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    Clinical Trial Results:
    A Phase III Randomised Double-blind Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse

    Summary
    EudraCT number
    2006-006079-19
    Trial protocol
    GB   DK   BE   FR   ES  
    Global end of trial date
    10 Mar 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Mar 2021
    First version publication date
    19 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RE05
    Additional study identifiers
    ISRCTN number
    ISRCTN38934710
    US NCT number
    NCT00492258
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical Research Council
    Sponsor organisation address
    58 Victoria Embankment, London, United Kingdom, EC4Y 0DS
    Public contact
    Angela Meade, MRC Clinical Trials Unit at UCL, a.meade@ucl.ac.uk
    Scientific contact
    Angela Meade, MRC Clinical Trials Unit at UCL, a.meade@ucl.ac.uk
    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
    13 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The standard treatment for patients with a kidney cancer which has not spread to other organs is to remove all or part of the diseased kidney (nephrectomy). The standard policy after this is watchful waiting. This means no treatment, but having regular checks so that if the cancer does come back it is caught early. The principal research question is whether sorafenib increases disease free survival (DFS) i.e reduces the risk of kidney cancer returning.
    Protection of trial subjects
    Not applicable.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jul 2007
    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
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 1331
    Country: Number of subjects enrolled
    Australia: 168
    Country: Number of subjects enrolled
    Belgium: 36
    Country: Number of subjects enrolled
    Denmark: 20
    Country: Number of subjects enrolled
    France: 122
    Country: Number of subjects enrolled
    Netherlands: 19
    Worldwide total number of subjects
    1711
    EEA total number of subjects
    1543
    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)
    1195
    From 65 to 84 years
    515
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    1711
    Number of subjects completed
    1711

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    -
    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
    Oral administration twice daily, matching active drug.

    Arm title
    1 Year Sorafenib + 2 Placebo
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Sorafenib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400mg oral administration twice daily. Dose reductions were permitted in the event of significant toxicity. Subsequent re-escalation was allowed but not mandatory.

    Arm title
    3 Years Sorafenib
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Sorafenib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg oral tablet, twice daily. Dose reductions were permitted in the event of significant toxicity. Subsequent re-escalation was allowed but not mandatory

    Number of subjects in period 1
    Placebo 1 Year Sorafenib + 2 Placebo 3 Years Sorafenib
    Started
    430
    642
    639
    Completed
    430
    642
    639

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    1 Year Sorafenib + 2 Placebo
    Reporting group description
    -

    Reporting group title
    3 Years Sorafenib
    Reporting group description
    -

    Reporting group values
    Placebo 1 Year Sorafenib + 2 Placebo 3 Years Sorafenib Total
    Number of subjects
    430 642 639 1711
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    301 440 454 1195
        From 65-84 years
    129 201 185 515
        85 years and over
    0 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.4 ± 10.3 58.3 ± 10.6 58.0 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    124 190 181 495
        Male
    306 452 458 1216
    Country
    Units: Subjects
        Australia
    42 62 64 168
        Belgium
    11 12 13 36
        Denmark
    5 8 7 20
        France
    32 45 45 122
        Netherlands
    5 8 6 19
        Spain
    4 6 5 15
        United Kingdom
    331 501 499 1331
    WHO Status
    Units: Subjects
        Zero
    345 517 501 1363
        One
    83 121 131 335
        Two
    0 0 1 1
        Not recorded
    2 4 6 12
    Histology
    Units: Subjects
        Clear Cell
    361 534 550 1445
        Papillary
    33 58 37 128
        Chromophobe
    29 31 36 96
        Collecting Duct
    1 2 1 4
        Other
    6 17 15 38
    Pathological T cat. of Primary Tumour
    Units: Subjects
        pT1a
    3 2 2 7
        pT1b
    44 82 71 197
        pT2
    103 154 143 400
        pT3a-4
    280 404 423 1107
    Regional Lymph Node Status
    Units: Subjects
        pNx/pN0
    412 619 606 1637
        pN1/pN2
    18 23 33 74
    Tumour Size
    Units: Subjects
        <10
    286 436 430 1152
        >10
    144 206 209 559
    Nuclear Grade
    Units: Subjects
        One
    19 38 32 89
        Two
    105 159 176 440
        Three
    222 323 314 859
        Four
    84 122 116 322
        Not recorded
    0 0 1 1
    Histological Tumour Necrosis
    Units: Subjects
        No
    192 284 298 774
        Yes
    238 358 341 937
    Leibovich Score Group
    Units: Subjects
        Intermediate
    224 342 344 910
        High
    206 300 295 801
    Time from renal cell carcinoma diagnosis to randomisation
    Units: days
        arithmetic mean (full range (min-max))
    84 (11 to 201) 82.2 (-320 to 268) 83.2 (7 to 344) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    1 Year Sorafenib + 2 Placebo
    Reporting group description
    -

