Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

    Summary
    EudraCT number
    		 2008-008004-41
    Trial protocol
    		 GB   NL   SE   FR   DE   BE   ES   IT   GR  
    Global end of trial date
    25 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Jun 2018
    First version publication date
    09 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    COU-AA-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00887198
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    1000 U.S. Route 202 South, Raritan, NJ, United States, 08869
    Public contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    31 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to compare the clinical benefit of abiraterone acetate plus prednisone to placebo plus prednisone in men with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC), who were asymptomatic or mildly symptomatic.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Known instances of nonconformance were documented and are not considered to have had an impact on the overall conclusions of this study. Safety was evaluated throughout the study and included adverse events (AEs), serious adverse events (SAEs), routine chemical test (Hematology, chemistry, coagulation, urinalysis and Serum Lipids), vital signs, Electrocardiograms, Physical examinations and body weight.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2009
    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
    Australia: 132
    Country: Number of subjects enrolled
    Belgium: 42
    Country: Number of subjects enrolled
    Canada: 100
    Country: Number of subjects enrolled
    France: 53
    Country: Number of subjects enrolled
    Germany: 78
    Country: Number of subjects enrolled
    Greece: 14
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Netherlands: 30
    Country: Number of subjects enrolled
    Spain: 45
    Country: Number of subjects enrolled
    Sweden: 17
    Country: Number of subjects enrolled
    United Kingdom: 98
    Country: Number of subjects enrolled
    United States: 472
    Worldwide total number of subjects
    1088
    EEA total number of subjects
    384
    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)
    290
    From 65 to 84 years
    741
    85 years and over
    57

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 1088 subjects were randomized out of which 1082 (542 in Abiraterone Acetate [AA] group and 540 in placebo group) received the study drug. After Amendment 3, subjects receiving placebo and after amendment 4 those who were discontinued from placebo, but continuing in long-term follow up were crossed over to abiraterone acetate treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Abiraterone Acetate + Prednisone (AAP)
    Arm description
    		 Subjects received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abiraterone Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received prednisone 5 mg tablet orally twice daily, from Day 1 along with 1000 mg abiraterone acetate tablets (as 4*250 mg tablets) orally once daily.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 4 tablets of placebo matching to Abiraterone Acetate 250 mg orally along with prednisone 5 mg tablet orally twice daily.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received prednisone 5 mg tablet orally twice daily, from Day 1 along with 1000 mg abiraterone acetate tablets (as 4*250 mg tablets) orally once daily.

    Number of subjects in period 1
    		Abiraterone Acetate + Prednisone (AAP) Placebo
    Started
    546
    542
    Treated
    542
    540
    Total crossover to AA
    0
    93
    Completed
    0
    0
    Not completed
    546
    542
         Consent withdrawn by subject
    41
    56
         Cross-over to aa
    -
    51
         Lost to follow-up
    1
    -
         Adverse event, non-fatal
    50
    33
         Randomized, Not treated
    4
    2
         Ongoing
    42
    -
         Unspecified
    42
    30
         Progressive disease
    366
    370

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Abiraterone Acetate + Prednisone (AAP)
    Reporting group description
    		 Subjects received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

    Reporting group values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo Total
    Number of subjects
    		 546 542 1088
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    		 135 155 290
        From 65 to 84 years
    		 383 358 741
        85 years and over
    		 28 29 57
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.5 ( 8.8 ) 70.1 ( 8.72 ) -
    Title for Gender
    Units: subjects
        Male
    		 546 542 1088

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Abiraterone Acetate + Prednisone (AAP)
    Reporting group description
    		 Subjects received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

    Subject analysis set title
    Placebo to Abiraterone Acetate (AA)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.‌

    Primary: Overall Survival

    		 Close Top of page
    End point title
    		 Overall Survival
    End point description
    Overall survival is defined as the time from randomization to date of death from any cause. Intent-to-treat (ITT) population included all the randomized subjects who were classified according to their assigned treatment group, regardless of the actual treatment received.
    End point type
    Primary
    End point timeframe
    From randomization (Day 1) up to end of study (Month 60)
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    546
    542
    Units: Months
        median (confidence interval 95%)
    34.66 (32.72 to 36.80)
    30.29 (28.65 to 33.28)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Abiraterone Acetate + Prednisone (AAP) v Placebo
    Number of subjects included in analysis
    1088
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0033
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.806
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.697
         upper limit
    		 0.931

    Primary: Radiographic Progression-free Survival (rPFS)

    		 Close Top of page
    End point title
    		 Radiographic Progression-free Survival (rPFS)
    End point description
    The rPFS was defined as time from randomization to the occurrence of one of the following a subject was considered to have progressed by bone scan if a) the first bone scan with >= 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later; 2) progression of soft tissue lesions measured by computerized tomography (CT) or MRI 3) death from any cause. ITT population included all the randomized subjects who were classified according to their assigned treatment group, regardless of the actual treatment received. Here "99999" indicates data was not estimable due to insufficient number of subjects who had the event.
    End point type
    Primary
    End point timeframe
    From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    546
    542
    Units: Months
        median (confidence interval 95%)
    99999 (11.66 to 99999)
    8.28 (8.12 to 8.54)
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Abiraterone Acetate + Prednisone (AAP) v Placebo
    Number of subjects included in analysis
    1088
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.425
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.347
         upper limit
    		 0.522

    Secondary: Time to Opiate Use for Prostate Cancer Pain

    		 Close Top of page
    End point title
    		 Time to Opiate Use for Prostate Cancer Pain
    End point description
    The time interval from the date of randomization to the date of opiate use for cancer pain. Subjects who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Subjects with no assessment were censored at the date of randomization. ITT population included all the randomized subjects who were classified according to their assigned treatment group, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From randomization (Day 1) up to first opiate use or end of study (Month 60)
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    546
    542
    Units: Months
        median (confidence interval 95%)
    33.28 (30.23 to 39.75)
    23.39 (20.27 to 27.53)
    No statistical analyses for this end point

    Secondary: Time to Initiation of Cytotoxic Chemotherapy

    		 Close Top of page
    End point title
    		 Time to Initiation of Cytotoxic Chemotherapy
    End point description
    The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Subjects who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Subjects with no assessment were censored at the date of randomization. ITT population included all the randomized subjects who were classified according to their assigned treatment group, regardless of the actual treatment received. Here "99999" indicates data was not estimable due to insufficient number of subjects who had the event.
    End point type
    Secondary
    End point timeframe
    From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    546
    542
    Units: Months
        median (confidence interval 95%)
    25.17 (23.26 to 99999)
    16.82 (14.55 to 19.38)
    No statistical analyses for this end point

    Secondary: Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point

    		 Close Top of page
    End point title
    		 Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
    End point description
    The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Subjects who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Subjects with no assessment were censored at the date of randomization. ITT population included all the randomized subjects who were classified according to their assigned treatment group, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    546
    542
    Units: Months
        median (confidence interval 95%)
    12.29 (11.33 to 14.29)
    10.87 (9.49 to 11.76)
    No statistical analyses for this end point

    Secondary: Time to Prostate-specific Antigen (PSA) Progression

    		 Close Top of page
    End point title
    		 Time to Prostate-specific Antigen (PSA) Progression
    End point description
    The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A subjects was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Subjects who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Subjects with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization. ITT population included all the randomized subjects who were classified according to their assigned treatment group, regardless of the actual treatment received.
    End point type
    Secondary
    End point timeframe
    From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    546
    542
    Units: Months
        median (confidence interval 95%)
    11.07 (8.51 to 11.24)
    5.55 (5.39 to 5.59)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Safety analysis set included all subjects in the randomized population who received any study drug.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to 30 days after the last dose of study drug
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to Abiraterone Acetate (AA)
    Number of subjects analysed
    542
    540
    93
    Units: Subjects
        With Treatment-Emergent Adverse Events
    541
    524
    93
        With Treatment-Emergent Serious Adverse Events
    208
    148
    39
    No statistical analyses for this end point

    Secondary: Mean Plasma Concentrations of Abiraterone

    		 Close Top of page
    End point title
    		 Mean Plasma Concentrations of Abiraterone
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Cycle 5, Day 1
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: nanogram per milliliter (ng/ml)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [1] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    [2] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentrations of Abiraterone

    		 Close Top of page
    End point title
    		 Maximum Plasma Concentrations of Abiraterone
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Cycle 5, Day 1
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: nanogram per milliliter (ng/ml)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [3] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    [4] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-time Curve from Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])

    		 Close Top of page
    End point title
    		 Area Under the Plasma Concentration-time Curve from Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])
    End point description
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
    End point type
    Secondary
    End point timeframe
    Up to Cycle 5, Day 1
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: nanogram*hour per milliliter
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [5] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    [6] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    No statistical analyses for this end point

    Secondary: Elimination Half-Life (t1/2)

    		 Close Top of page
    End point title
    		 Elimination Half-Life (t1/2)
    End point description
    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
    End point type
    Secondary
    End point timeframe
    Up to Cycle 5, Day 1
    End point values
    		 Abiraterone Acetate + Prednisone (AAP) Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Hours
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [7] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    [8] - Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 30 days after the last dose of study drug
    Adverse event reporting additional description
    Safety analysis set included all subjects in the randomized population who received any study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Abiraterone Acetate + Prednisone (AAP)
    Reporting group description
    		 Subjects received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

    Reporting group title
    Placebo to AA
    Reporting group description
    		 Subjects who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.

