arterial occlusive disease
         subjects affected / exposed
    7 / 3076 (0.23%)
    8 / 3071 (0.26%)
         occurrences all number
    7
    8
    Peripheral artery aneurysm
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Peripheral artery stenosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Peripheral coldness
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Peripheral ischaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Peripheral venous disease
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    6
    Peripheral vascular disorder
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences all number
    2
    5
    Phlebitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Poor peripheral circulation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    5 / 3076 (0.16%)
    6 / 3071 (0.20%)
         occurrences all number
    5
    6
    Shock
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Subclavian steal syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Temporal arteritis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Thrombophlebitis superficial
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Thrombosed varicose vein
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Varicose ulceration
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Varicose vein
         subjects affected / exposed
    6 / 3076 (0.20%)
    8 / 3071 (0.26%)
         occurrences all number
    6
    8
    Vasculitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vasospasm
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vasodilatation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Surgical and medical procedures
    Abdominal cavity drainage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Abdominal hernia repair
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Abscess drainage
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Acrochordon excision
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Angioplasty
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Aortic surgery
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Aortic valve replacement
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Appendicectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Arterial stent insertion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arthrodesis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Arthrotomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blepharoplasty
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Breast prosthesis implantation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bunion operation
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Cardiac ablation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cardiac pacemaker battery replacement
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiac pacemaker replacement
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cardiac pacemaker insertion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiac rehabilitation therapy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Cardioversion
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Carotid endarterectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Carpal tunnel decompression
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Cataract operation
         subjects affected / exposed
    12 / 3076 (0.39%)
    24 / 3071 (0.78%)
         occurrences all number
    16
    31
    Chemotherapy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cholecystectomy
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Circumcision
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Corneal transplant
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Coronary angioplasty
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Coronary artery bypass
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Coronary revascularisation
         subjects affected / exposed
    5 / 3076 (0.16%)
    9 / 3071 (0.29%)
         occurrences all number
    6
    9
    Cyst removal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dental implantation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Dental operation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dermatofibroma removal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Drain placement
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Elective surgery
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Endodontic procedure
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Endovenous ablation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Foot operation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal endoscopic therapy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Glaucoma surgery
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hernia repair
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Hip arthroplasty
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Hip surgery
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hospitalisation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Implantable cardiac monitor insertion
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Implantable defibrillator insertion
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Incisional drainage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia repair
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Intestinal polypectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Joint debridement
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Knee arthroplasty
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Knee operation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Large intestinal polypectomy
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    5
    Left atrial appendage occlusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Leg amputation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Lens extraction
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    2
    Lithotripsy
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Mass excision
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Meniscus removal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Mole excision
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Osteosynthesis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Osteotomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Percutaneous coronary intervention
         subjects affected / exposed
    4 / 3076 (0.13%)
    5 / 3071 (0.16%)
         occurrences all number
    4
    5
    Peripheral nerve decompression
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Peripheral nerve transposition
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Polypectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    4
    Post procedural drainage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Postoperative care
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostatic operation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pterygium operation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pulmonary resection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rectal polypectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Removal of internal fixation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Retinal laser coagulation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rotator cuff repair
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Skin graft
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Skin lesion excision
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Skin neoplasm excision
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    2
    Small intestinal anastomosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Spinal fusion surgery
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Spinal laminectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Splenectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Stent placement
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Suprapubic prostatectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Suture insertion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tendon sheath incision
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Thyroidectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Toe amputation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    11 / 3076 (0.36%)
    14 / 3071 (0.46%)
         occurrences all number
    12
    14
    Tooth repair
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Trabeculectomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tracheostomy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Transurethral prostatectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Umbilical hernia repair
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Ureteral stent insertion
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Urethral dilation procedure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Urethrotomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Uterine prolapse repair
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Varicose vein operation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    4
    Vitrectomy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Administration site extravasation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Adverse drug reaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    5
    Adverse reaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Application site pruritus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    32 / 3076 (1.04%)
    45 / 3071 (1.47%)
         occurrences all number
    33
    47
    Catheter site haematoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Catheter site pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Catheter site phlebitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
         subjects affected / exposed
    38 / 3076 (1.24%)
    49 / 3071 (1.60%)
         occurrences all number
    41
    53
    Chest pain
         subjects affected / exposed
    239 / 3076 (7.77%)
    268 / 3071 (8.73%)
         occurrences all number
    295
    334
    Chills
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Crepitations
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cyst
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    4
    Discomfort
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Drug intolerance
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Dysplasia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Early satiety
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Exercise tolerance decreased
         subjects affected / exposed
    6 / 3076 (0.20%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    4
    Face oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Facial pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fat necrosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    101 / 3076 (3.28%)
    115 / 3071 (3.74%)
         occurrences all number
    104
    123
    Feeling cold
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Feeling abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Feeling drunk
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Feeling hot
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Feeling jittery
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Feeling of body temperature change
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    General physical health deterioration
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    General symptom
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Generalised oedema
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Haemorrhagic cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hernia
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Hernia pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hunger
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Hypothermia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Impaired healing
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Implant site haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Implant site pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Implant site swelling
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Induration
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Inflammation
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Influenza like illness
         subjects affected / exposed
    17 / 3076 (0.55%)
    13 / 3071 (0.42%)
         occurrences all number
    21
    16
    Injection site erythema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Injection site haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Local swelling
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    12 / 3076 (0.39%)
    7 / 3071 (0.23%)
         occurrences all number
    12
    7
    Mass
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Medical device site pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Mucosal inflammation
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Nodule
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    75 / 3076 (2.44%)
    66 / 3071 (2.15%)
         occurrences all number
    96
    82
    Oedema
         subjects affected / exposed
    6 / 3076 (0.20%)
    10 / 3071 (0.33%)
         occurrences all number
    6
    10
    Oedema peripheral
         subjects affected / exposed
    60 / 3076 (1.95%)
    62 / 3071 (2.02%)
         occurrences all number
    62
    65
    Pain
         subjects affected / exposed
    25 / 3076 (0.81%)
    19 / 3071 (0.62%)
         occurrences all number
    26
    20
    Peripheral swelling
         subjects affected / exposed
    20 / 3076 (0.65%)
    21 / 3071 (0.68%)
         occurrences all number
    21
    21
    Polyp
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Postoperative fever
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    24 / 3076 (0.78%)
    21 / 3071 (0.68%)
         occurrences all number
    24
    22
    Sensation of foreign body
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Swelling
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Temperature intolerance
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Ulcer
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vaccination site reaction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Vascular stent restenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Immune system disorders
    Allergic oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Amyloidosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Contrast media allergy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    8 / 3076 (0.26%)
    4 / 3071 (0.13%)
         occurrences all number
    8
    4
    Food allergy
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Hypersensitivity
         subjects affected / exposed
    11 / 3076 (0.36%)
    7 / 3071 (0.23%)
         occurrences all number
    13
    8
    Immunisation reaction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sarcoidosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    9
    1
    Seasonal allergy
         subjects affected / exposed
    8 / 3076 (0.26%)
    8 / 3071 (0.26%)
         occurrences all number
    8
    8
    Social circumstances
    Menopause
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Poor personal hygiene
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Stress at work
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tobacco user
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Treatment noncompliance
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Vascular device user
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Benign prostatic hyperplasia
         subjects affected / exposed
    36 / 3076 (1.17%)
    36 / 3071 (1.17%)
         occurrences all number
    37
    36
    Breast calcifications
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Breast cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Breast mass
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    4
    Breast pain
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Breast tenderness
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Breast ulceration
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cervical cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cervical dysplasia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cervix disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cystocele
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ejaculation failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Endometrial thickening
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Epididymal cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    35 / 3076 (1.14%)
    34 / 3071 (1.11%)
         occurrences all number
    35
    34
    Fibrocystic breast disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Genital atrophy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Genital discomfort
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Genital hypoaesthesia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Genital prolapse
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Genital rash