    Reporting group title
    3 Years Sorafenib
    Reporting group description
    -

    Primary: Disease free survival (DFS)

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    End point title
    Disease free survival (DFS)
    End point description
    End point type
    Primary
    End point timeframe
    DFS is the interval from randomisation to first evidence of local recurrence or distant metastases or death from RCC; if a trial participant hasn't experienced an event, their last time seen on trial is used.
    End point values
    Placebo 1 Year Sorafenib + 2 Placebo 3 Years Sorafenib
    Number of subjects analysed
    430
    642
    639
    Units: years
        median (inter-quartile range (Q1-Q3))
    5.97 (1.82 to 7.64)
    5.95 (2.26 to 7.66)
    5.72 (2.11 to 7.23)
    Attachments
    Kaplan-Meier; 1 Y Sor + 2 Y Plac vs Plac
    Kaplan-Meier; 3 Y Sor vs Plac
    Statistical analysis title
    DFS 3 Years Sorafenib vs Placebo; HR
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.946
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.83
         upper limit
    1.23
    Statistical analysis title
    DFS 3 Years Sorafenib vs Placebo; RMST
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.988
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.49
         upper limit
    0.48
    Statistical analysis title
    DFS 1 Year Sor + 2 Plac vs Plac; HR
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.509
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    1.14
    Statistical analysis title
    DFS 1 Year Sor + 2 Plac vs Plac; RMST
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.422
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    0.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.27
         upper limit
    0.65

    Secondary: Metastasis free survival (MFS)

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    End point title
    Metastasis free survival (MFS)
    End point description
    End point type
    Secondary
    End point timeframe
    MFS is the interval from randomisation to first evidence of metastases or death from RCC; if a participant has not observed an event, their last time seen on trial is used.
    End point values
    Placebo 1 Year Sorafenib + 2 Placebo 3 Years Sorafenib
    Number of subjects analysed
    430
    642
    639
    Units: years
        median (inter-quartile range (Q1-Q3))
    5.98 (1.93 to 7.60)
    5.97 (2.45 to 7.70)
    5.80 (2.25 to 7.23)
    Attachments
    Kaplan Meier Curves; MFS 3 Y Sor vs Plac
    Kaplan Meier Curves; MFS 1 Y Sor + 2Y Plac vs Plac
    Statistical analysis title
    MFS 3 Year Sorafenib vs Placebo; HR
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.975
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    1.22
    Statistical analysis title
    MFS 3 Years Sorafenib vs Placebo; RMST
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.969
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.43
         upper limit
    0.45
    Statistical analysis title
    MFS 1 Y Sor + 2 Y Placebo vs Placebo; HR
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.313
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    1.1
    Statistical analysis title
    MFS 1 Y Sor + 2 Y Plac vs Placebo; RMST
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.273
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Log hazard ratio
    Point estimate
    0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.21
         upper limit
    0.74

    Secondary: Renal Cell Carcinoma survival (RCCS)