    Serious adverse events
    		 Abiraterone Acetate + Prednisone (AAP) Placebo to AA Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    215 / 542 (39.67%)
    40 / 93 (43.01%)
    156 / 540 (28.89%)
         number of deaths (all causes)
    352
    24
    387
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-Cell Type Acute Leukaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cancer Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Central Nervous System Lymphoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Colorectal Cancer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Adenocarcinoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Neoplasm
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant Neoplasm of Ampulla of Vater
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to Meninges
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pancreatic Carcinoma
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral Cancer
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial Thrombosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolism Venous
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Embolism
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous Thrombosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Aortic Valve Replacement
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chemotherapy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Knee Arthroplasty
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatectomy
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transurethral Prostatectomy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter Related Complication
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Disease Progression
         subjects affected / exposed
    8 / 542 (1.48%)
    6 / 93 (6.45%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    1 / 5
    0 / 3
    0 / 2
    Fatigue
         subjects affected / exposed
    2 / 542 (0.37%)
    2 / 93 (2.15%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait Disturbance
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    Hypothermia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal Inflammation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Performance Status Decreased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Erectile Dysfunction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic Haemorrhage
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Dyspnoea
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Hypoxia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    10 / 542 (1.85%)
    1 / 93 (1.08%)
    12 / 540 (2.22%)
         occurrences causally related to treatment / all
    4 / 10
    0 / 2
    4 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillar Cyst
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Confusional State
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Uric Acid Increased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram St Segment Depression
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipase Increased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet Count Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal Scratch
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Perforation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract Operation Complication
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis Radiation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device Dislocation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Radiation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Anastomotic Leak
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implantable Defibrillator Malfunction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Narcotic Intoxication
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pubic Rami Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scapula Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skeletal Injury
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Laceration
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft Tissue Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    0 / 542 (0.00%)
    2 / 93 (2.15%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural Haemorrhage
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    11 / 542 (2.03%)
    0 / 93 (0.00%)
    8 / 540 (1.48%)
         occurrences causally related to treatment / all
    5 / 13
    0 / 0
    7 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bifascicular Block
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Cardiac Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conduction Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    4 / 542 (0.74%)
    2 / 93 (2.15%)
    5 / 540 (0.93%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    Myocardial Ischaemia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachyarrhythmia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic Lateral Sclerosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Cerebral Ischaemia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
    Convulsion
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolic Stroke
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Memory Impairment
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine with Aura
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nerve Root Compression
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurological Symptom
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Quadriparesis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope Vasovagal
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 542 (1.48%)
    1 / 93 (1.08%)
    6 / 540 (1.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    6 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Necrosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Ischaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Mass
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pancreatic Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Necrotising
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varices Oesophageal
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Obstruction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic Keratosis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lentigo
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Lesion
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder Mass
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Obstruction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Spasm
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Tamponade
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus Bladder
         subjects affected / exposed
    0 / 542 (0.00%)
    2 / 93 (2.15%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus Ureteric
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    11 / 542 (2.03%)
    3 / 93 (3.23%)
    5 / 540 (0.93%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage Urinary Tract
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive Uropathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric Obstruction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric Stenosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral Obstruction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone Pain
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flank Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw Cyst
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint Swelling
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    1 / 542 (0.18%)
    2 / 93 (2.15%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary Sepsis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis Infective
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter Gastroenteritis
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 542 (0.37%)
    2 / 93 (2.15%)
    3 / 540 (0.56%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Abscess
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Salmonella
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gingival Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective Exacerbation of Chronic Obstructive Airways Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Necrotising Fasciitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae Virus Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    10 / 542 (1.85%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    3 / 12
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    Pneumonia Influenzal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Staphylococcal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal Bacteraemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    7 / 542 (1.29%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    14 / 542 (2.58%)
    5 / 93 (5.38%)
    4 / 540 (0.74%)
         occurrences causally related to treatment / all
    8 / 17
    0 / 8
    1 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Failure to Thrive
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid Retention
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Abiraterone Acetate + Prednisone (AAP) Placebo to AA Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    540 / 542 (99.63%)
    88 / 93 (94.62%)
    524 / 540 (97.04%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic Neuroma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Acrochordon
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    2
    0
    4
    Atypical Fibroxanthoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Basal Cell Carcinoma
         subjects affected / exposed
    9 / 542 (1.66%)
    2 / 93 (2.15%)
    10 / 540 (1.85%)
         occurrences all number
    10
    2
    13
    Benign Neoplasm of Skin
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bladder Neoplasm
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bowen's Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cancer Pain
         subjects affected / exposed
    14 / 542 (2.58%)
    0 / 93 (0.00%)
    16 / 540 (2.96%)
         occurrences all number
    18
    0
    26
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Colon Adenoma
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Cystic Lymphangioma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Haemangioma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Keratoacanthoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    4
    Lip Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Lipoma
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    4
    1
    3
    Malignant Melanoma
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Melanocytic Naevus
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    0
    1
    1
    Metastases to Bone
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Metastatic Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Neoplasm Malignant
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Neurilemmoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal Cancer
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Renal Cell Carcinoma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Seborrhoeic Keratosis
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    7
    0
    4
    Skin Papilloma
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    3
    0
    4
    Spinal Cord Neoplasm
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Squamous Cell Carcinoma
         subjects affected / exposed
    11 / 542 (2.03%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    16
    3
    4
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Transitional Cell Carcinoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Tumour Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Vocal Cord Neoplasm
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Angiodysplasia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Aortic Aneurysm
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Aortic Arteriosclerosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Arterial Thrombosis Limb
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Capillary Fragility
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Circulatory Collapse
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Deep Vein Thrombosis
         subjects affected / exposed
    8 / 542 (1.48%)
    1 / 93 (1.08%)
    6 / 540 (1.11%)
         occurrences all number
    8
    1
    6
    Flushing
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    9
    0
    5
    Gastrointestinal Arteriovenous Malformation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Haematoma
         subjects affected / exposed
    22 / 542 (4.06%)
    1 / 93 (1.08%)
    6 / 540 (1.11%)
         occurrences all number
    32
    1
    6
    Haemorrhage
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Hot Flush
         subjects affected / exposed
    124 / 542 (22.88%)
    6 / 93 (6.45%)
    100 / 540 (18.52%)
         occurrences all number
    153
    6
    122
    Hypertension
         subjects affected / exposed
    129 / 542 (23.80%)
    6 / 93 (6.45%)
    73 / 540 (13.52%)
         occurrences all number
    182
    8
    94
    Hypotension
         subjects affected / exposed
    24 / 542 (4.43%)
    3 / 93 (3.23%)
    16 / 540 (2.96%)
         occurrences all number
    24
    4
    19
    Intermittent Claudication
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Lymphoedema
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Microangiopathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Orthostatic Hypotension
         subjects affected / exposed
    5 / 542 (0.92%)
    2 / 93 (2.15%)
    4 / 540 (0.74%)
         occurrences all number
    5
    2
    4
    Pallor
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Peripheral Ischaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Peripheral Vascular Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Thrombophlebitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Thrombophlebitis Superficial
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombosis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Varicose Vein
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    1
    0
    4
    Vein Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Venous Thrombosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Venous Thrombosis Limb
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Surgical and medical procedures
    Cataract Operation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    2
    Knee Arthroplasty
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Neoplasm Excision
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Transurethral Prostatectomy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Ureteral Stent Insertion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Wisdom Teeth Removal
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Abasia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Adverse Drug Reaction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Asthenia
         subjects affected / exposed
    46 / 542 (8.49%)
    1 / 93 (1.08%)
    46 / 540 (8.52%)
         occurrences all number
    65
    1
    66
    Axillary Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Catheter Related Complication