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Gynaecomastia
         subjects affected / exposed
    3 / 3076 (0.10%)
    6 / 3071 (0.20%)
         occurrences all number
    3
    6
    Haematospermia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Hydrocele female
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Menorrhagia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Metrorrhagia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Ovarian cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Pelvic pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Penile pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Peyronie's disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostatic obstruction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostatism
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    5
    Prostatitis
         subjects affected / exposed
    8 / 3076 (0.26%)
    9 / 3071 (0.29%)
         occurrences all number
    8
    10
    Prostatomegaly
         subjects affected / exposed
    6 / 3076 (0.20%)
    7 / 3071 (0.23%)
         occurrences all number
    6
    7
    Pruritus genital
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Rectocele
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Retrograde ejaculation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Scrotal swelling
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Sexual dysfunction
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Testicular atrophy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Testicular mass
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Testicular pain
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Uterine polyp
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Vaginal prolapse
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Varicocele
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Vulvovaginal discomfort
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Acute respiratory failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Aphonia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Apnoea
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Aspiration
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Asthma
         subjects affected / exposed
    12 / 3076 (0.39%)
    12 / 3071 (0.39%)
         occurrences all number
    13
    15
    Asthmatic crisis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Atelectasis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Bendopnoea
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bronchial obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bronchiectasis
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    5
    2
    Bronchitis chronic
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    6
    Bronchospasm
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Catarrh
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Chronic respiratory failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    48 / 3076 (1.56%)
    29 / 3071 (0.94%)
         occurrences all number
    57
    47
    Cough
         subjects affected / exposed
    95 / 3076 (3.09%)
    140 / 3071 (4.56%)
         occurrences all number
    101
    159
    Dry throat
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dysphonia
         subjects affected / exposed
    12 / 3076 (0.39%)
    3 / 3071 (0.10%)
         occurrences all number
    12
    3
    Dyspnoea
         subjects affected / exposed
    155 / 3076 (5.04%)
    152 / 3071 (4.95%)
         occurrences all number
    168
    171
    Dyspnoea at rest
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Dyspnoea exertional
         subjects affected / exposed
    59 / 3076 (1.92%)
    40 / 3071 (1.30%)
         occurrences all number
    59
    41
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Emphysema
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    7
    Eosinophilic bronchitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    46 / 3076 (1.50%)
    55 / 3071 (1.79%)
         occurrences all number
    58
    67
    Haemoptysis
         subjects affected / exposed
    4 / 3076 (0.13%)
    11 / 3071 (0.36%)
         occurrences all number
    4
    11
    Hiccups
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Hydrothorax
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Hyperventilation
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Hypoxia
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Increased bronchial secretion
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Increased upper airway secretion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Laryngeal oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Laryngeal ulceration
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Laryngospasm
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Lung cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Lung infiltration
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Nasal discomfort
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Nasal congestion
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    7
    9
    Nasal dryness
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Nasal obstruction
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Nasal polyps
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Nasal turbinate abnormality
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nocturnal dyspnoea
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    6 / 3076 (0.20%)
    20 / 3071 (0.65%)
         occurrences all number
    6
    22
    Painful respiration
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pharyngeal paraesthesia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Pharyngeal lesion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pleural adhesion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pleural effusion
         subjects affected / exposed
    11 / 3076 (0.36%)
    6 / 3071 (0.20%)
         occurrences all number
    12
    6
    Pleuritic pain
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Pneumonia aspiration
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Pneumothorax
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Productive cough
         subjects affected / exposed
    7 / 3076 (0.23%)
    6 / 3071 (0.20%)
         occurrences all number
    8
    6
    Pulmonary embolism
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Pulmonary fibrosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Pulmonary infarction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pulmonary mass
         subjects affected / exposed
    10 / 3076 (0.33%)
    17 / 3071 (0.55%)
         occurrences all number
    10
    19
    Pulmonary oedema
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Pulmonary pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Reflux laryngitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Respiration abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Respiratory acidosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Respiratory disorder
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences all number
    6
    3
    Respiratory distress
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Respiratory muscle weakness
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Respiratory failure
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Respiratory symptom
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Respiratory tract congestion
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    5
    Respiratory tract inflammation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    15 / 3076 (0.49%)
    10 / 3071 (0.33%)
         occurrences all number
    15
    11
    Rhinitis allergic
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Rhonchi
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Sinus disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Sinus polyp
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    33 / 3076 (1.07%)
    28 / 3071 (0.91%)
         occurrences all number
    33
    28
    Sneezing
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sputum increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Wheezing
         subjects affected / exposed
    6 / 3076 (0.20%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    6
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Abnormal dreams
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Adjustment disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Adjustment disorder with mixed anxiety and depressed mood
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Affect lability
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Affective disorder
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Aggression
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Agitation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    2
    Alcohol abuse
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Alcohol withdrawal syndrome
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Alcoholism
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Anger
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    50 / 3076 (1.63%)
    56 / 3071 (1.82%)
         occurrences all number
    53
    58
    Anxiety disorder
         subjects affected / exposed
    2 / 3076 (0.07%)
    6 / 3071 (0.20%)
         occurrences all number
    2
    6
    Apathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Binge drinking
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bruxism
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Burnout syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Claustrophobia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Confusional state
         subjects affected / exposed
    4 / 3076 (0.13%)
    5 / 3071 (0.16%)
         occurrences all number
    4
    7
    Delirium
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    5
    6
    Depressed mood
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Depression
         subjects affected / exposed
    56 / 3076 (1.82%)
    55 / 3071 (1.79%)
         occurrences all number
    60
    56
    Disorientation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Drug dependence
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Eating disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Emotional disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hallucination
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Impulsive behaviour
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Initial insomnia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    36 / 3076 (1.17%)
    53 / 3071 (1.73%)
         occurrences all number
    40
    55
    Irritability
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Libido decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Loss of libido
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Major depression
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Mental fatigue
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Mental status changes
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Mood altered
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Mood swings
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Nightmare
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    3
    Obsessive-compulsive disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Panic attack
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Panic disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Panic reaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Persecutory delusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Polydipsia psychogenic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Rapid eye movement sleep behaviour disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Restlessness
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Sleep disorder
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    6
    Somnolence
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Stress
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    7
    Suicidal ideation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Product issues
    Device breakage
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Device dislocation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Device failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Device issue
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Device malfunction
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Device material opacification
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Device stimulation issue
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Product difficult to swallow
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bile duct obstruction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bile duct stone
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Biliary colic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Biliary cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Biliary dyskinesia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Biloma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cholangitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cholecystitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Cholelithiasis
         subjects affected / exposed
    22 / 3076 (0.72%)
    12 / 3071 (0.39%)
         occurrences all number
    22
    12
    Cholecystitis chronic
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Cholecystitis acute
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cholestasis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gallbladder enlargement
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Gallbladder polyp
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Hepatic cyst
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Hepatic failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hepatic function abnormal
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Hepatic lesion
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Hepatic mass
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    12 / 3076 (0.39%)
    9 / 3071 (0.29%)
         occurrences all number
    12
    9
    Hepatic pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hepatocellular injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Hepatomegaly
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Liver disorder
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Non-alcoholic fatty liver
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 3076 (0.20%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    4
    Angiogram
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Anticoagulation drug level below therapeutic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Antinuclear antibody
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Antinuclear antibody positive
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arteriogram coronary
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    5
    Arthroscopy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Aspiration pleural cavity
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Biopsy liver
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Biopsy prostate
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Biopsy skin normal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Biopsy stomach abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bleeding time prolonged
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Blood bilirubin increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Blood calcium decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blood calcium increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Blood creatine increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    14 / 3076 (0.46%)
    10 / 3071 (0.33%)
         occurrences all number
    15
    10
    Blood creatinine increased
         subjects affected / exposed
    12 / 3076 (0.39%)
    15 / 3071 (0.49%)
         occurrences all number
    13
    15
    Blood folate decreased
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Blood glucose abnormal
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    6 / 3076 (0.20%)
    18 / 3071 (0.59%)
         occurrences all number
    6
    18
    Blood iron decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Blood lactic acid increased
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    7
    Blood potassium decreased
         subjects affected / exposed
    7 / 3076 (0.23%)
    6 / 3071 (0.20%)
         occurrences all number
    7
    6
    Blood potassium increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Blood pressure abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Blood pressure decreased
         subjects affected / exposed
    38 / 3076 (1.24%)
    36 / 3071 (1.17%)
         occurrences all number
    43
    38
    Blood pressure diastolic decreased
         subjects affected / exposed
    36 / 3076 (1.17%)
    36 / 3071 (1.17%)
         occurrences all number
    40
    41
    Blood pressure diastolic increased
         subjects affected / exposed