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    End point title
    Renal Cell Carcinoma survival (RCCS)
    End point description
    End point type
    Secondary
    End point timeframe
    RCCS is the time from randomisation to death from RCC; if trial participants haven't experienced this event, their last time seen on trial is used.
    End point values
    Placebo 1 Year Sorafenib + 2 Placebo 3 Years Sorafenib
    Number of subjects analysed
    430
    642
    639
    Units: years
        median (inter-quartile range (Q1-Q3))
    6.59 (4.90 to 8.03)
    6.67 (4.94 to 8.02)
    6.26 (4.68 to 7.98)
    Attachments
    Kaplan Meier Curves; 3 Y Sor Vs Plac
    Kaplan Meier Curves; 1 Y Sor + 2 Y Plac Vs Plac
    Statistical analysis title
    RCCS 3 Year Sorafenib vs Placebo; HR
    Comparison groups
    Placebo v 3 Years Sorafenib
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.421
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    1.5
    Statistical analysis title
    RCCS 3 Years Sorafenib vs Placebo; RMST
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.423
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.47
         upper limit
    0.2
    Statistical analysis title
    RCCS 1 Y Sor + 2 Y Plac vs Plac; HR
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.524
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    1.22
    Statistical analysis title
    RCCS 1 Y Sor + 2 Y Plac vs Plac; RSMT
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.439
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    0.46

    Secondary: Overall survival (OS)

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    End point title
    Overall survival (OS)
    End point description
    End point type
    Secondary
    End point timeframe
    OS is the time from randomisation to death from any cause, including RCC; if trial participants haven't experienced this event, their last time seen on trial is used.
    End point values
    Placebo 1 Year Sorafenib + 2 Placebo 3 Years Sorafenib
    Number of subjects analysed
    430
    642
    639
    Units: years
        median (inter-quartile range (Q1-Q3))
    6.69 (4.96 to 8.03)
    6.68 (4.99 to 8.02)
    6.29 (4.75 to 7.99)
    Attachments
    Kaplan Meier Curves; OS 3 Y Sor vs Plac
    Kaplan Meier Curves; OS 1 Y Sor + 2 Y Plac vs Plac
    Statistical analysis title
    OS 3 Year Sorafenib vs Placebo; HR
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.638
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    1.38
    Statistical analysis title
    OS 3 Year Sorafenib vs Placebo; RMST
    Comparison groups
    3 Years Sorafenib v Placebo
    Number of subjects included in analysis
    1069
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.711
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.41
         upper limit
    0.28
    Statistical analysis title
    OS 1 Y Sor + 2 Y Plac Vs Plac; HR
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.541
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    1.2
    Statistical analysis title
    OS 1 Y Sor + 2 Y Plac Vs Plac;RMST
    Comparison groups
    1 Year Sorafenib + 2 Placebo v Placebo
    Number of subjects included in analysis
    1072
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.453
    Method
    Restricted Mean Survival Tie Difference
    Parameter type
    Mean difference (final values)
    Point estimate
    0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.22
         upper limit
    0.49

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    BSor
    Reporting group description
    -