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    0
    0
    7
    Catheter Site Erythema
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Catheter Site Haematoma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Catheter Site Haemorrhage
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Catheter Site Inflammation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Catheter Site Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    8
    Chest Discomfort
         subjects affected / exposed
    10 / 542 (1.85%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    10
    0
    8
    Chest Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    2
    1
    8
    Chills
         subjects affected / exposed
    15 / 542 (2.77%)
    2 / 93 (2.15%)
    14 / 540 (2.59%)
         occurrences all number
    17
    2
    17
    Cyst
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    2
    Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Disease Progression
         subjects affected / exposed
    3 / 542 (0.55%)
    2 / 93 (2.15%)
    1 / 540 (0.19%)
         occurrences all number
    3
    2
    1
    Energy Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Extravasation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Face Oedema
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    6
    0
    4
    Facial Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Fatigue
         subjects affected / exposed
    243 / 542 (44.83%)
    27 / 93 (29.03%)
    200 / 540 (37.04%)
         occurrences all number
    448
    35
    314
    Feeling Abnormal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Feeling Cold
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    2
    1
    1
    Feeling Hot
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    2
    Feeling Jittery
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    2
    Gait Disturbance
         subjects affected / exposed
    10 / 542 (1.85%)
    0 / 93 (0.00%)
    10 / 540 (1.85%)
         occurrences all number
    12
    0
    12
    General Physical Health Deterioration
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    8
    0
    3
    Generalised Oedema
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Hangover
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Hernia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Hernia Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    3
    1
    0
    Hunger
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hyperthermia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Hypothermia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Impaired Healing
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Implant Site Inflammation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Implant Site Reaction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Inflammation
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Influenza Like Illness
         subjects affected / exposed
    20 / 542 (3.69%)
    4 / 93 (4.30%)
    10 / 540 (1.85%)
         occurrences all number
    27
    4
    14
    Infusion Site Bruising
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Bruising
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Injection Site Haematoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Injection Site Reaction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Irritability
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    7
    0
    5
    Local Swelling
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Localised Oedema
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    5
    0
    1
    Malaise
         subjects affected / exposed
    10 / 542 (1.85%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    12
    0
    7
    Mass
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    2
    1
    2
    Mucosal Inflammation
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    9
    0
    2
    Multi-Organ Failure
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Nodule
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    6
    0
    1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    13 / 542 (2.40%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    13
    1
    14
    Oedema Peripheral
         subjects affected / exposed
    148 / 542 (27.31%)
    22 / 93 (23.66%)
    119 / 540 (22.04%)
         occurrences all number
    269
    24
    198
    Pain
         subjects affected / exposed
    27 / 542 (4.98%)
    0 / 93 (0.00%)
    16 / 540 (2.96%)
         occurrences all number
    28
    0
    18
    Papillitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic Mass
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Performance Status Decreased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Peripheral Coldness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Pitting Oedema
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    4
    0
    6
    Puncture Site Reaction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    54 / 542 (9.96%)
    5 / 93 (5.38%)
    33 / 540 (6.11%)
         occurrences all number
    69
    7
    45
    Sensation of Pressure
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Suprapubic Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Temperature Intolerance
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Thirst
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Venipuncture Site Swelling
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Vessel Puncture Site Haematoma
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Wound Necrosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Xerosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Contrast Media Allergy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hypersensitivity
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    3
    0
    4
    Seasonal Allergy
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    5 / 540 (0.93%)
         occurrences all number
    8
    2
    5
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Breast Mass
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Breast Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Breast Tenderness
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    4
    Epididymal Cyst
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Erectile Dysfunction
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    9
    0
    2
    Genital Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Nipple Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Oedema Genital
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Penile Discharge
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Penile Oedema
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Penile Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    6
    0
    2
    Penile Size Reduced
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Perineal Pain
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    7
    0
    3
    Prostate Induration
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatic Obstruction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Prostatic Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatism
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Prostatitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Scrotal Haematocoele
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Scrotal Oedema
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Scrotal Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    3
    1
    1
    Testicular Atrophy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Testicular Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Testicular Pain
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    8
    0
    2
    Testicular Swelling
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    4
    Testis Discomfort
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Asthma
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    5
    0
    1
    Atelectasis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    3
    0
    3
    Bronchopneumopathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bronchospasm
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Chest Discomfort
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Chest Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    3 / 542 (0.55%)
    2 / 93 (2.15%)
    4 / 540 (0.74%)
         occurrences all number
    4
    2
    4
    Cough
         subjects affected / exposed
    106 / 542 (19.56%)
    11 / 93 (11.83%)
    74 / 540 (13.70%)
         occurrences all number
    146
    14
    92
    Dry Throat
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Dysphonia
         subjects affected / exposed
    17 / 542 (3.14%)
    0 / 93 (0.00%)
    6 / 540 (1.11%)
         occurrences all number
    18
    0
    6
    Dyspnoea
         subjects affected / exposed
    71 / 542 (13.10%)
    7 / 93 (7.53%)
    52 / 540 (9.63%)
         occurrences all number
    116
    8
    74
    Dyspnoea Exertional
         subjects affected / exposed
    16 / 542 (2.95%)
    0 / 93 (0.00%)
    13 / 540 (2.41%)
         occurrences all number
    21
    0
    13
    Emphysema
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    1
    0
    3
    Epistaxis
         subjects affected / exposed
    12 / 542 (2.21%)
    1 / 93 (1.08%)
    9 / 540 (1.67%)
         occurrences all number
    13
    1
    10
    Haemoptysis
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    2
    1
    0
    Hiccups
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoxia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Increased Bronchial Secretion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Increased Upper Airway Secretion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    3
    Interstitial Lung Disease
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Lung Infiltration
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Nasal Congestion
         subjects affected / exposed
    20 / 542 (3.69%)
    0 / 93 (0.00%)
    14 / 540 (2.59%)
         occurrences all number
    26
    0
    18
    Nasal Mucosal Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal Septum Deviation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Orthopnoea
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Paranasal Sinus Hypersecretion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Pharyngeal Erythema
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngolaryngeal Discomfort
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Pharyngolaryngeal Pain
         subjects affected / exposed
    21 / 542 (3.87%)
    4 / 93 (4.30%)
    13 / 540 (2.41%)
         occurrences all number
    29
    4
    14
    Pleural Effusion
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    5
    0
    3
    Pleuritic Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Pneumothorax
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Postnasal Drip
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    3
    0
    3
    Productive Cough
         subjects affected / exposed
    17 / 542 (3.14%)
    0 / 93 (0.00%)
    11 / 540 (2.04%)
         occurrences all number
    23
    0
    13
    Prolonged Expiration
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary Embolism
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    8 / 540 (1.48%)
         occurrences all number
    5
    0
    9
    Pulmonary Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary Hypertension
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Rales
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    4
    0
    4
    Respiratory Distress
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Respiratory Failure
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Respiratory Tract Congestion
         subjects affected / exposed
    10 / 542 (1.85%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    14
    0
    4
    Respiratory Tract Haemorrhage
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    12
    0
    4
    Rhinitis Allergic
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    13 / 542 (2.40%)
    0 / 93 (0.00%)
    9 / 540 (1.67%)
         occurrences all number
    14
    0
    9
    Rhonchi
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Sinus Congestion
         subjects affected / exposed
    9 / 542 (1.66%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences all number
    21
    1
    4
    Sinus Polyp
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Sputum Discoloured
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Tachypnoea
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Throat Irritation
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Tracheal Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Upper Respiratory Tract Congestion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Wheezing
         subjects affected / exposed
    8 / 542 (1.48%)
    2 / 93 (2.15%)
    7 / 540 (1.30%)
         occurrences all number
    9
    2
    7
    Psychiatric disorders
    Abnormal Dreams
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Affect Lability
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Affective Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Aggression
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Agitation
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    4
    0
    6
    Alcoholism
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Anxiety
         subjects affected / exposed
    30 / 542 (5.54%)
    4 / 93 (4.30%)
    23 / 540 (4.26%)
         occurrences all number
    38
    4
    25
    Bipolar Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Bulimia Nervosa
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Claustrophobia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Confusional State
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    10 / 540 (1.85%)
         occurrences all number
    7
    2
    13
    Delirium
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Depressed Mood
         subjects affected / exposed
    12 / 542 (2.21%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    16
    1
    8
    Depression
         subjects affected / exposed
    32 / 542 (5.90%)
    3 / 93 (3.23%)
    19 / 540 (3.52%)
         occurrences all number
    41
    3
    20
    Disorientation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Elevated Mood
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Emotional Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Hallucination, Visual
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Impatience
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    82 / 542 (15.13%)
    5 / 93 (5.38%)
    62 / 540 (11.48%)
         occurrences all number
    112
    5
    67
    Libido Decreased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Loss of Libido
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Mania
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Mental Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Mental Disorder Due to A General Medical Condition
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Middle Insomnia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Mood Altered