    48 / 3076 (1.56%)
    31 / 3071 (1.01%)
         occurrences all number
    50
    32
    Blood pressure difference of extremities
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    71 / 3076 (2.31%)
    59 / 3071 (1.92%)
         occurrences all number
    79
    70
    Blood pressure orthostatic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blood pressure systolic decreased
         subjects affected / exposed
    61 / 3076 (1.98%)
    51 / 3071 (1.66%)
         occurrences all number
    65
    55
    Blood pressure systolic increased
         subjects affected / exposed
    64 / 3076 (2.08%)
    54 / 3071 (1.76%)
         occurrences all number
    65
    58
    Blood test abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blood testosterone decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Blood thyroid stimulating hormone abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Blood triglycerides
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    20 / 3076 (0.65%)
    12 / 3071 (0.39%)
         occurrences all number
    22
    12
    Blood urea increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Blood uric acid increased
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Blood urine present
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Body temperature increased
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Brain natriuretic peptide increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Breath sounds
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Breath sounds abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    C-reactive protein abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    18 / 3076 (0.59%)
    15 / 3071 (0.49%)
         occurrences all number
    18
    15
    Cardiac imaging procedure abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Cardiac murmur
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Cardiac stress test abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Carotid bruit
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Catheterisation cardiac
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Colonoscopy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Cystoscopy
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    8
    2
    Echocardiogram abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ejection fraction decreased
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Electrocardiogram P wave abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram PR prolongation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    5 / 3076 (0.16%)
    0 / 3071 (0.00%)
         occurrences all number
    5
    0
    Electrocardiogram T wave amplitude decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Electrocardiogram change
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Faecal calprotectin increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fibrin D dimer increased
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences all number
    2
    5
    Fractional flow reserve
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Free prostate-specific antigen increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Functional residual capacity decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    General physical condition abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Glomerular filtration rate abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    4
    Glucose tolerance increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    21 / 3076 (0.68%)
    18 / 3071 (0.59%)
         occurrences all number
    22
    18
    Grip strength decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    HIV test positive
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    6 / 3076 (0.20%)
    12 / 3071 (0.39%)
         occurrences all number
    6
    14
    Heart rate abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Heart rate decreased
         subjects affected / exposed
    5 / 3076 (0.16%)
    17 / 3071 (0.55%)
         occurrences all number
    5
    17
    Heart rate increased
         subjects affected / exposed
    7 / 3076 (0.23%)
    11 / 3071 (0.36%)
         occurrences all number
    7
    15
    Heart rate irregular
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Helicobacter test positive
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    9 / 3076 (0.29%)
    8 / 3071 (0.26%)
         occurrences all number
    10
    9
    High density lipoprotein decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    International normalised ratio
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Laboratory test abnormal
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Lipids increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Liver function test abnormal
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    5
    7
    Liver function test increased
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    5
    Low density lipoprotein decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Low density lipoprotein increased
         subjects affected / exposed
    5 / 3076 (0.16%)
    7 / 3071 (0.23%)
         occurrences all number
    5
    8
    Mammogram abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Norovirus test positive
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Occult blood
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Occult blood positive
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Oesophagogastroduodenoscopy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Optic nerve cup/disc ratio increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Oxygen saturation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pedal pulse decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Platelet count decreased
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    2
    Positron emission tomogram abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Precancerous cells present
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Prostatic specific antigen increased
         subjects affected / exposed
    8 / 3076 (0.26%)
    9 / 3071 (0.29%)
         occurrences all number
    9
    9
    Pulse absent
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    QRS axis abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Radial pulse abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Radioisotope scan
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Serum ferritin decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Serum ferritin increased
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Single photon emission computerised tomogram abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Streptococcus test positive
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Stress echocardiogram abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Thyroid function test abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Treponema test
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Troponin T increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Troponin increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Ultrasound Doppler abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ultrasound prostate abnormal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ureteroscopy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Urine output decreased
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Vital functions abnormal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vitamin B12 decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Vitamin D decreased
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Weight decreased
         subjects affected / exposed
    23 / 3076 (0.75%)
    27 / 3071 (0.88%)
         occurrences all number
    25
    27
    Weight increased
         subjects affected / exposed
    19 / 3076 (0.62%)
    25 / 3071 (0.81%)
         occurrences all number
    19
    25
    White blood cell count increased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Alcohol poisoning
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Anaemia postoperative
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Anastomotic ulcer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Animal bite
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Ankle fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    6 / 3071 (0.20%)
         occurrences all number
    2
    6
    Arthropod sting
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Arthropod bite
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences all number
    3
    8
    Back injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences all number
    2
    6
    Bone contusion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cartilage injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Chemical burns of eye
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Chest injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Chillblains
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Clavicle fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Concussion
         subjects affected / exposed
    3 / 3076 (0.10%)
    6 / 3071 (0.20%)
         occurrences all number
    3
    6
    Contusion
         subjects affected / exposed
    37 / 3076 (1.20%)
    50 / 3071 (1.63%)
         occurrences all number
    41
    54
    Corneal abrasion
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Costal cartilage fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Craniocerebral injury
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Cystitis radiation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dislocation of vertebra
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Electric shock
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Epicondylitis
         subjects affected / exposed
    6 / 3076 (0.20%)
    8 / 3071 (0.26%)
         occurrences all number
    6
    9
    Eschar
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Excoriation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Exposure to toxic agent
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eye contusion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eye injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Eyelid injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Face injury
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Facial bones fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Fall
         subjects affected / exposed
    40 / 3076 (1.30%)
    40 / 3071 (1.30%)
         occurrences all number
    44
    44
    Fibula fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Foot fracture
         subjects affected / exposed
    12 / 3076 (0.39%)
    7 / 3071 (0.23%)
         occurrences all number
    13
    7
    Forearm fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Foreign body
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Foreign body in eye
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Fracture displacement
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    2
    Gun shot wound
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hand fracture
         subjects affected / exposed
    6 / 3076 (0.20%)
    11 / 3071 (0.36%)
         occurrences all number
    6
    11
    Head injury
         subjects affected / exposed
    8 / 3076 (0.26%)
    4 / 3071 (0.13%)
         occurrences all number
    8
    4
    Hip fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Humerus fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Immunisation reaction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Incision site haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Incisional hernia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Injury
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Injury corneal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation
         subjects affected / exposed
    4 / 3076 (0.13%)
    5 / 3071 (0.16%)
         occurrences all number
    4
    5
    Joint injury
         subjects affected / exposed
    7 / 3076 (0.23%)
    9 / 3071 (0.29%)
         occurrences all number
    7
    9
    Laceration
         subjects affected / exposed
    21 / 3076 (0.68%)
    23 / 3071 (0.75%)
         occurrences all number
    21
    23
    Ligament injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ligament rupture
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Ligament sprain
         subjects affected / exposed
    20 / 3076 (0.65%)
    27 / 3071 (0.88%)
         occurrences all number
    20
    28
    Limb crushing injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Limb injury
         subjects affected / exposed
    17 / 3076 (0.55%)
    21 / 3071 (0.68%)
         occurrences all number
    18
    21
    Limb traumatic amputation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Lower limb fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Medication error
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Meniscus injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences all number
    2
    7
    Mouth injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Multiple fractures
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Muscle injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Muscle rupture
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Muscle strain
         subjects affected / exposed
    19 / 3076 (0.62%)
    14 / 3071 (0.46%)
         occurrences all number
    21
    14
    Musculoskeletal injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Nasal injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Nerve injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Oesophageal injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Overdose
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Patella fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Pelvic fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Peripheral artery restenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Peroneal nerve injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Post concussion syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Post procedural constipation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Post procedural fistula
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Post-traumatic pain
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Post-traumatic neck syndrome
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Postoperative ileus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Postoperative thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Postoperative wound complication
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Procedural dizziness
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Procedural haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Procedural hypotension
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Procedural pain
         subjects affected / exposed
    9 / 3076 (0.29%)
    1 / 3071 (0.03%)
         occurrences all number
    9
    1
    Procedural vomiting
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Radiation pneumonitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Radius fracture
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences all number
    6
    3
    Rib fracture
         subjects affected / exposed
    8 / 3076 (0.26%)
    12 / 3071 (0.39%)
         occurrences all number
    8
    12
    Road traffic accident
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences all number
    2
    7
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Scratch
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Skin abrasion
         subjects affected / exposed
    0 / 3076 (0.00%)
    6 / 3071 (0.20%)
         occurrences all number
    0
    7
    Skull fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Soft tissue injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    6 / 3071 (0.20%)
         occurrences all number
    1
    6
    Spinal column injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Spinal compression fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Spinal fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Sternal fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Stress fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Subcutaneous haematoma
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Subdural haematoma
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Subdural haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Synovial rupture
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tendon injury
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Tendon rupture
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    9
    9
    Thermal burn
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tibia fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Tooth injury
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Traumatic arthritis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Traumatic haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ulnar nerve injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Upper limb fracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    8 / 3071 (0.26%)