    Reporting group title
    APlc
    Reporting group description
    -

    Reporting group title
    CSor
    Reporting group description
    -

    Serious adverse events
    BSor APlc CSor
    Total subjects affected by serious adverse events
         subjects affected / exposed
    135 / 642 (21.03%)
    80 / 430 (18.60%)
    147 / 639 (23.00%)
         number of deaths (all causes)
    132
    96
    143
         number of deaths resulting from adverse events
    3
    2
    0
    Vascular disorders
    Aortic stenosis
    Additional description: Aortic stenosis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial occlusive disease
    Additional description: Arterial occlusive disease
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial spasm
    Additional description: Arterial spasm
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Peripheral ischaemia
    Additional description: Peripheral ischaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         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
    Additional description: Thrombosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
    Additional description: Cholecystectomy
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cyst drainage
    Additional description: Cyst drainage
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Additional description: Knee arthroplasty
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         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 operation
    Additional description: Skin operation
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Thyroidectomy
    Additional description: Thyroidectomy
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
    Additional description: B-cell lymphoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
    Additional description: Bowen's disease
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    0 / 639 (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
    Breast cancer in situ
    Additional description: Breast cancer in situ
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondroma
    Additional description: Chondroma
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
    Additional description: Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
    Additional description: Colon cancer
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Cutaneous T-cell lymphoma
    Additional description: Cutaneous T-cell lymphoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Gastric cancer
    Additional description: Gastric cancer
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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 stromal tumour
    Additional description: Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Hormone receptor positive breast cancer
    Additional description: Hormone receptor positive breast cancer
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
    Additional description: Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Intraductal proliferative breast lesion
    Additional description: Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Keratoacanthoma
    Additional description: Keratoacanthoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         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 adenocarcinoma
    Additional description: Lung adenocarcinoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Additional description: Lung neoplasm malignant
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mantle cell lymphoma
    Additional description: Mantle cell lymphoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Meningioma
    Additional description: Meningioma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Mesothelioma malignant
    Additional description: Mesothelioma malignant
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Neoplasm malignant
    Additional description: Neoplasm malignant
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Neuroendocrine tumour
    Additional description: Neuroendocrine tumour
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Nodal marginal zone B-cell lymphoma
    Additional description: Nodal marginal zone B-cell lymphoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Non-small cell lung cancer
    Additional description: Non-small cell lung cancer
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Oesophageal carcinoma
    Additional description: Oesophageal carcinoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Papillary cystadenoma lymphomatosum
    Additional description: Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
    Additional description: Papillary renal cell carcinoma
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
    Additional description: Papillary thyroid cancer
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (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
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    5 / 642 (0.78%)
    6 / 430 (1.40%)
    4 / 639 (0.63%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
    Additional description: Renal cancer
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Second primary malignancy
    Additional description: Second primary malignancy
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    10 / 642 (1.56%)
    1 / 430 (0.23%)
    12 / 639 (1.88%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 1
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovial sarcoma
    Additional description: Synovial sarcoma
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
    Additional description: Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Immune system disorders
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
    Additional description: Sarcoidosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    General disorders and administration site conditions
    Adverse drug reaction
    Additional description: Adverse drug reaction
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    9 / 642 (1.40%)
    6 / 430 (1.40%)
    8 / 639 (1.25%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chills
    Additional description: Chills
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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 like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
    Additional description: Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
    Additional description: Pain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suprapubic pain
    Additional description: Suprapubic pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Psychiatric disorders
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disorientation
    Additional description: Disorientation
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Substance-induced psychotic disorder
    Additional description: Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Suicide attempt
    Additional description: Suicide attempt
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Animal bite
    Additional description: Animal bite
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
    Additional description: Craniocerebral injury
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Expired product administered
    Additional description: Expired product administered
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Fall
    Additional description: Fall
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Head injury
    Additional description: Head injury