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    8 / 540 (1.48%)
         occurrences all number
    9
    0
    8
    Mood Swings
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    1
    0
    4
    Nervousness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Panic Attack
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pressure of Speech
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Seasonal Affective Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Sleep Disorder
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    6
    1
    7
    Somnambulism
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Stress
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Suicidal Ideation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Suspiciousness
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Tearfulness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Activated Partial Thromboplastin Time Prolonged
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Activated Partial Thromboplastin Time Shortened
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Alanine Aminotransferase Increased
         subjects affected / exposed
    70 / 542 (12.92%)
    3 / 93 (3.23%)
    26 / 540 (4.81%)
         occurrences all number
    167
    6
    40
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    63 / 542 (11.62%)
    4 / 93 (4.30%)
    25 / 540 (4.63%)
         occurrences all number
    114
    4
    35
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    22 / 542 (4.06%)
    4 / 93 (4.30%)
    25 / 540 (4.63%)
         occurrences all number
    43
    4
    36
    Blood Amylase Increased
         subjects affected / exposed
    8 / 542 (1.48%)
    2 / 93 (2.15%)
    4 / 540 (0.74%)
         occurrences all number
    19
    7
    10
    Blood Bicarbonate Decreased
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    5
    1
    2
    Blood Calcium Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Blood Calcium Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Blood Chloride Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Cortisol Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Creatinine Increased
         subjects affected / exposed
    21 / 542 (3.87%)
    2 / 93 (2.15%)
    15 / 540 (2.78%)
         occurrences all number
    30
    2
    22
    Blood Folate Decreased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Blood Glucose Fluctuation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    6 / 540 (1.11%)
         occurrences all number
    7
    0
    7
    Blood Magnesium Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Magnesium Increased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Blood Parathyroid Hormone Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Blood Phosphorus Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Thyroid Stimulating Hormone Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blood Urea Increased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Blood Uric Acid Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Blood Uric Acid Increased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    2
    0
    9
    Body Temperature Increased
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Brain Natriuretic Peptide Increased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Breath Sounds Abnormal
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    2
    0
    3
    Carbon Dioxide Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cardiac Murmur
         subjects affected / exposed
    8 / 542 (1.48%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    13
    1
    5
    Electrocardiogram Abnormal
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Ejection Fraction Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Electrocardiogram Pr Prolongation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    11
    0
    4
    Electrocardiogram St Segment Depression
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram QT Shortened
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Electrocardiogram T Wave Inversion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    5
    0
    6
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Haematocrit Decreased
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    5
    0
    3
    Heart Rate Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Heart Rate Irregular
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    5
    0
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Inspiratory Capacity Decreased
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    International Normalised Ratio Decreased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    International Normalised Ratio Increased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Intraocular Pressure Increased
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    1
    1
    2
    Lasegue's Test Positive
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Lipase Increased
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    6
    Liver Function Test Abnormal
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    5
    0
    0
    Liver Palpable Subcostal
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Lymph Node Palpable
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Lymphocyte Count Decreased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    7
    0
    3
    Lymphocyte Count Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    2
    0
    Lymphocyte Percentage Decreased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    5
    0
    2
    Neutrophil Count Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Neutrophil Count Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Neutrophil Percentage Decreased
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Platelet Count Decreased
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    10
    1
    1
    Platelet Count Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    0
    1
    1
    Prostatic Specific Antigen Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    0
    0
    3
    Protein Total Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Prothrombin Time Prolonged
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Prothrombin Time Shortened
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    QRS Axis Abnormal
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Red Blood Cell Count Decreased
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    5
    0
    1
    Troponin I Increased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary Sediment Abnormal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary Sediment Present
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Urine Colour Abnormal
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Urine Output Increased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Vitamin B12 Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin D Decreased
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Waist Circumference Increased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    2
    0
    4
    Weight Decreased
         subjects affected / exposed
    42 / 542 (7.75%)
    6 / 93 (6.45%)
    27 / 540 (5.00%)
         occurrences all number
    66
    6
    38
    Weight Increased
         subjects affected / exposed
    29 / 542 (5.35%)
    2 / 93 (2.15%)
    40 / 540 (7.41%)
         occurrences all number
    43
    2
    48
    White Blood Cell Count Decreased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    6
    0
    3
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    0
    2
    3
    Injury, poisoning and procedural complications
    Accident at Home
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Accidental Overdose
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Alcohol Poisoning
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Animal Bite
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Arthropod Bite
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    8
    0
    3
    Arthropod Sting
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Back Injury
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    3
    1
    3
    Bone Fragmentation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cartilage Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Chest Injury
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Clavicle Fracture
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    3
    1
    0
    Concussion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Contrast Media Reaction
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences all number
    4
    1
    7
    Contusion
         subjects affected / exposed
    81 / 542 (14.94%)
    6 / 93 (6.45%)
    49 / 540 (9.07%)
         occurrences all number
    116
    10
    72
    Corneal Abrasion
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Cystitis Radiation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Device Breakage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Excoriation
         subjects affected / exposed
    15 / 542 (2.77%)
    2 / 93 (2.15%)
    11 / 540 (2.04%)
         occurrences all number
    20
    3
    12
    Eye Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Eye Penetration
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Face Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Facial Bones Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    47 / 542 (8.67%)
    12 / 93 (12.90%)
    20 / 540 (3.70%)
         occurrences all number
    60
    13
    29
    Fibula Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Foot Fracture
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    2
    1
    3
    Foreign Body in Eye
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Gastroenteritis Radiation
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Hand Fracture
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    2
    1
    0
    Head Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Hip Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Humerus Fracture
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Iliotibial Band Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Incisional Hernia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Joint Dislocation
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Joint Injury
         subjects affected / exposed
    7 / 542 (1.29%)
    4 / 93 (4.30%)
    3 / 540 (0.56%)
         occurrences all number
    7
    4
    4
    Joint Sprain
         subjects affected / exposed
    12 / 542 (2.21%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    13
    0
    3
    Laceration
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Ligament Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Ligament Rupture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Limb Injury
         subjects affected / exposed
    8 / 542 (1.48%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    8
    1
    2
    Lumbar Vertebral Fracture
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    2
    1
    0
    Meniscus Lesion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Mouth Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Muscle Rupture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle Strain
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    3 / 540 (0.56%)
         occurrences all number
    7
    2
    3
    Neck Injury
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Open Wound
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    0
    0
    3
    Patella Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Periorbital Haematoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Post Procedural Complication
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    3
    Post Procedural Discharge
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Post Procedural Discomfort
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Post Procedural Haematuria
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Post-Traumatic Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Procedural Pain
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    11
    0
    7
    Radiation Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Radiation Skin Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Radius Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Rib Fracture
         subjects affected / exposed
    20 / 542 (3.69%)
    2 / 93 (2.15%)
    20 / 540 (3.70%)
         occurrences all number
    26
    3
    24
    Scapula Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Scratch
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Seroma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Skeletal Injury
         subjects affected / exposed
    11 / 542 (2.03%)
    2 / 93 (2.15%)
    9 / 540 (1.67%)
         occurrences all number
    12
    2
    9
    Skin Injury
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Skin Laceration
         subjects affected / exposed
    13 / 542 (2.40%)
    6 / 93 (6.45%)
    15 / 540 (2.78%)
         occurrences all number
    24
    10
    21
    Soft Tissue Injury
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Spinal Compression Fracture
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    5
    1
    3
    Spinal Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Stent Occlusion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Stress Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Subdural Haematoma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Tendon Injury
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Tendon Rupture
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    4
    Tibia Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth Fracture
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    8
    0
    5
    Traumatic Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Upper Limb Fracture
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    0
    1
    1
    Wound
         subjects affected / exposed
    11 / 542 (2.03%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    15
    1
    7
    Wound Complication
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Wrist Fracture
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Phimosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    12 / 542 (2.21%)
    0 / 93 (0.00%)
    9 / 540 (1.67%)
         occurrences all number
    12
    0
    11
    Angina Unstable
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Aortic Valve Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Aortic Valve Incompetence
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Arrhythmia
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    8
    0
    4
    Arrhythmia Supraventricular
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Atrial Fibrillation
         subjects affected / exposed
    24 / 542 (4.43%)
    3 / 93 (3.23%)
    22 / 540 (4.07%)
         occurrences all number
    30
    6
    27
    Atrial Flutter
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Atrial Tachycardia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Atrioventricular Block First Degree
