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    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

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    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

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    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

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    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

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    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

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    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)

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    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

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    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

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    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

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    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

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    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

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    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

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    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

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    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])

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    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)

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    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

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    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