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Hip fracture
    Additional description: Hip fracture
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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 limb fracture
    Additional description: Lower limb fracture
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
    Additional description: Overdose
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
    Additional description: Subdural haematoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Traumatic fracture
    Additional description: Traumatic fracture
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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 glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest X-ray abnormal
    Additional description: Chest X-ray abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Liver function test abnormal
    Additional description: Liver function test abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic specific antigen increased
    Additional description: Prostatic specific antigen increased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriospasm coronary
    Additional description: Arteriospasm coronary
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
    Additional description: Cardiac failure congestive
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
    Additional description: Myocardial infarction
         subjects affected / exposed
    3 / 642 (0.47%)
    4 / 430 (0.93%)
    7 / 639 (1.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         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
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
    Additional description: Laryngeal oedema
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    1 / 642 (0.16%)
    4 / 430 (0.93%)
    5 / 639 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary infarction
    Additional description: Pulmonary infarction
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Pulmonary thrombosis
    Additional description: Pulmonary thrombosis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Nervous system disorders
    Aphasia
    Additional description: Aphasia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Additional description: Cerebral haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
    Additional description: Cerebral ischaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    4 / 639 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dural arteriovenous fistula
    Additional description: Dural arteriovenous fistula
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Headache
    Additional description: Headache
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (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
    Lethargy
    Additional description: Lethargy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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 sclerosis
    Additional description: Multiple sclerosis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
    Additional description: Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
    Additional description: Transient global amnesia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
    Additional description: Amaurosis fugax
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Blindness
    Additional description: Blindness
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Eye disorder
    Additional description: Eye disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Retinal vein occlusion
    Additional description: Retinal vein occlusion
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (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
    Retinal vein thrombosis
    Additional description: Retinal vein thrombosis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulcerative keratitis
    Additional description: Ulcerative keratitis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    5 / 642 (0.78%)
    6 / 430 (1.40%)
    8 / 639 (1.25%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    1 / 642 (0.16%)
    3 / 430 (0.70%)
    3 / 639 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
    Additional description: Abdominal wall haematoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Additional description: Colitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Crohn's disease
    Additional description: Crohn's disease
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Diaphragmatic hernia
    Additional description: Diaphragmatic hernia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    4 / 639 (0.63%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
    Additional description: Diverticulum
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
    Additional description: Food poisoning
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
    Additional description: Haematemesis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         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 obstruction
    Additional description: Intestinal obstruction
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Intra-abdominal fluid collection
    Additional description: Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Large intestinal obstruction
    Additional description: Large intestinal obstruction
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Additional description: Nausea
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Oesophageal pain
    Additional description: Oesophageal pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal spasm
    Additional description: Oesophageal spasm
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland disorder
    Additional description: Salivary gland disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Small intestinal obstruction
    Additional description: Small intestinal obstruction
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (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
    Swollen tongue
    Additional description: Swollen tongue
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
    Additional description: Hepatic failure
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Bladder obstruction
    Additional description: Bladder obstruction
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
    Additional description: Hydronephrosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic nephropathy
    Additional description: Ischaemic nephropathy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
    Additional description: Renal cyst
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (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
    Renal impairment
    Additional description: Renal impairment
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (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
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
    Additional description: Angioedema
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis exfoliative generalised
    Additional description: Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Erythema multiforme
    Additional description: Erythema multiforme
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Hand and foot syndrome
    Additional description: Hand and foot syndrome
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
    Additional description: Rash
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash erythematous
    Additional description: Rash erythematous