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Bradycardia
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    5
    0
    4
    Bundle Branch Block Left
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bundle Branch Block Right
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Cardiac Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cardiac Failure
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Cardiac Failure Acute
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac Failure Congestive
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    7
    0
    1
    Cardiac Flutter
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Cardiac Hypertrophy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiomegaly
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cardiovascular Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Chest Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Chest Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Conduction Disorder
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Extrasystoles
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    3
    0
    4
    Coronary Artery Disease
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Hypertrophic Cardiomyopathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Left Ventricular Dysfunction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Left Ventricular Hypertrophy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Mitral Valve Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Myocardial Infarction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Myocardial Ischaemia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    6 / 540 (1.11%)
         occurrences all number
    2
    0
    7
    Palpitations
         subjects affected / exposed
    14 / 542 (2.58%)
    0 / 93 (0.00%)
    9 / 540 (1.67%)
         occurrences all number
    15
    0
    12
    Right Ventricular Failure
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Sick Sinus Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Sinus Arrhythmia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Sinus Bradycardia
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    5
    0
    3
    Sinus Tachycardia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    2
    Supraventricular Tachycardia
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    4
    1
    1
    Tachyarrhythmia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    14 / 542 (2.58%)
    2 / 93 (2.15%)
    9 / 540 (1.67%)
         occurrences all number
    15
    2
    11
    Tricuspid Valve Incompetence
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Ventricular Extrasystoles
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    4
    0
    3
    Wandering Pacemaker
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    2
    Amnesia
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    7
    1
    3
    Aphasia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    4
    Aphonia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Ataxia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Balance Disorder
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    5
    1
    13
    Bradykinesia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Brain Injury
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Burning Sensation
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    7
    0
    2
    Carotid Arteriosclerosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Cerebral Atrophy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Cerebral Microangiopathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    0
    0
    3
    Cluster Headache
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cognitive Disorder
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    7
    1
    4
    Convulsion
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    2
    3
    1
    Coordination Abnormal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Dementia Alzheimer's Type
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Diabetic Autonomic Neuropathy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetic Neuropathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Disturbance in Attention
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Dizziness
         subjects affected / exposed
    81 / 542 (14.94%)
    7 / 93 (7.53%)
    73 / 540 (13.52%)
         occurrences all number
    116
    9
    95
    Dizziness Postural
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    3
    0
    6
    Drooling
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Dysaesthesia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Dysarthria
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Dysgeusia
         subjects affected / exposed
    19 / 542 (3.51%)
    1 / 93 (1.08%)
    15 / 540 (2.78%)
         occurrences all number
    19
    1
    15
    Dyskinesia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Dysphasia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Encephalopathy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Epidural Lipomatosis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Epiduritis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Epilepsy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Extrapyramidal Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Facial Neuralgia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Facial Paresis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Global Amnesia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Head Discomfort
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    1
    1
    0
    Headache
         subjects affected / exposed
    86 / 542 (15.87%)
    9 / 93 (9.68%)
    66 / 540 (12.22%)
         occurrences all number
    129
    9
    87
    Hydrocephalus
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    1
    0
    3
    Hypoaesthesia
         subjects affected / exposed
    18 / 542 (3.32%)
    0 / 93 (0.00%)
    12 / 540 (2.22%)
         occurrences all number
    22
    0
    15
    Hypoaesthesia Facial
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Hypogeusia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hypoglossal Nerve Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Hyposmia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Iiird Nerve Paralysis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Loss of Consciousness
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Memory Impairment
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    9 / 540 (1.67%)
         occurrences all number
    7
    1
    9
    Migraine
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    2
    Migraine with Aura
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Monoplegia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Motor Dysfunction
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Myoclonus
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Nerve Compression
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    3 / 540 (0.56%)
         occurrences all number
    8
    3
    3
    Neuropathy Peripheral
         subjects affected / exposed
    12 / 542 (2.21%)
    7 / 93 (7.53%)
    6 / 540 (1.11%)
         occurrences all number
    23
    7
    6
    Nystagmus
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    25 / 542 (4.61%)
    1 / 93 (1.08%)
    17 / 540 (3.15%)
         occurrences all number
    33
    2
    18
    Parkinson's Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Parosmia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Peripheral Motor Neuropathy
         subjects affected / exposed
    6 / 542 (1.11%)
    2 / 93 (2.15%)
    1 / 540 (0.19%)
         occurrences all number
    8
    2
    1
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    13 / 542 (2.40%)
    0 / 93 (0.00%)
    13 / 540 (2.41%)
         occurrences all number
    24
    0
    17
    Peroneal Nerve Palsy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Polyneuropathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Poor Quality Sleep
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Post Herpetic Neuralgia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Presyncope
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Radiculopathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Reflexes Abnormal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Restless Legs Syndrome
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    4
    2
    1
    Sciatica
         subjects affected / exposed
    11 / 542 (2.03%)
    1 / 93 (1.08%)
    10 / 540 (1.85%)
         occurrences all number
    13
    2
    14
    Sensory Disturbance
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Sinus Headache
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    8
    0
    1
    Somnolence
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences all number
    4
    1
    5
    Speech Disorder Developmental
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal Cord Compression
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    3
    0
    3
    Syncope
         subjects affected / exposed
    9 / 542 (1.66%)
    3 / 93 (3.23%)
    7 / 540 (1.30%)
         occurrences all number
    9
    3
    7
    Syncope Vasovagal
         subjects affected / exposed
    5 / 542 (0.92%)
    2 / 93 (2.15%)
    2 / 540 (0.37%)
         occurrences all number
    5
    2
    2
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    10 / 542 (1.85%)
    3 / 93 (3.23%)
    6 / 540 (1.11%)
         occurrences all number
    11
    3
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    59 / 542 (10.89%)
    12 / 93 (12.90%)
    53 / 540 (9.81%)
         occurrences all number
    112
    17
    84
    Anaemia of Malignant Disease
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Haemorrhagic Anaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Iron Deficiency Anaemia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Haemorrhagic Diathesis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Leukocytosis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Leukopenia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    9
    0
    7
    Lymphatic Obstruction
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    4 / 542 (0.74%)
    3 / 93 (3.23%)
    5 / 540 (0.93%)
         occurrences all number
    4
    3
    9
    Neutropenia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    5
    0
    5
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Pernicious Anaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Splenic Granuloma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Thrombocythaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    10 / 542 (1.85%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    26
    0
    13
    Ear and labyrinth disorders
    Cerumen Impaction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Conductive Deafness
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Deafness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Ear Congestion
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Ear Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Ear Pain
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    11
    0
    1
    Eustachian Tube Dysfunction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hearing Impaired
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Hyperacusis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hypoacusis
         subjects affected / exposed
    11 / 542 (2.03%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    11
    0
    8
    Middle Ear Effusion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Tinnitus
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    8 / 540 (1.48%)
         occurrences all number
    4
    0
    8
    Tympanic Membrane Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Tympanic Membrane Perforation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Vertigo
         subjects affected / exposed
    17 / 542 (3.14%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    22
    1
    5
    Eye disorders
    Abnormal Sensation in Eye
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Asthenopia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Astigmatism
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Blepharitis
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    2
    1
    0
    Blepharospasm
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blindness Transient
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Blindness Unilateral
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Borderline Glaucoma
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cataract
         subjects affected / exposed
    13 / 542 (2.40%)
    4 / 93 (4.30%)
    12 / 540 (2.22%)
         occurrences all number
    18
    5
    14
    Conjunctival Haemorrhage
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Conjunctivitis
         subjects affected / exposed
    7 / 542 (1.29%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    8
    1
    3
    Conjunctivitis Allergic
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Corneal Deposits
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Diplopia
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    7
    0
    3
    Dry Eye
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    4
    0
    4
    Episcleritis
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema of Eyelid
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Exophthalmos
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Eye Discharge
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Eye Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Eye Haemorrhage
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    3
    1
    2
    Eye Inflammation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Eye Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    3 / 93 (3.23%)
    3 / 540 (0.56%)
         occurrences all number
    3
    3
    3
    Eye Swelling
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelid Irritation
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Eyelid Oedema
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelid Ptosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Glaucoma
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Keratoconjunctivitis Sicca
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Lacrimation Increased
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    7
    0
    3
    Macular Degeneration
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Mydriasis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Ocular Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Ocular Hyperaemia
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    4
    1
    6
    Ocular Icterus
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Ocular Surface Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Orbital Oedema
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Panophthalmitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Photopsia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Retinal Artery Occlusion