         occurrences all number
    2
    8
    Vaccination complication
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences all number
    0
    4
    Vascular access site pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Vascular pseudoaneurysm thrombosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    9 / 3076 (0.29%)
    9 / 3071 (0.29%)
         occurrences all number
    9
    10
    Wound complication
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Wound dehiscence
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Wound haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Wound secretion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Wrist fracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    XIIth nerve injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Congenital coronary artery malformation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Congenital megaureter
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Congenital lip fistula
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dolichocolon
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gilbert's syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Heart disease congenital
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hereditary haemochromatosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hydrocele
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Myotonic dystrophy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Phimosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Porokeratosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rathke's cleft cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Thyroglossal cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Angina pectoris
         subjects affected / exposed
    114 / 3076 (3.71%)
    109 / 3071 (3.55%)
         occurrences all number
    125
    130
    Angina unstable
         subjects affected / exposed
    13 / 3076 (0.42%)
    10 / 3071 (0.33%)
         occurrences all number
    14
    11
    Anginal equivalent
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Aortic valve calcification
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Aortic valve incompetence
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Aortic valve sclerosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Aortic valve stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Arrhythmia
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Arteriospasm coronary
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    2
    Atrial fibrillation
         subjects affected / exposed
    70 / 3076 (2.28%)
    56 / 3071 (1.82%)
         occurrences all number
    84
    66
    Atrial flutter
         subjects affected / exposed
    9 / 3076 (0.29%)
    5 / 3071 (0.16%)
         occurrences all number
    11
    5
    Atrial thrombosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Atrial tachycardia
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Atrioventricular block complete
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Atrioventricular block first degree
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Bradycardia
         subjects affected / exposed
    34 / 3076 (1.11%)
    26 / 3071 (0.85%)
         occurrences all number
    36
    27
    Bundle branch block left
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bundle branch block right
         subjects affected / exposed
    6 / 3076 (0.20%)
    2 / 3071 (0.07%)
         occurrences all number
    7
    2
    Cardiac failure
         subjects affected / exposed
    26 / 3076 (0.85%)
    33 / 3071 (1.07%)
         occurrences all number
    27
    35
    Cardiac failure chronic
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences all number
    6
    2
    Cardiac failure congestive
         subjects affected / exposed
    9 / 3076 (0.29%)
    9 / 3071 (0.29%)
         occurrences all number
    9
    11
    Cardiac failure acute
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiac flutter
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    5
    Cardiac valve disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiogenic shock
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cardiomegaly
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cardiomyopathy
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Cardiovascular disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Chronotropic incompetence
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Conduction disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Coronary artery occlusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    2
    Coronary artery disease
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    7
    9
    Coronary artery stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Cyanosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Diastolic dysfunction
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    3
    Dilatation atrial
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Extrasystoles
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Heart valve incompetence
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Hepatojugular reflux
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Intracardiac thrombus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Left ventricular dysfunction
         subjects affected / exposed
    6 / 3076 (0.20%)
    2 / 3071 (0.07%)
         occurrences all number
    6
    2
    Left ventricular failure
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Left ventricular hypertrophy
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Mitral valve calcification
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Mitral valve incompetence
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Myocardial infarction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Myocarditis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Myocardial ischaemia
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences all number
    5
    8
    Nodal arrhythmia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Palpitations
         subjects affected / exposed
    66 / 3076 (2.15%)
    50 / 3071 (1.63%)
         occurrences all number
    70
    55
    Pericarditis
         subjects affected / exposed
    0 / 3076 (0.00%)
    5 / 3071 (0.16%)
         occurrences all number
    0
    6
    Pericardial effusion
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Prinzmetal angina
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Right ventricular failure
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sinoatrial block
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Sinus bradycardia
         subjects affected / exposed
    9 / 3076 (0.29%)
    7 / 3071 (0.23%)
         occurrences all number
    10
    7
    Sinus node dysfunction
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Sinus tachycardia
         subjects affected / exposed
    3 / 3076 (0.10%)
    8 / 3071 (0.26%)
         occurrences all number
    3
    11
    Supraventricular extrasystoles
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Supraventricular tachycardia
         subjects affected / exposed
    7 / 3076 (0.23%)
    8 / 3071 (0.26%)
         occurrences all number
    7
    8
    Tachycardia
         subjects affected / exposed
    11 / 3076 (0.36%)
    11 / 3071 (0.36%)
         occurrences all number
    13
    11
    Tricuspid valve incompetence
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences all number
    5
    2
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Ventricular extrasystoles
         subjects affected / exposed
    16 / 3076 (0.52%)
    16 / 3071 (0.52%)
         occurrences all number
    17
    16
    Ventricular fibrillation
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ventricular remodelling
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Ventricular tachycardia
         subjects affected / exposed
    7 / 3076 (0.23%)
    7 / 3071 (0.23%)
         occurrences all number
    8
    8
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Altered state of consciousness
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Amnesia
         subjects affected / exposed
    8 / 3076 (0.26%)
    13 / 3071 (0.42%)
         occurrences all number
    8
    13
    Anosmia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Aphasia
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Aphonia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Ataxia
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    5
    Burning sensation
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Carotid arteriosclerosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Carotid artery aneurysm
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Carotid artery occlusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Carotid artery disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Carotid artery insufficiency
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Carotid artery stenosis
         subjects affected / exposed
    8 / 3076 (0.26%)
    4 / 3071 (0.13%)
         occurrences all number
    9
    4
    Carpal tunnel syndrome
         subjects affected / exposed
    15 / 3076 (0.49%)
    12 / 3071 (0.39%)
         occurrences all number
    17
    13
    Cerebellar artery thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cerebellar microhaemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cerebral arteriosclerosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Cerebral atrophy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cerebral disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cerebral haematoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cerebral ischaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Cerebral microhaemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cervical myelopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cervical radiculopathy
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cluster headache
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cognitive disorder
         subjects affected / exposed
    6 / 3076 (0.20%)
    2 / 3071 (0.07%)
         occurrences all number
    6
    2
    Cubital tunnel syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dementia
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    5
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Demyelination
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Diabetic neuropathy
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences all number
    11
    8
    Disturbance in attention
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Dizziness
         subjects affected / exposed
    138 / 3076 (4.49%)
    147 / 3071 (4.79%)
         occurrences all number
    151
    166
    Dizziness exertional
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Dizziness postural
         subjects affected / exposed
    9 / 3076 (0.29%)
    8 / 3071 (0.26%)
         occurrences all number
    9
    8
    Dysaesthesia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Dysarthria
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Dysgeusia
         subjects affected / exposed
    9 / 3076 (0.29%)
    8 / 3071 (0.26%)
         occurrences all number
    10
    8
    Dyskinesia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Encephalopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Enlarged cerebral perivascular spaces
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Epilepsy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Essential tremor
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Facial neuralgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Facial paralysis
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Freezing phenomenon
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Head discomfort
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Headache
         subjects affected / exposed
    96 / 3076 (3.12%)
    142 / 3071 (4.62%)
         occurrences all number
    115
    165
    Hemianaesthesia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hemiparesis
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Hemiplegia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hydrocephalus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    27 / 3076 (0.88%)
    36 / 3071 (1.17%)
         occurrences all number
    30
    36
    Hypogeusia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hyposmia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Hypotonia
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    IIIrd nerve paralysis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    IVth nerve paralysis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Intracranial mass
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Lethargy
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    7
    9
    Leukoencephalopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Lumbar radiculopathy
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Memory impairment
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences all number
    10
    8
    Meralgia paraesthetica
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Migraine with aura
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Migraine
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences all number
    7
    8
    Motor dysfunction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Movement disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Multiple sclerosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Myelopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Myoclonus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Nerve compression
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Nervous system disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nerve root compression
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Neuralgia
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Neuropathy peripheral
         subjects affected / exposed
    13 / 3076 (0.42%)
    12 / 3071 (0.39%)
         occurrences all number
    13
    12
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Occipital neuralgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    29 / 3076 (0.94%)
    27 / 3071 (0.88%)
         occurrences all number
    29
    28
    Paralysis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Paresis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Parkinson's disease
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Parkinsonism
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Parosmia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Phantom pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Polyneuropathy
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Post-traumatic headache
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    19 / 3076 (0.62%)
    13 / 3071 (0.42%)
         occurrences all number
    22
    13
    Pseudoradicular syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Quadrantanopia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Radicular syndrome
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Radiculopathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Restless legs syndrome
         subjects affected / exposed
    6 / 3076 (0.20%)
    2 / 3071 (0.07%)
         occurrences all number
    6
    3
    Sciatica
         subjects affected / exposed
    27 / 3076 (0.88%)
    27 / 3071 (0.88%)
         occurrences all number
    27
    27
    Seizure
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Sinus headache
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    2
    Somnolence
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Speech disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Spinal cord disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    37 / 3076 (1.20%)
    32 / 3071 (1.04%)
         occurrences all number
    41
    35
    Tension headache
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Tongue biting
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Transient global amnesia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    5 / 3076 (0.16%)
    0 / 3071 (0.00%)
         occurrences all number
    5
    0
    Tremor
         subjects affected / exposed
    4 / 3076 (0.13%)
    10 / 3071 (0.33%)
         occurrences all number
    4
    11
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Ulnar neuritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ulnar tunnel syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vascular dementia
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Vertebral artery stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vertebral artery occlusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Visual field defect
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vocal cord paralysis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    White matter lesion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    62 / 3076 (2.02%)
    60 / 3071 (1.95%)