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin toxicity
    Additional description: Skin toxicity
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Myopathy
    Additional description: Myopathy
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothalamo-pituitary disorder
    Additional description: Hypothalamo-pituitary disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (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
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Infections and infestations
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
    Additional description: Anal abscess
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Appendicitis
    Additional description: Appendicitis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    0 / 639 (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
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Furuncle
    Additional description: Furuncle
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic infection
    Additional description: Hepatic infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
    Additional description: Infection
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (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
    Lymph gland infection
    Additional description: Lymph gland infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (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
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal abscess
    Additional description: Renal abscess
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (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
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (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
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         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
    BSor APlc CSor
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    625 / 642 (97.35%)
    414 / 430 (96.28%)
    610 / 639 (95.46%)
    Vascular disorders
    Aneurysm
    Additional description: Aneurysm
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Arterial occlusive disease
    Additional description: Arterial occlusive disease
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Arterial spasm
    Additional description: Arterial spasm
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Arteriosclerosis
    Additional description: Arteriosclerosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    2
    1
    1
    Embolism
    Additional description: Embolism
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Flushing
    Additional description: Flushing
         subjects affected / exposed
    15 / 642 (2.34%)
    3 / 430 (0.70%)
    11 / 639 (1.72%)
         occurrences all number
    19
    8
    14
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    6 / 642 (0.93%)
    5 / 430 (1.16%)
    6 / 639 (0.94%)
         occurrences all number
    12
    8
    9
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    377 / 642 (58.72%)
    203 / 430 (47.21%)
    394 / 639 (61.66%)
         occurrences all number
    1545
    999
    1784
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    2
    0
    Intermittent claudication
    Additional description: Intermittent claudication
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Ischaemic limb pain
    Additional description: Ischaemic limb pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Peripheral coldness
    Additional description: Peripheral coldness
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    4
    Phlebitis
    Additional description: Phlebitis
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    0
    2
    2
    Thrombosis
    Additional description: Thrombosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Surgical and medical procedures
    Appendicectomy
    Additional description: Appendicectomy
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Artificial urinary sphincter implant
    Additional description: Artificial urinary sphincter implant
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Bunion operation
    Additional description: Bunion operation
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cataract operation
    Additional description: Cataract operation
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cholecystectomy
    Additional description: Cholecystectomy
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Coronary artery bypass
    Additional description: Coronary artery bypass
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cryotherapy
    Additional description: Cryotherapy
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Elbow operation
    Additional description: Elbow operation
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric bypass
    Additional description: Gastric bypass
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Genitourinary operation
    Additional description: Genitourinary operation
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Hernia repair
    Additional description: Hernia repair
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    2
    1
    0
    Lesion excision
    Additional description: Lesion excision
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Lipoma excision
    Additional description: Lipoma excision
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Nail operation
    Additional description: Nail operation
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Steroid therapy
    Additional description: Steroid therapy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Therapy cessation
    Additional description: Therapy cessation
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    3
    2
    2
    Tooth repair
    Additional description: Tooth repair
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Breast cancer in situ
    Additional description: Breast cancer in situ
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Elastofibroma
    Additional description: Elastofibroma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Keratoacanthoma
    Additional description: Keratoacanthoma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Melanocytic naevus
    Additional description: Melanocytic naevus
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Meningioma
    Additional description: Meningioma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Papillary cystadenoma lymphomatosum
    Additional description: Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Pituitary tumour benign
    Additional description: Pituitary tumour benign
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    2
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    3
    3
    0
    Second primary malignancy
    Additional description: Second primary malignancy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Skin papilloma
    Additional description: Skin papilloma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    0
    1
    2
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    5 / 639 (0.78%)
         occurrences all number
    2
    1
    9
    Immune system disorders
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    4
    1
    1
    Sarcoidosis
    Additional description: Sarcoidosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    2
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    4
    Axillary pain
    Additional description: Axillary pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    8 / 642 (1.25%)
    11 / 430 (2.56%)