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Retinal Detachment
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal Vein Thrombosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Vision Blurred
         subjects affected / exposed
    11 / 542 (2.03%)
    0 / 93 (0.00%)
    9 / 540 (1.67%)
         occurrences all number
    11
    0
    9
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    1
    0
    3
    Visual Disturbance
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    4
    0
    4
    Vitreous Floaters
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    12 / 542 (2.21%)
    0 / 93 (0.00%)
    9 / 540 (1.67%)
         occurrences all number
    14
    0
    9
    Abdominal Distension
         subjects affected / exposed
    15 / 542 (2.77%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    15
    1
    12
    Abdominal Hernia
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Abdominal Mass
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal Pain
         subjects affected / exposed
    49 / 542 (9.04%)
    5 / 93 (5.38%)
    44 / 540 (8.15%)
         occurrences all number
    66
    7
    57
    Abdominal Pain Lower
         subjects affected / exposed
    13 / 542 (2.40%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    16
    0
    8
    Abdominal Pain Upper
         subjects affected / exposed
    19 / 542 (3.51%)
    0 / 93 (0.00%)
    20 / 540 (3.70%)
         occurrences all number
    21
    0
    24
    Abdominal Tenderness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Abdominal Wall Mass
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Anal Fistula
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Anal Haemorrhage
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Anal Pruritus
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Anorectal Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    2
    0
    3
    Ascites
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Barrett's Oesophagus
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bowel Movement Irregularity
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Breath Odour
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Change of Bowel Habit
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cheilitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    1
    0
    3
    Colitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    4
    Colitis Ischaemic
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Colonic Polyp
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    2
    1
    1
    Constipation
         subjects affected / exposed
    144 / 542 (26.57%)
    15 / 93 (16.13%)
    112 / 540 (20.74%)
         occurrences all number
    204
    16
    140
    Defaecation Urgency
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    7
    0
    1
    Dental Caries
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    6
    0
    0
    Dental Discomfort
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    135 / 542 (24.91%)
    13 / 93 (13.98%)
    98 / 540 (18.15%)
         occurrences all number
    203
    16
    142
    Diverticulum
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Diverticulum Intestinal
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    3
    1
    0
    Dry Mouth
         subjects affected / exposed
    20 / 542 (3.69%)
    2 / 93 (2.15%)
    16 / 540 (2.96%)
         occurrences all number
    26
    2
    16
    Duodenal Ulcer
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    62 / 542 (11.44%)
    1 / 93 (1.08%)
    28 / 540 (5.19%)
         occurrences all number
    78
    1
    29
    Dysphagia
         subjects affected / exposed
    5 / 542 (0.92%)
    2 / 93 (2.15%)
    11 / 540 (2.04%)
         occurrences all number
    5
    2
    14
    Enteritis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Enterovesical Fistula
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Epigastric Discomfort
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    0
    1
    3
    Eructation
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    3
    Faecal Incontinence
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    2
    Faeces Discoloured
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Flatulence
         subjects affected / exposed
    23 / 542 (4.24%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    25
    1
    12
    Food Poisoning
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    2
    1
    2
    Frequent Bowel Movements
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Gastric Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric Ulcer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    8 / 542 (1.48%)
    2 / 93 (2.15%)
    5 / 540 (0.93%)
         occurrences all number
    8
    2
    5
    Gastritis Atrophic
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Gastritis Haemorrhagic
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal Angiodysplasia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal Motility Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    27 / 542 (4.98%)
    1 / 93 (1.08%)
    24 / 540 (4.44%)
         occurrences all number
    33
    1
    26
    Gingival Pain
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    3
    1
    1
    Gingivitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Glossodynia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Haematemesis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    7 / 540 (1.30%)
         occurrences all number
    9
    2
    7
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Haemorrhoids
         subjects affected / exposed
    9 / 542 (1.66%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    12
    1
    7
    Hiatus Hernia
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    2
    1
    1
    Hypoaesthesia Oral
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Ileus
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Inflammatory Bowel Disease
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Inguinal Hernia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Intestinal Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Intra-Abdominal Haematoma
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Lip Dry
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Lip Swelling
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Lip Ulceration
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Loose Tooth
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Malocclusion
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Melaena
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Mesenteric Vein Thrombosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    2
    Nausea
         subjects affected / exposed
    144 / 542 (26.57%)
    15 / 93 (16.13%)
    127 / 540 (23.52%)
         occurrences all number
    210
    17
    155
    Odynophagia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Oedema Mouth
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Oesophagitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Oral Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Oral Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Oral Pruritus
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Oroantral Fistula
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Painful Defaecation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pancreatic Cyst
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic Insufficiency
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia Oral
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Peptic Ulcer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Periodontal Disease
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Peritonitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pigmentation Buccal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Proctalgia
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    7
    0
    2
    Proctitis
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    1
    1
    1
    Rectal Haemorrhage
         subjects affected / exposed
    21 / 542 (3.87%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    24
    1
    12
    Rectal Polyp
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal Spasm
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Reflux Oesophagitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Retching
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Salivary Hypersecretion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Sensitivity of Teeth
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Small Intestinal Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Stomach Discomfort
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    7
    0
    7
    Stomatitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Tongue Black Hairy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Tongue Coated
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Tongue Ulceration
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Tooth Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    1
    1
    0
    Toothache
         subjects affected / exposed
    15 / 542 (2.77%)
    2 / 93 (2.15%)
    11 / 540 (2.04%)
         occurrences all number
    18
    2
    13
    Vomiting
         subjects affected / exposed
    86 / 542 (15.87%)
    12 / 93 (12.90%)
    61 / 540 (11.30%)
         occurrences all number
    115
    14
    76
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Hepatomegaly
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    0
    1
    1
    Hepatotoxicity
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    13 / 542 (2.40%)
    1 / 93 (1.08%)
    8 / 540 (1.48%)
         occurrences all number
    26
    1
    13
    Jaundice
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Jaundice Cholestatic
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Actinic Keratosis
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    10
    0
    12
    Alopecia
         subjects affected / exposed
    13 / 542 (2.40%)
    2 / 93 (2.15%)
    9 / 540 (1.67%)
         occurrences all number
    14
    2
    9
    Angioedema
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Blister
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Blood Blister
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Campbell De Morgan Spots
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cold Sweat
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Decubitus Ulcer
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    0
    1
    1
    Dermal Cyst
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    6
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    0
    0
    4
    Dermatitis Acneiform
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Dermatitis Allergic
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Dermatitis Contact
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Dry Skin
         subjects affected / exposed
    12 / 542 (2.21%)
    4 / 93 (4.30%)
    13 / 540 (2.41%)
         occurrences all number
    13
    4
    18
    Ecchymosis
         subjects affected / exposed
    25 / 542 (4.61%)
    1 / 93 (1.08%)
    19 / 540 (3.52%)
         occurrences all number
    32
    1
    26
    Eczema
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    4
    0
    3
    Erythema
         subjects affected / exposed
    16 / 542 (2.95%)
    2 / 93 (2.15%)
    9 / 540 (1.67%)
         occurrences all number
    17
    3
    9
    Facial Wasting
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Haemorrhage Subcutaneous
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hair Growth Abnormal
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Hyperhidrosis
         subjects affected / exposed
    20 / 542 (3.69%)
    0 / 93 (0.00%)
    21 / 540 (3.89%)
         occurrences all number
    26
    0
    27
    Hyperkeratosis
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    5
    2
    1
    Hypertrichosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia Facial
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Increased Tendency to Bruise
         subjects affected / exposed
    22 / 542 (4.06%)
    0 / 93 (0.00%)
    14 / 540 (2.59%)
         occurrences all number
    23
    0
    16
    Ingrowing Nail
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Keloid Scar
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Lentigo
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Lipohypertrophy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Livedo Reticularis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Nail Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Neurodermatitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    2
    Night Sweats
         subjects affected / exposed
    13 / 542 (2.40%)
    2 / 93 (2.15%)
    10 / 540 (1.85%)
         occurrences all number
    14
    3
    13
    Onychalgia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Onychoclasis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Onychomadesis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Pain of Skin
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Palmar-Plantar Erythrodysaesthesia Syndrome
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    2
    Periorbital Oedema
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    3
    Petechiae
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    5
    0
    4
    Photosensitivity Reaction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Pigmentation Disorder
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Pityriasis Rosea
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Precancerous Skin Lesion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    17 / 542 (3.14%)
    0 / 93 (0.00%)
    10 / 540 (1.85%)
         occurrences all number
    19
    0
    11
    Pruritus Generalised
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Psoriasis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Purpura
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    4 / 540 (0.74%)
         occurrences all number
    6
    1
    5
    Purpura Senile
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    49 / 542 (9.04%)
    1 / 93 (1.08%)
    21 / 540 (3.89%)
         occurrences all number
    64
    1
    22
    Rash Erythematous
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Rash Follicular
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Rash Macular
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Rash Maculo-Papular
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Rash Papular
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Rash Pruritic
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Rash Vesicular
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Rosacea
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Scab
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    7
    0
    1
    Scar
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    1
    1
    0
    Seborrhoeic Dermatitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Atrophy
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    9 / 540 (1.67%)
         occurrences all number
    7
    0
    10
    Skin Discolouration