         occurrences all number
    65
    62
    Anaemia macrocytic
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Anaemia of chronic disease
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bone marrow oedema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Coagulopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Deficiency anaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eosinophilia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Haemorrhagic anaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Haemorrhagic diathesis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hilar lymphadenopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hypochromic anaemia
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    5
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Increased tendency to bruise
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Iron deficiency anaemia
         subjects affected / exposed
    18 / 3076 (0.59%)
    27 / 3071 (0.88%)
         occurrences all number
    18
    27
    Leukocytosis
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Leukopenia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Lymphadenopathy
         subjects affected / exposed
    3 / 3076 (0.10%)
    8 / 3071 (0.26%)
         occurrences all number
    3
    8
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Lymphopenia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Macrocytosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Microcytic anaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Neutropenia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Neutrophilia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Normochromic normocytic anaemia
         subjects affected / exposed
    6 / 3076 (0.20%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    4
    Pancytopenia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Pernicious anaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Polycythaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Spleen disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Splenic cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Splenomegaly
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Spontaneous haematoma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    5 / 3076 (0.16%)
    6 / 3071 (0.20%)
         occurrences all number
    5
    6
    Thrombocytosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    5
    Deafness
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Deafness bilateral
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    5
    Deafness neurosensory
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Deafness unilateral
         subjects affected / exposed
    1 / 3076 (0.03%)
    6 / 3071 (0.20%)
         occurrences all number
    1
    6
    Ear discomfort
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Ear haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Ear pain
         subjects affected / exposed
    5 / 3076 (0.16%)
    10 / 3071 (0.33%)
         occurrences all number
    6
    11
    Ear pruritus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ear swelling
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Eustachian tube disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Excessive cerumen production
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    External ear inflammation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Hypoacusis
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    6
    Inner ear disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Meniere's disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Middle ear effusion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Motion sickness
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Otorrhoea
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Presbyacusis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Sudden hearing loss
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    14 / 3076 (0.46%)
    15 / 3071 (0.49%)
         occurrences all number
    14
    15
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Vertigo
         subjects affected / exposed
    35 / 3076 (1.14%)
    30 / 3071 (0.98%)
         occurrences all number
    38
    31
    Vertigo positional
         subjects affected / exposed
    6 / 3076 (0.20%)
    5 / 3071 (0.16%)
         occurrences all number
    6
    5
    Vestibular disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Amaurosis fugax
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Amaurosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arteriosclerotic retinopathy
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Astigmatism
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Blepharitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Blindness
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Cataract nuclear
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    47 / 3076 (1.53%)
    40 / 3071 (1.30%)
         occurrences all number
    54
    47
    Chorioretinopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    6
    Conjunctival oedema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Diabetic retinopathy
         subjects affected / exposed
    6 / 3076 (0.20%)
    5 / 3071 (0.16%)
         occurrences all number
    7
    6
    Diabetic retinal oedema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Diplopia
         subjects affected / exposed
    6 / 3076 (0.20%)
    0 / 3071 (0.00%)
         occurrences all number
    6
    0
    Dry eye
         subjects affected / exposed
    4 / 3076 (0.13%)
    9 / 3071 (0.29%)
         occurrences all number
    4
    9
    Eye allergy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eye colour change
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eye discharge
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eye disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Eye haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Eye inflammation
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Eye irritation
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Eye oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Eye pruritus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Eye swelling
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Eyelid irritation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eyelid ptosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    5
    Eyelid oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    4 / 3071 (0.13%)
         occurrences all number
    1
    5
    Foreign body sensation in eyes
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Glaucoma
         subjects affected / exposed
    3 / 3076 (0.10%)
    8 / 3071 (0.26%)
         occurrences all number
    3
    8
    Hypermetropia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hyphaema
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Idiopathic orbital inflammation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Iridocyclitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Keratitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Lacrimation increased
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Macular degeneration
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Macular fibrosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Macular hole
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Macular oedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Meibomianitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Myopia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Neovascular age-related macular degeneration
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Ocular hypertension
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ocular ischaemic syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ocular vascular disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Open angle glaucoma
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Ophthalmic vein thrombosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Panophthalmitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Posterior capsule opacification
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Presbyopia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pterygium
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Retinal degeneration
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Retinal detachment
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences all number
    6
    3
    Retinal disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Retinal haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Retinal tear
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Retinal vein occlusion
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Retinopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Scleral pigmentation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Strabismus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sudden visual loss
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Trichiasis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ulcerative keratitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Vision blurred
         subjects affected / exposed
    15 / 3076 (0.49%)
    4 / 3071 (0.13%)
         occurrences all number
    16
    4
    Visual acuity reduced
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Visual impairment
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences all number
    2
    5
    Vitreous adhesions
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vitreous degeneration
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vitreous detachment
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Vitreous floaters
         subjects affected / exposed
    5 / 3076 (0.16%)
    0 / 3071 (0.00%)
         occurrences all number
    5
    0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    17 / 3076 (0.55%)
    17 / 3071 (0.55%)
         occurrences all number
    18
    17
    Abdominal distension
         subjects affected / exposed
    17 / 3076 (0.55%)
    23 / 3071 (0.75%)
         occurrences all number
    18
    25
    Abdominal hernia
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Abdominal pain
         subjects affected / exposed
    58 / 3076 (1.89%)
    76 / 3071 (2.47%)
         occurrences all number
    67
    81
    Abdominal pain lower
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Abdominal pain upper
         subjects affected / exposed
    54 / 3076 (1.76%)
    77 / 3071 (2.51%)
         occurrences all number
    57
    89
    Abdominal tenderness
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Abdominal wall mass
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Abnormal faeces
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences all number
    2
    5
    Anal erosion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    6 / 3076 (0.20%)
    0 / 3071 (0.00%)
         occurrences all number
    6
    0
    Anal fistula
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Anal haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Anal incontinence
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Anal pruritus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Aphthous ulcer
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Ascites
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Barrett's oesophagus
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Bowel movement irregularity
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Breath odour
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Burning mouth syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    5
    Change of bowel habit
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Chronic cheek biting
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Chronic gastritis
         subjects affected / exposed
    6 / 3076 (0.20%)
    5 / 3071 (0.16%)
         occurrences all number
    6
    5
    Coeliac disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Colitis ulcerative
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Colitis
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences all number
    6
    3
    Constipation
         subjects affected / exposed
    67 / 3076 (2.18%)
    69 / 3071 (2.25%)
         occurrences all number
    71
    75
    Crohn's disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Dental caries
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    8
    Diarrhoea
         subjects affected / exposed
    186 / 3076 (6.05%)
    300 / 3071 (9.77%)
         occurrences all number
    220
    378
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Diverticulum
         subjects affected / exposed
    14 / 3076 (0.46%)
    11 / 3071 (0.36%)
         occurrences all number
    14
    11
    Diverticulum intestinal
         subjects affected / exposed
    6 / 3076 (0.20%)
    8 / 3071 (0.26%)
         occurrences all number
    6
    8
    Diverticulum oesophageal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    11 / 3076 (0.36%)
    6 / 3071 (0.20%)
         occurrences all number
    11
    6
    Duodenitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    4
    Duodenal ulcer
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Dyschezia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    50 / 3076 (1.63%)
    58 / 3071 (1.89%)
         occurrences all number
    55
    64
    Dysphagia
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    6
    10
    Eosinophilic oesophagitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    4 / 3076 (0.13%)
    5 / 3071 (0.16%)
         occurrences all number
    4
    5
    Epiploic appendagitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Erosive oesophagitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Eructation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Faecalith
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Faeces discoloured
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Faeces hard
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Faeces soft
         subjects affected / exposed
    6 / 3076 (0.20%)
    5 / 3071 (0.16%)
         occurrences all number
    6
    5
    Femoral hernia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Flatulence
         subjects affected / exposed
    19 / 3076 (0.62%)
    15 / 3071 (0.49%)
         occurrences all number
    19
    15
    Food poisoning
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Frequent bowel movements
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Gastric dilatation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gastric disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    6 / 3071 (0.20%)
         occurrences all number
    1
    6
    Gastric polyps
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Gastric mucosal lesion
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gastric ulcer
         subjects affected / exposed
    10 / 3076 (0.33%)
    1 / 3071 (0.03%)
         occurrences all number
    10
    1
    Gastritis
         subjects affected / exposed
    32 / 3076 (1.04%)
    21 / 3071 (0.68%)
         occurrences all number
    33
    21
    Gastritis erosive
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    6
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gastroduodenitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Gastrointestinal disorder
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    8
    Gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gastrointestinal ulcer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gastrointestinal pain
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Gastrointestinal wall thickening
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    48 / 3076 (1.56%)
    51 / 3071 (1.66%)
         occurrences all number
    50
    51
    Gastrooesophageal sphincter insufficiency
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gingival bleeding
         subjects affected / exposed
    5 / 3076 (0.16%)
    6 / 3071 (0.20%)
         occurrences all number
    5
    6
    Gingival cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gingival pain
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Haematemesis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Haematochezia
         subjects affected / exposed
    5 / 3076 (0.16%)
    16 / 3071 (0.52%)
         occurrences all number
    5
    17
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Haemorrhoids
         subjects affected / exposed
    16 / 3076 (0.52%)
    17 / 3071 (0.55%)
         occurrences all number
    16
    18
    Haemorrhoids thrombosed
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    10 / 3076 (0.33%)
    12 / 3071 (0.39%)
         occurrences all number
    10
    12
    Hyperchlorhydria
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Hypoaesthesia oral
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Ileus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Infrequent bowel movements
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    17 / 3076 (0.55%)
    10 / 3071 (0.33%)
         occurrences all number