    14 / 639 (2.19%)
         occurrences all number
    8
    13
    15
    Chest discomfort
    Additional description: Chest discomfort
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences all number
    1
    6
    3
    Chills
    Additional description: Chills
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Cyst
    Additional description: Cyst
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    2
    2
    0
    Discomfort
    Additional description: Discomfort
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Facial discomfort
    Additional description: Facial discomfort
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Face oedema
    Additional description: Face oedema
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Facial pain
    Additional description: Facial pain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    460 / 642 (71.65%)
    256 / 430 (59.53%)
    452 / 639 (70.74%)
         occurrences all number
    1635
    1144
    1833
    Feeling abnormal
    Additional description: Feeling abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling hot
    Additional description: Feeling hot
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    2 / 639 (0.31%)
         occurrences all number
    0
    3
    3
    Feeling cold
    Additional description: Feeling cold
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Hernia
    Additional description: Hernia
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    0 / 639 (0.00%)
         occurrences all number
    0
    3
    0
    Hernia pain
    Additional description: Hernia pain
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    3
    2
    3
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    1
    1
    4
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    3 / 642 (0.47%)
    4 / 430 (0.93%)
    2 / 639 (0.31%)
         occurrences all number
    3
    6
    2
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    0 / 639 (0.00%)
         occurrences all number
    2
    3
    0
    Mucosal haemorrhage
    Additional description: Mucosal haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Mucosal dryness
    Additional description: Mucosal dryness
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    35 / 642 (5.45%)
    12 / 430 (2.79%)
    44 / 639 (6.89%)
         occurrences all number
    54
    15
    67
    Mucosal pain
    Additional description: Mucosal pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Mucositis
    Additional description: Mucositis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    14 / 642 (2.18%)
    8 / 430 (1.86%)
    4 / 639 (0.63%)
         occurrences all number
    19
    11
    5
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    3 / 642 (0.47%)
    3 / 430 (0.70%)
    2 / 639 (0.31%)
         occurrences all number
    3
    3
    2
    Pain
    Additional description: Pain
         subjects affected / exposed
    39 / 642 (6.07%)
    31 / 430 (7.21%)
    30 / 639 (4.69%)
         occurrences all number
    56
    50
    45
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    2
    3
    1
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    6 / 642 (0.93%)
    3 / 430 (0.70%)
    2 / 639 (0.31%)
         occurrences all number
    7
    3
    2
    Swelling
    Additional description: Swelling
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Suprapubic pain
    Additional description: Suprapubic pain
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Swelling face
    Additional description: Swelling face
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    4 / 639 (0.63%)
         occurrences all number
    3
    0
    5
    Temperature intolerance
    Additional description: Temperature intolerance
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    4
    Tenderness
    Additional description: Tenderness
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Ulcer
    Additional description: Ulcer
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Xerosis
    Additional description: Xerosis
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    1
    2
    2
    Psychiatric disorders
    Abnormal dreams
    Additional description: Abnormal dreams
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    2
    1
    Anger
    Additional description: Anger
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    7 / 642 (1.09%)
    14 / 430 (3.26%)
    8 / 639 (1.25%)
         occurrences all number
    7
    20
    9
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    2 / 642 (0.31%)
    4 / 430 (0.93%)
    9 / 639 (1.41%)
         occurrences all number
    2
    4
    11
    Depression
    Additional description: Depression
         subjects affected / exposed
    8 / 642 (1.25%)
    10 / 430 (2.33%)
    17 / 639 (2.66%)
         occurrences all number
    9
    15
    31
    Emotional disorder
    Additional description: Emotional disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Frustration tolerance decreased
    Additional description: Frustration tolerance decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    8 / 642 (1.25%)
    11 / 430 (2.56%)
    7 / 639 (1.10%)
         occurrences all number
    8
    21
    9
    Irritability
    Additional description: Irritability
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    4
    Libido decreased
    Additional description: Libido decreased
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    2
    1
    4
    Libido disorder
    Additional description: Libido disorder
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Loss of libido
    Additional description: Loss of libido
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Mood altered
    Additional description: Mood altered
         subjects affected / exposed
    7 / 642 (1.09%)
    4 / 430 (0.93%)
    9 / 639 (1.41%)
         occurrences all number
    7
    4
    9
    Mood swings
    Additional description: Mood swings
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Nightmare
    Additional description: Nightmare
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    1
    2
    0
    Personality change
    Additional description: Personality change
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Psychotic disorder
    Additional description: Psychotic disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Tearfulness
    Additional description: Tearfulness
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Amenorrhoea
    Additional description: Amenorrhoea
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Breast pain
    Additional description: Breast pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Breast mass
    Additional description: Breast mass
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Breast swelling
    Additional description: Breast swelling
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Breast tenderness
    Additional description: Breast tenderness
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    3 / 642 (0.47%)
    4 / 430 (0.93%)
    7 / 639 (1.10%)
         occurrences all number
    4
    4
    14
    Genital pain
    Additional description: Genital pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Gynaecomastia
    Additional description: Gynaecomastia
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    3
    1
    1
    Hydrocele
    Additional description: Hydrocele
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Menorrhagia
    Additional description: Menorrhagia