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    6
    0
    2
    Skin Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Skin Exfoliation
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Skin Fragility
         subjects affected / exposed
    2 / 542 (0.37%)
    2 / 93 (2.15%)
    1 / 540 (0.19%)
         occurrences all number
    2
    2
    1
    Skin Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Skin Induration
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Skin Inflammation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Irritation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Skin Lesion
         subjects affected / exposed
    15 / 542 (2.77%)
    2 / 93 (2.15%)
    5 / 540 (0.93%)
         occurrences all number
    18
    2
    6
    Skin Mass
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Nodule
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Skin Striae
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Skin Toxicity
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Ulcer
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    7
    0
    1
    Stasis Dermatitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Swelling Face
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Telangiectasia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    3
    0
    4
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Azotaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Bladder Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Bladder Disorder
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Bladder Obstruction
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bladder Hypertrophy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bladder Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bladder Stenosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bladder Spasm
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    4
    1
    1
    Calculus Bladder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Calculus Ureteric
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Calculus Urethral
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Chromaturia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Cystitis Noninfective
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Enuresis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    3
    0
    3
    Dysuria
         subjects affected / exposed
    21 / 542 (3.87%)
    1 / 93 (1.08%)
    21 / 540 (3.89%)
         occurrences all number
    26
    1
    26
    Glycosuria
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Haematuria
         subjects affected / exposed
    56 / 542 (10.33%)
    4 / 93 (4.30%)
    32 / 540 (5.93%)
         occurrences all number
    89
    4
    40
    Haemorrhage Urinary Tract
         subjects affected / exposed
    11 / 542 (2.03%)
    0 / 93 (0.00%)
    6 / 540 (1.11%)
         occurrences all number
    14
    0
    6
    Hydronephrosis
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    15 / 540 (2.78%)
         occurrences all number
    8
    2
    17
    Hydroureter
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Kidney Enlargement
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Leukocyturia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Micturition Urgency
         subjects affected / exposed
    11 / 542 (2.03%)
    1 / 93 (1.08%)
    12 / 540 (2.22%)
         occurrences all number
    12
    1
    12
    Nephrolithiasis
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    6
    0
    3
    Nocturia
         subjects affected / exposed
    38 / 542 (7.01%)
    0 / 93 (0.00%)
    29 / 540 (5.37%)
         occurrences all number
    45
    0
    34
    Obstructive Uropathy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Oliguria
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Pollakiuria
         subjects affected / exposed
    56 / 542 (10.33%)
    2 / 93 (2.15%)
    55 / 540 (10.19%)
         occurrences all number
    85
    2
    70
    Polyuria
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    4
    1
    3
    Proteinuria
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Pyelocaliectasis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Renal Colic
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Renal Failure
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    3
    1
    3
    Renal Failure Acute
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    4
    0
    5
    Renal Failure Chronic
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Renal Impairment
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    3
    Renal Mass
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Renal Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Stress Urinary Incontinence
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    3
    1
    2
    Ureteric Obstruction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    2
    0
    3
    Ureteric Stenosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urethral Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urethral Obstruction
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Urethral Pain
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    6
    1
    5
    Urethral Stenosis
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    4
    0
    0
    Urge Incontinence
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary Bladder Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary Hesitation
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    3
    1
    0
    Urinary Incontinence
         subjects affected / exposed
    37 / 542 (6.83%)
    0 / 93 (0.00%)
    25 / 540 (4.63%)
         occurrences all number
    49
    0
    37
    Urinary Retention
         subjects affected / exposed
    18 / 542 (3.32%)
    1 / 93 (1.08%)
    14 / 540 (2.59%)
         occurrences all number
    24
    1
    16
    Urinary Tract Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Urinary Tract Inflammation
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary Tract Obstruction
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    8
    0
    1
    Urinary Tract Pain
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urine Abnormality
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Urine Flow Decreased
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    8 / 540 (1.48%)
         occurrences all number
    8
    0
    8
    Urine Odour Abnormal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Urogenital Haemorrhage
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Cushing's Syndrome
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Cushingoid
         subjects affected / exposed
    7 / 542 (1.29%)
    1 / 93 (1.08%)
    12 / 540 (2.22%)
         occurrences all number
    8
    1
    13
    Feminisation Acquired
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Gynaecomastia
         subjects affected / exposed
    14 / 542 (2.58%)
    3 / 93 (3.23%)
    21 / 540 (3.89%)
         occurrences all number
    14
    3
    24
    Hyperparathyroidism
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperparathyroidism Primary
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Hypoparathyroidism
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoparathyroidism Secondary
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Hypothyroidism
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Pituitary-Dependent Cushing's Syndrome
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Primary Hyperaldosteronism
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Steroid Withdrawal Syndrome
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Amyotrophy
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Arthralgia
         subjects affected / exposed
    172 / 542 (31.73%)
    19 / 93 (20.43%)
    131 / 540 (24.26%)
         occurrences all number
    302
    29
    195
    Arthritis
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    2
    Arthropathy
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Back Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Back Pain
         subjects affected / exposed
    199 / 542 (36.72%)
    26 / 93 (27.96%)
    180 / 540 (33.33%)
         occurrences all number
    359
    39
    311
    Bone Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Bone Pain
         subjects affected / exposed
    144 / 542 (26.57%)
    14 / 93 (15.05%)
    112 / 540 (20.74%)
         occurrences all number
    229
    16
    159
    Bone Swelling
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bunion
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bursitis
         subjects affected / exposed
    4 / 542 (0.74%)
    2 / 93 (2.15%)
    7 / 540 (1.30%)
         occurrences all number
    5
    2
    7
    Coccydynia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    5 / 540 (0.93%)
         occurrences all number
    2
    0
    5
    Dupuytren's Contracture
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Exostosis
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    1
    1
    0
    Flank Pain
         subjects affected / exposed
    27 / 542 (4.98%)
    1 / 93 (1.08%)
    16 / 540 (2.96%)
         occurrences all number
    30
    1
    21
    Foot Deformity
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Groin Pain
         subjects affected / exposed
    41 / 542 (7.56%)
    0 / 93 (0.00%)
    22 / 540 (4.07%)
         occurrences all number
    52
    0
    33
    Intervertebral Disc Compression
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Intervertebral Disc Protrusion
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Joint Range of Motion Decreased
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Joint Stiffness
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Joint Swelling
         subjects affected / exposed
    7 / 542 (1.29%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    7
    0
    3
    Limb Discomfort
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    7 / 540 (1.30%)
         occurrences all number
    2
    0
    7
    Low Turnover Osteopathy
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Mobility Decreased
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    6
    0
    1
    Muscle Atrophy
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    5
    0
    2
    Muscle Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle Mass
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Muscle Spasms
         subjects affected / exposed
    78 / 542 (14.39%)
    2 / 93 (2.15%)
    111 / 540 (20.56%)
         occurrences all number
    107
    2
    173
    Muscle Twitching
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    1
    0
    3
    Muscular Weakness
         subjects affected / exposed
    35 / 542 (6.46%)
    5 / 93 (5.38%)
    42 / 540 (7.78%)
         occurrences all number
    55
    6
    52
    Musculoskeletal Chest Pain
         subjects affected / exposed
    22 / 542 (4.06%)
    4 / 93 (4.30%)
    26 / 540 (4.81%)
         occurrences all number
    25
    4
    26
    Musculoskeletal Discomfort
         subjects affected / exposed
    12 / 542 (2.21%)
    1 / 93 (1.08%)
    13 / 540 (2.41%)
         occurrences all number
    13
    1
    13
    Musculoskeletal Disorder
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    97 / 542 (17.90%)
    12 / 93 (12.90%)
    77 / 540 (14.26%)
         occurrences all number
    144
    13
    106
    Musculoskeletal Stiffness
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    6 / 540 (1.11%)
         occurrences all number
    11
    0
    6
    Myalgia
         subjects affected / exposed
    40 / 542 (7.38%)
    3 / 93 (3.23%)
    32 / 540 (5.93%)
         occurrences all number
    48
    3
    39
    Myopathy
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    2
    2
    8
    Myopathy Steroid
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    2
    Myosclerosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Myositis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Neck Mass
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Neck Pain
         subjects affected / exposed
    30 / 542 (5.54%)
    2 / 93 (2.15%)
    17 / 540 (3.15%)
         occurrences all number
    41
    2
    20
    Nodule on Extremity
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Osteitis
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Osteoarthritis
         subjects affected / exposed
    7 / 542 (1.29%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    10
    1
    6
    Osteonecrosis
         subjects affected / exposed
    8 / 542 (1.48%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    11
    3
    5
    Osteopenia
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    5
    0
    4
    Osteoporosis
         subjects affected / exposed
    12 / 542 (2.21%)
    3 / 93 (3.23%)
    7 / 540 (1.30%)
         occurrences all number
    13
    4
    7
    Osteoporotic Fracture
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in Extremity
         subjects affected / exposed
    107 / 542 (19.74%)
    16 / 93 (17.20%)
    89 / 540 (16.48%)
         occurrences all number
    172
    20
    127
    Pain in Jaw
         subjects affected / exposed
    15 / 542 (2.77%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    23
    1
    7
    Pathological Fracture
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Periarthritis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Polyarthritis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Pubic Pain
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Rotator Cuff Syndrome
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Sensation of Heaviness
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Soft Tissue Disorder
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal Column Stenosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Synovial Cyst
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    4
    0
    2
    Tendon Pain
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Tendonitis
         subjects affected / exposed
    1 / 542 (0.18%)
    2 / 93 (2.15%)
    2 / 540 (0.37%)
         occurrences all number
    1
    2
    2
    Torticollis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Trigger Finger
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Upper Extremity Mass
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Vertebral Column Mass
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal Wall Abscess
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Abscess Jaw
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Abscess Limb
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    0
    1
    1
    Abscess Oral
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Acute Sinusitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Anal Abscess
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Arthritis Bacterial
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Arthritis Infective
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bacterial Sepsis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bacteriuria
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    34 / 542 (6.27%)