    18
    10
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Intestinal polyp
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    5
    8
    Intestinal prolapse
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    7 / 3071 (0.23%)
         occurrences all number
    0
    7
    Large intestinal stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    12 / 3076 (0.39%)
    17 / 3071 (0.55%)
         occurrences all number
    13
    17
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Lumbar hernia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Melaena
         subjects affected / exposed
    1 / 3076 (0.03%)
    7 / 3071 (0.23%)
         occurrences all number
    1
    7
    Mesenteric panniculitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Mouth ulceration
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences all number
    5
    2
    Nausea
         subjects affected / exposed
    66 / 3076 (2.15%)
    100 / 3071 (3.26%)
         occurrences all number
    76
    114
    Noninfective gingivitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Odynophagia
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Oesophageal discomfort
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Oesophageal food impaction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Oesophageal motility disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Oesophageal spasm
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Oesophagitis
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences all number
    5
    8
    Oesophagitis ulcerative
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Oral disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Oral pain
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Palatal disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pancreatic atrophy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pancreatic cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Pancreatic disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pancreatic steatosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis acute
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Pancreatitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Paraesthesia oral
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Peptic ulcer
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences all number
    0
    4
    Periodontal disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Periodontal inflammation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Poor dental condition
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Portal hypertensive gastropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Proctalgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Proctitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    25 / 3076 (0.81%)
    13 / 3071 (0.42%)
         occurrences all number
    25
    13
    Rectal polyp
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Rectal prolapse
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rectal stenosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Reflux gastritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Saliva altered
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Salivary duct obstruction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Salivary gland calculus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    3
    Salivary gland mass
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Salivary gland mucocoele
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Stomatitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Stress ulcer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Subileus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Swollen tongue
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Teeth brittle
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tongue discomfort
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tongue haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Tongue ulceration
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tooth disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Tooth impacted
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Toothache
         subjects affected / exposed
    14 / 3076 (0.46%)
    12 / 3071 (0.39%)
         occurrences all number
    14
    12
    Umbilical hernia
         subjects affected / exposed
    7 / 3076 (0.23%)
    7 / 3071 (0.23%)
         occurrences all number
    7
    7
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Varices oesophageal
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    38 / 3076 (1.24%)
    33 / 3071 (1.07%)
         occurrences all number
    46
    40
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Actinic keratosis
         subjects affected / exposed
    8 / 3076 (0.26%)
    14 / 3071 (0.46%)
         occurrences all number
    11
    15
    Alopecia
         subjects affected / exposed
    10 / 3076 (0.33%)
    6 / 3071 (0.20%)
         occurrences all number
    10
    6
    Angioedema
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Blister
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Blood blister
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bromhidrosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cold sweat
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Contusion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cutis laxa
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    6
    Dermal cyst
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    8
    Dermatitis
         subjects affected / exposed
    12 / 3076 (0.39%)
    5 / 3071 (0.16%)
         occurrences all number
    12
    5
    Dermatitis allergic
         subjects affected / exposed
    11 / 3076 (0.36%)
    1 / 3071 (0.03%)
         occurrences all number
    11
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dermatitis contact
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    7
    Dermatitis herpetiformis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Diabetic foot
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Diabetic ulcer
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Diffuse alopecia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Drug eruption
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Dry skin
         subjects affected / exposed
    7 / 3076 (0.23%)
    6 / 3071 (0.20%)
         occurrences all number
    8
    6
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    13 / 3076 (0.42%)
    12 / 3071 (0.39%)
         occurrences all number
    13
    13
    Eczema
         subjects affected / exposed
    11 / 3076 (0.36%)
    14 / 3071 (0.46%)
         occurrences all number
    11
    15
    Eczema asteatotic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Eczema nummular
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    8 / 3076 (0.26%)
    12 / 3071 (0.39%)
         occurrences all number
    9
    14
    Granulomatous dermatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hair colour changes
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hair disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hand dermatitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Hidradenitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    10 / 3076 (0.33%)
    12 / 3071 (0.39%)
         occurrences all number
    10
    12
    Hyperkeratosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    7
    Idiopathic urticaria
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Ingrowing nail
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Intertrigo
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Lichen planus
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Lichen sclerosus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Lichenoid keratosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Miliaria
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Nail discolouration
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nail disorder
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Nail toxicity
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Onychoclasis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Pain of skin
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Papule
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Parapsoriasis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Perivascular dermatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Petechiae
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Photosensitivity reaction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pityriasis rosea
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Precancerous skin lesion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    25 / 3076 (0.81%)
    35 / 3071 (1.14%)
         occurrences all number
    25
    41
    Pruritus allergic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Pruritus generalised
         subjects affected / exposed
    5 / 3076 (0.16%)
    2 / 3071 (0.07%)
         occurrences all number
    5
    3
    Psoriasis
         subjects affected / exposed
    2 / 3076 (0.07%)
    12 / 3071 (0.39%)
         occurrences all number
    2
    12
    Purpura
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pyoderma gangrenosum
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    45 / 3076 (1.46%)
    57 / 3071 (1.86%)
         occurrences all number
    51
    60
    Rash erythematous
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Rash follicular
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Rash generalised
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Rash macular
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Rash papular
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Rash pruritic
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Rash vesicular
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Rosacea
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Scab
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sebaceous gland disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sebaceous hyperplasia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Skin depigmentation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Skin discolouration
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Skin fissures
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Skin hyperpigmentation
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Skin irritation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Skin lesion
         subjects affected / exposed
    9 / 3076 (0.29%)
    15 / 3071 (0.49%)
         occurrences all number
    9
    16
    Skin mass
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Skin reaction
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Skin ulcer
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences all number
    15
    12
    Solar dermatitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Solar lentigo
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Stasis dermatitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Swelling face
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    4
    Toxic skin eruption
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    8 / 3076 (0.26%)
    10 / 3071 (0.33%)
         occurrences all number
    9
    10
    Vitiligo
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Yellow nail syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    26 / 3076 (0.85%)
    31 / 3071 (1.01%)
         occurrences all number
    36
    33
    Acute prerenal failure
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Albuminuria
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bladder discomfort
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Bladder diverticulum
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Bladder hypertrophy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bladder outlet obstruction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bladder prolapse
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Bladder spasm
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Bladder trabeculation
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Calculus bladder
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Calculus urinary
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Chromaturia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Chronic kidney disease
         subjects affected / exposed
    10 / 3076 (0.33%)
    10 / 3071 (0.33%)
         occurrences all number
    10
    10
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Diabetic nephropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    15 / 3076 (0.49%)
    14 / 3071 (0.46%)
         occurrences all number
    15
    14
    End stage renal disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Eosinophilic cystitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    36 / 3076 (1.17%)
    36 / 3071 (1.17%)
         occurrences all number
    37
    38
    Hydronephrosis
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Hypertensive nephropathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hypertonic bladder
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    3
    Lower urinary tract symptoms
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Microalbuminuria
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Micturition disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Micturition urgency
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Myoglobinuria
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nephrectasia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    14 / 3076 (0.46%)
    16 / 3071 (0.52%)
         occurrences all number
    14
    16
    Nephropathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Neurogenic bladder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    8 / 3076 (0.26%)
    6 / 3071 (0.20%)
         occurrences all number
    8
    6
    Oliguria
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    9 / 3076 (0.29%)
    7 / 3071 (0.23%)
         occurrences all number
    9
    7
    Polyuria
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Proteinuria
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    4
    Pyelocaliectasis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Renal artery stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    3
    Renal cyst
         subjects affected / exposed
    14 / 3076 (0.46%)
    17 / 3071 (0.55%)
         occurrences all number
    14
    17
    Renal colic
         subjects affected / exposed
    9 / 3076 (0.29%)
    7 / 3071 (0.23%)
         occurrences all number
    10
    7
    Renal failure
         subjects affected / exposed
    10 / 3076 (0.33%)
    4 / 3071 (0.13%)
         occurrences all number
    10
    4
    Renal disorder
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Renal impairment
         subjects affected / exposed
    11 / 3076 (0.36%)
    11 / 3071 (0.36%)
         occurrences all number
    13
    13
    Renal injury
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Renal mass
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Renal pain
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Renal tubular dysfunction
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Stress urinary incontinence
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Tubulointerstitial nephritis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Ureteric stenosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Ureterolithiasis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Urethral haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Urethral polyp
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Urethral stenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Urinary hesitation
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Urinary retention
         subjects affected / exposed
    16 / 3076 (0.52%)
    21 / 3071 (0.68%)
         occurrences all number
    19
    22
    Urinary incontinence
         subjects affected / exposed
    4 / 3076 (0.13%)
    8 / 3071 (0.26%)
         occurrences all number
    4
    9
    Urinary tract disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Urine abnormality
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Basedow's disease
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Diabetes insipidus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Euthyroid sick syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Goitre
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Haemorrhagic thyroid cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Hyperparathyroidism
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Hyperthyroidism
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Hypogonadism
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hypogonadism male
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    14 / 3076 (0.46%)
    32 / 3071 (1.04%)
         occurrences all number
    14
    32
    Myxoedema
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Primary hypogonadism
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Primary hypothyroidism
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Thyroid mass
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Thyroiditis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Ankle impingement
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    104 / 3076 (3.38%)
    113 / 3071 (3.68%)
         occurrences all number
    112
    122
    Arthritis
         subjects affected / exposed
    15 / 3076 (0.49%)
    11 / 3071 (0.36%)
         occurrences all number
    15
    12
    Arthritis climacteric
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Arthropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    121 / 3076 (3.93%)
    124 / 3071 (4.04%)
         occurrences all number
    132
    138
    Bone lesion
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Bone pain
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Bone swelling
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bursitis
         subjects affected / exposed
    14 / 3076 (0.46%)
    18 / 3071 (0.59%)
         occurrences all number
    15
    18
    Cervical spinal stenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Chondrocalcinosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Chondromalacia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Clubbing
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Coccydynia
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Costochondritis
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Crystal arthropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dupuytren's contracture
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Enthesopathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Exostosis
         subjects affected / exposed
    7 / 3076 (0.23%)
    1 / 3071 (0.03%)
         occurrences all number
    7
    1
    Extremity contracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Facet joint syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fibromyalgia
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Flank pain
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    6
    10
    Finger deformity
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Foot deformity
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    6
    Gouty arthritis
         subjects affected / exposed
    2 / 3076 (0.07%)
    7 / 3071 (0.23%)
         occurrences all number
    2
    8
    Groin pain
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Hip deformity
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hypotonia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Intervertebral disc disorder
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Intervertebral disc degeneration
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences all number
    6
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    16 / 3076 (0.52%)
    11 / 3071 (0.36%)
         occurrences all number
    17
    12
    Jaw cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Joint crepitation
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Joint contracture
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Joint hyperextension
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Joint effusion
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Joint range of motion decreased
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Joint stiffness
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Joint swelling
         subjects affected / exposed
    15 / 3076 (0.49%)
    14 / 3071 (0.46%)
         occurrences all number
    16
    14
    Kyphosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Limb discomfort
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Limb mass
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Lumbar spinal stenosis
         subjects affected / exposed
    4 / 3076 (0.13%)
    0 / 3071 (0.00%)
         occurrences all number
    4
    0
    Metatarsalgia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Mobility decreased
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Muscle atrophy
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Muscle contracture
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Muscle disorder
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Muscle fatigue
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Muscle haemorrhage
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    42 / 3076 (1.37%)
    48 / 3071 (1.56%)
         occurrences all number
    45
    50
    Muscle tightness
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Muscular weakness
         subjects affected / exposed
    9 / 3076 (0.29%)
    4 / 3071 (0.13%)
         occurrences all number
    10
    4
    Musculoskeletal chest pain
         subjects affected / exposed
    30 / 3076 (0.98%)
    36 / 3071 (1.17%)
         occurrences all number
    31
    40
    Musculoskeletal discomfort
         subjects affected / exposed
    6 / 3076 (0.20%)
    5 / 3071 (0.16%)
         occurrences all number
    7
    5
    Musculoskeletal pain
         subjects affected / exposed
    62 / 3076 (2.02%)
    63 / 3071 (2.05%)
         occurrences all number
    67
    67
    Musculoskeletal stiffness
         subjects affected / exposed
    3 / 3076 (0.10%)
    6 / 3071 (0.20%)
         occurrences all number
    3
    6
    Myalgia
         subjects affected / exposed
    106 / 3076 (3.45%)
    108 / 3071 (3.52%)
         occurrences all number
    116
    119
    Myofascial pain syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Myopathy
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Myositis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Neck pain
         subjects affected / exposed
    18 / 3076 (0.59%)
    30 / 3071 (0.98%)
         occurrences all number
    18
    30
    Osteitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Osteitis deformans
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    50 / 3076 (1.63%)
    51 / 3071 (1.66%)
         occurrences all number
    56
    55
    Osteochondrosis
         subjects affected / exposed
    4 / 3076 (0.13%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Osteomalacia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Osteopenia
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences all number
    3
    7
    Osteonecrosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Osteoporosis postmenopausal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Osteoporosis
         subjects affected / exposed
    6 / 3076 (0.20%)
    9 / 3071 (0.29%)
         occurrences all number
    6
    9
    Pain in extremity
         subjects affected / exposed
    94 / 3076 (3.06%)
    108 / 3071 (3.52%)
         occurrences all number
    105
    124
    Pain in jaw
         subjects affected / exposed
    6 / 3076 (0.20%)
    1 / 3071 (0.03%)
         occurrences all number
    6
    1
    Patellofemoral pain syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pathological fracture
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Periarthritis
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    8
    Peripheral arthritis
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Plantar fasciitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    5 / 3071 (0.16%)
         occurrences all number
    4
    5
    Polyarthritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Rhabdomyolysis
         subjects affected / exposed
    3 / 3076 (0.10%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Rheumatoid arthritis
         subjects affected / exposed
    6 / 3076 (0.20%)
    7 / 3071 (0.23%)
         occurrences all number
    6
    7
    Rotator cuff syndrome
         subjects affected / exposed
    23 / 3076 (0.75%)
    12 / 3071 (0.39%)
         occurrences all number
    25
    15
    Sacroiliitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Scleroderma
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Scoliosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Senile ankylosing vertebral hyperostosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sjogren's syndrome
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Somatic dysfunction
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Spinal column stenosis
         subjects affected / exposed
    4 / 3076 (0.13%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    7
    Spinal osteoarthritis
         subjects affected / exposed
    11 / 3076 (0.36%)
    11 / 3071 (0.36%)
         occurrences all number
    12
    13
    Spinal pain
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    6
    2
    Spondylitis
         subjects affected / exposed
    5 / 3076 (0.16%)
    0 / 3071 (0.00%)
         occurrences all number
    5
    0
    Spondylolisthesis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Spondylolysis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Synovial cyst
         subjects affected / exposed
    5 / 3076 (0.16%)
    4 / 3071 (0.13%)
         occurrences all number
    6
    4
    Synovitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tendon disorder
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Tendonitis
         subjects affected / exposed
    15 / 3076 (0.49%)
    18 / 3071 (0.59%)
         occurrences all number
    15
    20
    Tenosynovitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences all number
    0
    5
    Torticollis
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Trigger finger
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences all number
    5
    9
    Vertebral foraminal stenosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Abscess
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Abscess bacterial
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Abscess oral
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Acarodermatitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Acute hepatitis B
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    9 / 3076 (0.29%)
    14 / 3071 (0.46%)
         occurrences all number
    10
    19
    Amoebiasis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Anal abscess
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Arthritis bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bacteraemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Bacterial vaginosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bacterial infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Balanoposthitis infective
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Borrelia infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    69 / 3076 (2.24%)
    60 / 3071 (1.95%)
         occurrences all number
    81
    77
    Bronchitis bacterial
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Bronchitis pneumococcal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Bronchitis viral
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Burn infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Campylobacter infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Candida infection
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    5
    4
    Carbuncle
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Catheter site infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    27 / 3076 (0.88%)
    24 / 3071 (0.78%)
         occurrences all number
    29
    27
    Chorioretinitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Chronic sinusitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Clostridium difficile infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Conjunctivitis
         subjects affected / exposed
    13 / 3076 (0.42%)
    6 / 3071 (0.20%)
         occurrences all number
    15
    6
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Corona virus infection
         subjects affected / exposed
    84 / 3076 (2.73%)
    102 / 3071 (3.32%)
         occurrences all number
    84
    102
    Cystitis
         subjects affected / exposed
    16 / 3076 (0.52%)
    21 / 3071 (0.68%)
         occurrences all number
    27
    33
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dacryocystitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Dengue fever
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    4
    Dermatophytosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Dermatophytosis of nail
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Device related infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Diverticulitis
         subjects affected / exposed
    12 / 3076 (0.39%)
    14 / 3071 (0.46%)
         occurrences all number
    12
    16
    Ear infection
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences all number
    12
    9
    Ear infection bacterial
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Enterococcal infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Epididymitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    5
    Erysipelas
         subjects affected / exposed
    7 / 3076 (0.23%)
    3 / 3071 (0.10%)
         occurrences all number
    7
    3
    Escherichia infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Eye infection
         subjects affected / exposed
    3 / 3076 (0.10%)
    7 / 3071 (0.23%)
         occurrences all number
    4
    7
    Eyelid infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    5 / 3076 (0.16%)
    1 / 3071 (0.03%)
         occurrences all number
    5
    1
    Fungal infection
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Fungal skin infection
         subjects affected / exposed
    4 / 3076 (0.13%)
    4 / 3071 (0.13%)
         occurrences all number
    4
    5
    Furuncle
         subjects affected / exposed
    3 / 3076 (0.10%)
    6 / 3071 (0.20%)
         occurrences all number
    5
    7
    Gangrene
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gastric infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Gastric ulcer helicobacter
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gastritis viral
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Gastroenteritis
         subjects affected / exposed
    31 / 3076 (1.01%)
    29 / 3071 (0.94%)
         occurrences all number
    32
    30
    Gastroenteritis bacterial
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    2
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    10 / 3076 (0.33%)
    13 / 3071 (0.42%)
         occurrences all number
    11
    14
    Gastrointestinal infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Genital abscess
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Genital herpes
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Giardiasis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Gingival abscess
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    6
    Groin abscess
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Haemophilus infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Helicobacter gastritis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Helicobacter infection
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Hepatitis C
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    19 / 3076 (0.62%)
    28 / 3071 (0.91%)
         occurrences all number
    19
    28
    Hordeolum
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Human ehrlichiosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Incision site infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Infected bite
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Infected bunion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Infected dermal cyst
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Infected skin ulcer
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    4 / 3071 (0.13%)
         occurrences all number
    2
    4
    Infectious mononucleosis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Infection parasitic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    67 / 3076 (2.18%)
    72 / 3071 (2.34%)
         occurrences all number
    70
    76
    Kidney infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Labyrinthitis
         subjects affected / exposed
    7 / 3076 (0.23%)
    6 / 3071 (0.20%)
         occurrences all number
    7
    7
    Laryngitis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Liver abscess
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Localised infection
         subjects affected / exposed
    7 / 3076 (0.23%)
    10 / 3071 (0.33%)
         occurrences all number
    7
    10
    Lower respiratory tract infection
         subjects affected / exposed
    36 / 3076 (1.17%)
    45 / 3071 (1.47%)
         occurrences all number
    55
    53
    Lung abscess
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Lung infection
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Lyme disease
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Mastitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Mastoiditis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Myringitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Nail bed infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    103 / 3076 (3.35%)
    124 / 3071 (4.04%)
         occurrences all number
    134
    168
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Onychomycosis
         subjects affected / exposed
    7 / 3076 (0.23%)
    5 / 3071 (0.16%)
         occurrences all number
    7
    5
    Ophthalmic herpes simplex
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Oral candidiasis
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    6
    Oral fungal infection
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    6
    Oral herpes
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Oral infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Orchitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    4
    1
    Osteomyelitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    5 / 3071 (0.16%)
         occurrences all number
    0
    5
    Otitis externa
         subjects affected / exposed
    8 / 3076 (0.26%)
    3 / 3071 (0.10%)
         occurrences all number
    9
    3
    Otitis media
         subjects affected / exposed
    4 / 3076 (0.13%)
    6 / 3071 (0.20%)
         occurrences all number
    4
    7
    Otitis media acute
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Otitis media chronic
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Paronychia
         subjects affected / exposed
    2 / 3076 (0.07%)
    3 / 3071 (0.10%)
         occurrences all number
    2
    3
    Parotitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Periodontitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Periorbital cellulitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    10 / 3076 (0.33%)
    16 / 3071 (0.52%)
         occurrences all number
    10
    18
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 3076 (0.00%)
    5 / 3071 (0.16%)
         occurrences all number
    0
    5
    Pilonidal cyst
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    3
    Pneumonia
         subjects affected / exposed
    42 / 3076 (1.37%)
    46 / 3071 (1.50%)
         occurrences all number
    44
    51
    Pneumonia bacterial
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pneumonia viral
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Post procedural infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    3 / 3071 (0.10%)
         occurrences all number
    0
    3
    Post viral fatigue syndrome
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    3 / 3076 (0.10%)
    4 / 3071 (0.13%)
         occurrences all number
    3
    4
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Pulpitis dental
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Puncture site infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Pyelonephritis
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    5
    2
    Pyelonephritis chronic
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Pyuria
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rectal abscess
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    32 / 3076 (1.04%)
    32 / 3071 (1.04%)
         occurrences all number
    37
    33
    Respiratory tract infection viral
         subjects affected / exposed
    17 / 3076 (0.55%)
    19 / 3071 (0.62%)
         occurrences all number
    17
    23
    Rhinitis
         subjects affected / exposed
    5 / 3076 (0.16%)
    8 / 3071 (0.26%)
         occurrences all number
    5
    8
    Rhinovirus infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Root canal infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Rotavirus infection
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sepsis
         subjects affected / exposed
    1 / 3076 (0.03%)
    5 / 3071 (0.16%)
         occurrences all number
    1
    5
    Severe acute respiratory syndrome
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Sexually transmitted disease
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Sialoadenitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Sinusitis bacterial
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    3
    Sinusitis
         subjects affected / exposed
    35 / 3076 (1.14%)
    40 / 3071 (1.30%)
         occurrences all number
    50
    51
    Skin candida
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Skin infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    5 / 3071 (0.16%)
         occurrences all number
    3
    5
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    3
    2
    Streptococcal infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Subcutaneous abscess
         subjects affected / exposed
    2 / 3076 (0.07%)
    2 / 3071 (0.07%)
         occurrences all number
    2
    2
    Syphilis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    2
    Tinea capitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tinea cruris
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Tinea infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Tinea versicolour
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    9 / 3076 (0.29%)
    7 / 3071 (0.23%)
         occurrences all number
    9
    7
    Tooth abscess
         subjects affected / exposed
    10 / 3076 (0.33%)
    18 / 3071 (0.59%)
         occurrences all number
    11
    18
    Tooth infection
         subjects affected / exposed
    12 / 3076 (0.39%)
    13 / 3071 (0.42%)
         occurrences all number
    13
    14
    Tracheitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Tracheobronchitis
         subjects affected / exposed
    4 / 3076 (0.13%)
    5 / 3071 (0.16%)
         occurrences all number
    6
    5
    Tuberculosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    69 / 3076 (2.24%)
    81 / 3071 (2.64%)
         occurrences all number
    83
    92
    Urethritis
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    88 / 3076 (2.86%)
    100 / 3071 (3.26%)
         occurrences all number
    112
    135
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Urosepsis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    3
    1
    Varicella
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Varicella zoster virus infection
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Viral infection
         subjects affected / exposed
    15 / 3076 (0.49%)
    25 / 3071 (0.81%)
         occurrences all number
    16
    28
    Vestibular neuronitis
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Viral rhinitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Viral sinusitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    9 / 3076 (0.29%)
    6 / 3071 (0.20%)
         occurrences all number
    11
    6
    Vulvitis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Vulvovaginitis
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Wound infection
         subjects affected / exposed
    5 / 3076 (0.16%)
    9 / 3071 (0.29%)
         occurrences all number
    6
    10
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    0 / 3076 (0.00%)
    2 / 3071 (0.07%)
         occurrences all number
    0
    2
    Cachexia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    11 / 3076 (0.36%)
    20 / 3071 (0.65%)
         occurrences all number
    12
    20
    Dehydration
         subjects affected / exposed
    11 / 3076 (0.36%)
    11 / 3071 (0.36%)
         occurrences all number
    12
    11
    Diabetes mellitus
         subjects affected / exposed
    82 / 3076 (2.67%)
    63 / 3071 (2.05%)
         occurrences all number
    85
    65
    Diabetes mellitus inadequate control
         subjects affected / exposed
    6 / 3076 (0.20%)
    15 / 3071 (0.49%)
         occurrences all number
    6
    16
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Diabetic metabolic decompensation
         subjects affected / exposed
    5 / 3076 (0.16%)
    3 / 3071 (0.10%)
         occurrences all number
    5
    3
    Dyslipidaemia
         subjects affected / exposed
    12 / 3076 (0.39%)
    10 / 3071 (0.33%)
         occurrences all number
    12
    11
    Electrolyte imbalance
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fluid overload
         subjects affected / exposed
    1 / 3076 (0.03%)
    3 / 3071 (0.10%)
         occurrences all number
    1
    3
    Fluid retention
         subjects affected / exposed
    2 / 3076 (0.07%)
    1 / 3071 (0.03%)
         occurrences all number
    2
    1
    Folate deficiency
         subjects affected / exposed
    8 / 3076 (0.26%)
    12 / 3071 (0.39%)
         occurrences all number
    8
    12
    Food aversion
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Food intolerance
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Fructose intolerance
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Glucose tolerance impaired
         subjects affected / exposed
    24 / 3076 (0.78%)
    15 / 3071 (0.49%)
         occurrences all number
    24
    15
    Gout
         subjects affected / exposed
    33 / 3076 (1.07%)
    35 / 3071 (1.14%)
         occurrences all number
    38
    46
    Haemochromatosis
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Hyperglycaemia
         subjects affected / exposed
    16 / 3076 (0.52%)
    9 / 3071 (0.29%)
         occurrences all number
    16
    11
    Hypercholesterolaemia
         subjects affected / exposed
    6 / 3076 (0.20%)
    3 / 3071 (0.10%)
         occurrences all number
    6
    3
    Hyperinsulinaemic hypoglycaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    15 / 3076 (0.49%)
    11 / 3071 (0.36%)
         occurrences all number
    15
    11
    Hyperlipidaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    4 / 3071 (0.13%)
         occurrences all number
    0
    4
    Hypernatraemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    10 / 3076 (0.33%)
    15 / 3071 (0.49%)
         occurrences all number
    10
    15
    Hyperuricaemia
         subjects affected / exposed
    13 / 3076 (0.42%)
    14 / 3071 (0.46%)
         occurrences all number
    14
    14
    Hypervolaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    6 / 3076 (0.20%)
    2 / 3071 (0.07%)
         occurrences all number
    7
    2
    Hypocholesterolaemia
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    17 / 3076 (0.55%)
    17 / 3071 (0.55%)
         occurrences all number
    20
    20
    Hypokalaemia
         subjects affected / exposed
    24 / 3076 (0.78%)
    23 / 3071 (0.75%)
         occurrences all number
    28
    24
    Hypomagnesaemia
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences all number
    11
    8
    Hyponatraemia
         subjects affected / exposed
    11 / 3076 (0.36%)
    4 / 3071 (0.13%)
         occurrences all number
    11
    4
    Hypophosphataemia
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    4
    3
    Hypovolaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Impaired fasting glucose
         subjects affected / exposed
    3 / 3076 (0.10%)
    3 / 3071 (0.10%)
         occurrences all number
    3
    3
    Increased appetite
         subjects affected / exposed
    2 / 3076 (0.07%)
    0 / 3071 (0.00%)
         occurrences all number
    2
    0
    Insulin resistance
         subjects affected / exposed
    1 / 3076 (0.03%)
    1 / 3071 (0.03%)
         occurrences all number
    1
    1
    Iron deficiency
         subjects affected / exposed
    10 / 3076 (0.33%)
    8 / 3071 (0.26%)
         occurrences all number
    10
    8
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Lactic acidosis
         subjects affected / exposed
    1 / 3076 (0.03%)
    2 / 3071 (0.07%)
         occurrences all number
    1
    2
    Malnutrition
         subjects affected / exposed
    4 / 3076 (0.13%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Metabolic acidosis
         subjects affected / exposed
    3 / 3076 (0.10%)
    2 / 3071 (0.07%)
         occurrences all number
    4
    2
    Obesity
         subjects affected / exposed
    5 / 3076 (0.16%)
    7 / 3071 (0.23%)
         occurrences all number
    5
    7
    Overweight
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0
    Polydipsia
         subjects affected / exposed
    3 / 3076 (0.10%)
    0 / 3071 (0.00%)
         occurrences all number
    3
    0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 3076 (0.00%)
    1 / 3071 (0.03%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    32 / 3076 (1.04%)
    40 / 3071 (1.30%)
         occurrences all number
    32
    40
    Vitamin B12 deficiency
         subjects affected / exposed
    5 / 3076 (0.16%)
    6 / 3071 (0.20%)
         occurrences all number
    5
    6
    Vitamin D deficiency
         subjects affected / exposed
    7 / 3076 (0.23%)
    22 / 3071 (0.72%)
         occurrences all number
    7
    22
    Vitamin K deficiency
         subjects affected / exposed
    1 / 3076 (0.03%)
    0 / 3071 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2017
    The original protocol, dated 18 August 2015, was implemented globally. Subsequently, this global protocol was amended 4 times. Protocol Version 2 dated 07 September 2017: In the original protocol DAL-301, women of childbearing potential who were not simultaneously using two effective contraceptive methods, one of which being a barrier method, were excluded from participating, as noted in the minutes from the FDA End-of-Phase 2 meeting on June 16, 2015 and in agency email communication on July 22, 2015, pending the results from an additional hamster embryo-fetal development (EFD) study. On the basis of the completion and results of the additional requested testing in hamsters, as well as the prior testing that evaluated the embryo-fetal effects of dalcetrapib in rats and rabbits, the protocol was amended to allow women of childbearing potential to be included in the study if using only one (rather than two) forms of contraception. Protocol Version 2 was implemented globally with the following exceptions. Canada did not accept the change of allowing women of childbearing potential to enter the study using one instead of two forms of contraception. Belgium and Germany requested the addition of the word “highly” to the description of the requirement for at least one effective method of contraception to be used and required a separate version of the protocol as a result of that request.
    23 Feb 2018
    The original DAL-301 sample size and anticipated treatment effect was based on the pharmacogenomics evaluation in the dal-OUTCOMES study that demonstrated a 39% reduction in CV risk in subjects with the AA genotype at variant rs1967309 in the ADCY9 gene with dalcetrapib compared to placebo. The initial design of DAL-301 proposed that a 25% reduction was appropriate as a conservative estimate for this prospective study. The study protocol was subsequently amended to change the target number of patients with a primary endpoint from 434 to 582, so that the study would have 85% power (two-sided alpha of 0.05) to detect a relative risk reduction of 22%. The minimally detectable risk reduction under this plan is 15%. A 15% relative risk reduction has been used in the design of other cardiovascular endpoint studies, including other CETP trials, since this level of risk reduction would provide clinically significant medical benefit on top of statin therapy.
    04 Aug 2020
    The public health and safety concerns resulting from the COVID-19 pandemic resulted in challenges adhering to DAL-301 protocol-mandated study visits and corresponding study drug dispensation. Modifications to the protocol were made to help protect patient safety, while maintaining compliance with Good Clinical Practice Guidelines and minimizing risks to study integrity. These included allowing in-person patient visits to be replaced by phone visits or virtual visits, and for patient communication to occur through email and text message. Sponsor approval was required for patients taking study medication without blood pressure, pulse, or weight assessments for more than one year. Study medication was permitted to be dispensed within a study visit window or in advance through a secure delivery method. All study medication was appropriately handled and tracked to ensure compliance with stability parameters. Patients were provided directions to save their unused study medication materials (used and unused drug supply containers) to return at their next on-site visit. Study medication was also allowed to be returned by the patient to the site through a secure delivery method. Additionally, monitors were allowed to perform monitoring visits virtually when access to sites in-person was not available.
    11 Feb 2021
    Additional modifications to the protocol were made in response to the COVID-19 pandemic. The physical exam and vital signs (blood pressure, pulse, and weight) at the EOS Visit were made optional, performed whenever possible. This was done to ensure the safety of patients and study staff and in light of significant safety data already available on dalcetrapib. The physical exam and vital signs were also allowed to be performed outside of the clinical site (i.e., a remote location, the patient’s home, etc.) due to many sites that were closed or had limited access during the pandemic.

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32087417
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