         subjects affected / exposed
    6 / 642 (0.93%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    9
    0
    1
    Menstruation irregular
    Additional description: Menstruation irregular
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Nipple disorder
    Additional description: Nipple disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Nipple enlargement
    Additional description: Nipple enlargement
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Nipple pain
    Additional description: Nipple pain
         subjects affected / exposed
    12 / 642 (1.87%)
    0 / 430 (0.00%)
    8 / 639 (1.25%)
         occurrences all number
    12
    0
    10
    Orchitis noninfective
    Additional description: Orchitis noninfective
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Pelvic pain
    Additional description: Pelvic pain
         subjects affected / exposed
    1 / 642 (0.16%)
    3 / 430 (0.70%)
    0 / 639 (0.00%)
         occurrences all number
    1
    3
    0
    Perineal erythema
    Additional description: Perineal erythema
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Perineal rash
    Additional description: Perineal rash
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Prostatomegaly
    Additional description: Prostatomegaly
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Scrotal pain
    Additional description: Scrotal pain
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    3
    0
    0
    Testicular mass
    Additional description: Testicular mass
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
    Additional description: Testicular pain
         subjects affected / exposed
    2 / 642 (0.31%)
    4 / 430 (0.93%)
    1 / 639 (0.16%)
         occurrences all number
    2
    5
    1
    Testicular swelling
    Additional description: Testicular swelling
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    5
    2
    0
    Vaginal discharge
    Additional description: Vaginal discharge
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    0
    1
    2
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    3
    4
    0
    Vulvovaginal inflammation
    Additional description: Vulvovaginal inflammation
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal pain
    Additional description: Vulvovaginal pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Vulvovaginal pruritus
    Additional description: Vulvovaginal pruritus
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Burn oesophageal
    Additional description: Burn oesophageal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    5
    2
    0
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    0
    0
    4
    Hernia pain
    Additional description: Hernia pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Incision site complication
    Additional description: Incision site complication
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    1
    1
    2
    Incisional hernia
    Additional description: Incisional hernia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Inflammation of wound
    Additional description: Inflammation of wound
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Joint injury
    Additional description: Joint injury
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Ligament sprain
    Additional description: Ligament sprain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Meniscus injury
    Additional description: Meniscus injury
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Nail avulsion
    Additional description: Nail avulsion
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Nail injury
    Additional description: Nail injury
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Procedural pain
    Additional description: Procedural pain
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    0 / 639 (0.00%)
         occurrences all number
    2
    3
    0
    Rib fracture
    Additional description: Rib fracture
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Skin injury
    Additional description: Skin injury
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    1
    2
    2
    Stoma complication
    Additional description: Stoma complication
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Sunburn
    Additional description: Sunburn
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    2
    1
    2
    Thermal burn
    Additional description: Thermal burn
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Tibia fracture
    Additional description: Tibia fracture
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Trauma
    Additional description: Trauma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Upper limb fracture
    Additional description: Upper limb fracture
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Wound complication
    Additional description: Wound complication
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Wrist fracture
    Additional description: Wrist fracture
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
    Additional description: Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Adjusted calcium
    Additional description: Adjusted calcium
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    16 / 642 (2.49%)
    5 / 430 (1.16%)
    19 / 639 (2.97%)
         occurrences all number
    20
    11
    27
    Alanine aminotransferase abnormal
    Additional description: Alanine aminotransferase abnormal
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    3
    3
    1
    Amylase abnormal
    Additional description: Amylase abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Amylase increased
    Additional description: Amylase increased
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    6 / 639 (0.94%)
         occurrences all number
    3
    2
    7
    Aspartate aminotransferase abnormal
    Additional description: Aspartate aminotransferase abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 642 (0.62%)
    2 / 430 (0.47%)
    5 / 639 (0.78%)
         occurrences all number
    4
    2
    5
    Biopsy
    Additional description: Biopsy
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Blood alkaline phosphatase abnormal
    Additional description: Blood alkaline phosphatase abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    2
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    2
    0
    4
    Blood cholesterol increased
    Additional description: Blood cholesterol increased
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    3
    2
    1
    Blood calcium decreased
    Additional description: Blood calcium decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    2
    Blood creatine abnormal
    Additional description: Blood creatine abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    0
    2
    2
    Blood creatine phosphokinase
    Additional description: Blood creatine phosphokinase
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatine increased
    Additional description: Blood creatine increased
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Blood creatinine abnormal
    Additional description: Blood creatinine abnormal
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences all number
    2
    5
    3
    Blood creatine phosphokinase increased
    Additional description: Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    5
    0
    1
    Blood creatinine increased
    Additional description: Blood creatinine increased