    0 / 93 (0.00%)
    14 / 540 (2.59%)
         occurrences all number
    39
    0
    16
    Bronchitis Bacterial
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Bronchitis Viral
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchopulmonary Aspergillosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Campylobacter Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Campylobacter Intestinal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Candidiasis
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    6
    0
    3
    Catheter Related Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Catheter Site Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    16 / 542 (2.95%)
    4 / 93 (4.30%)
    8 / 540 (1.48%)
         occurrences all number
    18
    7
    8
    Chest Wall Abscess
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Clostridial Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Clostridium Difficile Colitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Cystitis
         subjects affected / exposed
    8 / 542 (1.48%)
    2 / 93 (2.15%)
    5 / 540 (0.93%)
         occurrences all number
    12
    2
    6
    Diverticulitis
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    9
    0
    4
    Ear Infection
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    10
    0
    0
    Endocarditis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    External Ear Cellulitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Eye Infection
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    5
    1
    2
    Eyelid Infection
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Febrile Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    3
    Folliculitis
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    5
    0
    4
    Fungal Infection
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    4
    0
    3
    Fungal Oesophagitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal Skin Infection
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    2
    0
    3
    Furuncle
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Gastroenteritis
         subjects affected / exposed
    9 / 542 (1.66%)
    1 / 93 (1.08%)
    9 / 540 (1.67%)
         occurrences all number
    9
    1
    9
    Gastroenteritis Norovirus
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis Viral
         subjects affected / exposed
    9 / 542 (1.66%)
    3 / 93 (3.23%)
    3 / 540 (0.56%)
         occurrences all number
    9
    4
    3
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival Abscess
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Gingival Infection
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    3
    0
    2
    Groin Abscess
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatitis C
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes Simplex
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Herpes Virus Infection
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Herpes Zoster
         subjects affected / exposed
    10 / 542 (1.85%)
    2 / 93 (2.15%)
    8 / 540 (1.48%)
         occurrences all number
    11
    2
    9
    Hordeolum
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Infected Cyst
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Infected Skin Ulcer
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Influenza
         subjects affected / exposed
    25 / 542 (4.61%)
    3 / 93 (3.23%)
    15 / 540 (2.78%)
         occurrences all number
    35
    3
    16
    Labyrinthitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Laryngitis
         subjects affected / exposed
    4 / 542 (0.74%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    4
    0
    1
    Lobar Pneumonia
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    3
    0
    1
    Localised Infection
         subjects affected / exposed
    5 / 542 (0.92%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    5
    1
    5
    Lower Respiratory Tract Infection
         subjects affected / exposed
    12 / 542 (2.21%)
    5 / 93 (5.38%)
    13 / 540 (2.41%)
         occurrences all number
    17
    8
    16
    Lower Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Lung Infection
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    3
    0
    3
    Nail Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    65 / 542 (11.99%)
    5 / 93 (5.38%)
    46 / 540 (8.52%)
         occurrences all number
    94
    8
    59
    Oesophageal Candidiasis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Onychomycosis
         subjects affected / exposed
    8 / 542 (1.48%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    8
    0
    1
    Oral Candidiasis
         subjects affected / exposed
    12 / 542 (2.21%)
    2 / 93 (2.15%)
    10 / 540 (1.85%)
         occurrences all number
    13
    3
    10
    Oral Fungal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Oral Herpes
         subjects affected / exposed
    10 / 542 (1.85%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    13
    1
    5
    Oral Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Osteomyelitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Otitis Externa
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Otitis Media
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Paronychia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Parotitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pertussis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    5
    0
    4
    Pharyngitis Streptococcal
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    7
    1
    8
    Pneumonia Klebsiella
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Prostatic Abscess
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Proteus Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Pyelonephritis
         subjects affected / exposed
    1 / 542 (0.18%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    1
    1
    0
    Rash Pustular
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    2
    Respiratory Tract Infection
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    6
    1
    5
    Rhinitis
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    2
    1
    3
    Rotavirus Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Salmonellosis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Sepsis
         subjects affected / exposed
    3 / 542 (0.55%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    3
    0
    0
    Septic Shock
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    29 / 542 (5.35%)
    3 / 93 (3.23%)
    5 / 540 (0.93%)
         occurrences all number
    43
    3
    5
    Skin Candida
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Infection
         subjects affected / exposed
    7 / 542 (1.29%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    8
    1
    1
    Soft Tissue Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal Infection
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal Sepsis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Streptococcal Infection
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Subcutaneous Abscess
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea Cruris
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Tinea Pedis
         subjects affected / exposed
    5 / 542 (0.92%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    5
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth Abscess
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    7 / 540 (1.30%)
         occurrences all number
    4
    1
    8
    Tooth Infection
         subjects affected / exposed
    13 / 542 (2.40%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    15
    1
    4
    Tracheitis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    74 / 542 (13.65%)
    4 / 93 (4.30%)
    43 / 540 (7.96%)
         occurrences all number
    108
    5
    58
    Urinary Tract Infection
         subjects affected / exposed
    49 / 542 (9.04%)
    11 / 93 (11.83%)
    40 / 540 (7.41%)
         occurrences all number
    73
    21
    61
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Urinary Tract Infection Pseudomonal
         subjects affected / exposed
    0 / 542 (0.00%)
    1 / 93 (1.08%)
    0 / 540 (0.00%)
         occurrences all number
    0
    1
    0
    Urosepsis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    2
    Viral Infection
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    2
    0
    4
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    8 / 542 (1.48%)
    1 / 93 (1.08%)
    1 / 540 (0.19%)
         occurrences all number
    8
    1
    1
    Wound Infection
         subjects affected / exposed
    4 / 542 (0.74%)
    1 / 93 (1.08%)
    2 / 540 (0.37%)
         occurrences all number
    4
    1
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    56 / 542 (10.33%)
    10 / 93 (10.75%)
    40 / 540 (7.41%)
         occurrences all number
    75
    11
    46
    Central Obesity
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Decreased Appetite
         subjects affected / exposed
    28 / 542 (5.17%)
    0 / 93 (0.00%)
    30 / 540 (5.56%)
         occurrences all number
    31
    0
    31
    Dehydration
         subjects affected / exposed
    14 / 542 (2.58%)
    4 / 93 (4.30%)
    18 / 540 (3.33%)
         occurrences all number
    17
    5
    20
    Diabetes Mellitus
         subjects affected / exposed
    12 / 542 (2.21%)
    0 / 93 (0.00%)
    8 / 540 (1.48%)
         occurrences all number
    12
    0
    8
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Dyslipidaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Failure to Thrive
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    0
    0
    3
    Fluid Retention
         subjects affected / exposed
    6 / 542 (1.11%)
    0 / 93 (0.00%)
    3 / 540 (0.56%)
         occurrences all number
    6
    0
    3
    Glucose Tolerance Impaired
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Gout
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    1
    Hyperalbuminaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    2 / 540 (0.37%)
         occurrences all number
    1
    0
    2
    Hypercalcaemia
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    6 / 540 (1.11%)
         occurrences all number
    13
    0
    6
    Hypercholesterolaemia
         subjects affected / exposed
    20 / 542 (3.69%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    21
    1
    11
    Hyperglycaemia
         subjects affected / exposed
    52 / 542 (9.59%)
    6 / 93 (6.45%)
    41 / 540 (7.59%)
         occurrences all number
    93
    7
    74
    Hyperkalaemia
         subjects affected / exposed
    12 / 542 (2.21%)
    1 / 93 (1.08%)
    11 / 540 (2.04%)
         occurrences all number
    19
    1
    14
    Hyperlipidaemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    1
    0
    1
    Hypermagnesaemia
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    14
    1
    8
    Hypernatraemia
         subjects affected / exposed
    9 / 542 (1.66%)
    0 / 93 (0.00%)
    10 / 540 (1.85%)
         occurrences all number
    20
    0
    14
    Hyperphosphataemia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    2
    0
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    8 / 542 (1.48%)
    2 / 93 (2.15%)
    5 / 540 (0.93%)
         occurrences all number
    8
    3
    6
    Hyperuricaemia
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    4
    1
    6
    Hypoalbuminaemia
         subjects affected / exposed
    5 / 542 (0.92%)
    3 / 93 (3.23%)
    5 / 540 (0.93%)
         occurrences all number
    9
    4
    11
    Hypocalcaemia
         subjects affected / exposed
    8 / 542 (1.48%)
    2 / 93 (2.15%)
    2 / 540 (0.37%)
         occurrences all number
    12
    2
    5
    Hypoglycaemia
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    4 / 540 (0.74%)
         occurrences all number
    2
    0
    5
    Hypokalaemia
         subjects affected / exposed
    99 / 542 (18.27%)
    9 / 93 (9.68%)
    68 / 540 (12.59%)
         occurrences all number
    176
    13
    107
    Hypomagnesaemia
         subjects affected / exposed
    7 / 542 (1.29%)
    2 / 93 (2.15%)
    6 / 540 (1.11%)
         occurrences all number
    8
    2
    6
    Hyponatraemia
         subjects affected / exposed
    14 / 542 (2.58%)
    5 / 93 (5.38%)
    15 / 540 (2.78%)
         occurrences all number
    31
    7
    19
    Hypophosphataemia
         subjects affected / exposed
    11 / 542 (2.03%)
    2 / 93 (2.15%)
    8 / 540 (1.48%)
         occurrences all number
    20
    2
    19
    Hypovolaemia
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Increased Appetite
         subjects affected / exposed
    10 / 542 (1.85%)
    0 / 93 (0.00%)
    11 / 540 (2.04%)
         occurrences all number
    11
    0
    11
    Malnutrition
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolic Acidosis
         subjects affected / exposed
    0 / 542 (0.00%)
    0 / 93 (0.00%)
    1 / 540 (0.19%)
         occurrences all number
    0
    0
    1
    Polydipsia
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Tetany
         subjects affected / exposed
    1 / 542 (0.18%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    1
    0
    0
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    2 / 542 (0.37%)
    0 / 93 (0.00%)
    0 / 540 (0.00%)
         occurrences all number
    2
    0
    0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    3 / 542 (0.55%)
    1 / 93 (1.08%)
    6 / 540 (1.11%)
         occurrences all number
    3
    1
    6
    Vitamin B12 Deficiency
         subjects affected / exposed
    2 / 542 (0.37%)
    1 / 93 (1.08%)
    3 / 540 (0.56%)
         occurrences all number
    2
    1
    3
    Vitamin D Deficiency
         subjects affected / exposed
    6 / 542 (1.11%)
    1 / 93 (1.08%)
    5 / 540 (0.93%)
         occurrences all number
    6
    1
    5

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2010
    Expansion of genetic analyses to include biomarkers other than TMPRSS2-ERG
    07 Jun 2011
    Inclusion of an additional interim analysis of the Overall Survival (OS) co-primary endpoint, adjustment of the timing of the interim analyses for OS and addition of a strategy to adjust for a potential cross-over effect
    02 Apr 2012
    Updated the eligibility criteria and modified the schedule of events for subjects who will cross over from placebo to abiraterone acetate after the study drug assignments were unblinded, provided information on the IDMC recommendation to unblind the treatment assignments.
    09 Jul 2012
    The main reason of this amendment was to to allow subjects who had formerly received placebo treatment but had discontinued from the protocol and who met the eligibility criteria under Amendment 4, to also receive treatment with abiraterone acetate.

    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.
    These results are up to clinical cutoff (CCO) date (that is, 31 March 2014).
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Nov 29 16:38:42 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA