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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
    Netherlands: 19
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 1331
    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
    Australia: 168
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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%)
    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
    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 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
    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
    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
    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 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
    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
    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
    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 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
    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 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
    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
    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 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 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 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
    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
    Additional description: Swelling
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    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
    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
    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 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 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 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 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 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 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 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
    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
    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
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    1
    2
    1
    Bronchiectasis
    Additional description: Bronchiectasis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    14 / 642 (2.18%)
    20 / 430 (4.65%)
    16 / 639 (2.50%)
         occurrences all number
    18
    26
    19
    Dry throat
    Additional description: Dry throat
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    29 / 642 (4.52%)
    8 / 430 (1.86%)
    41 / 639 (6.42%)
         occurrences all number
    52
    21
    71
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    24 / 642 (3.74%)
    23 / 430 (5.35%)
    31 / 639 (4.85%)
         occurrences all number
    50
    37
    42
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    8 / 642 (1.25%)
    5 / 430 (1.16%)
    16 / 639 (2.50%)
         occurrences all number
    14
    6
    26
    Lung disorder
    Additional description: Lung disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Nasal congestion
    Additional description: Nasal congestion
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    6
    0
    0
    Nasal crusting
    Additional description: Nasal crusting
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal discomfort
    Additional description: Nasal discomfort
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Nasal polyps
    Additional description: Nasal polyps
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    5
    0
    0
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    12 / 642 (1.87%)
    8 / 430 (1.86%)
    11 / 639 (1.72%)
         occurrences all number
    16
    11
    17
    Pharyngeal swelling
    Additional description: Pharyngeal swelling
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Productive cough
    Additional description: Productive cough
         subjects affected / exposed
    1 / 642 (0.16%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    1
    3
    2
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    2
    0
    Respiratory disorder
    Additional description: Respiratory disorder
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    2
    1
    0
    Rhinitis allergic
    Additional description: Rhinitis allergic
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    4
    Rhinorrhoea
    Additional description: Rhinorrhoea
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    3
    1
    2
    Sinus congestion
    Additional description: Sinus congestion
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus disorder
    Additional description: Sinus disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    2
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    3
    1
    0
    Sputum discoloured
    Additional description: Sputum discoloured
         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
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Throat irritation
    Additional description: Throat irritation
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    2
    1
    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
    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 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
    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
    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 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 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 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 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 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 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 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 creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    28 / 642 (4.36%)
    28 / 430 (6.51%)
    18 / 639 (2.82%)
         occurrences all number
    44
    49
    27
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    0
    1
    3
    Blood iron decreased
    Additional description: Blood iron decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Blood lactate dehydrogenase abnormal
    Additional description: Blood lactate dehydrogenase abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    4 / 642 (0.62%)
    4 / 430 (0.93%)
    3 / 639 (0.47%)
         occurrences all number
    5
    5
    5
    Blood phosphorus abnormal
    Additional description: Blood phosphorus abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Blood phosphorus decreased
    Additional description: Blood phosphorus decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    4 / 639 (0.63%)
         occurrences all number
    0
    1
    4
    Blood potassium increased
    Additional description: Blood potassium increased
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    8 / 639 (1.25%)
         occurrences all number
    0
    4
    10
    Blood test abnormal
    Additional description: Blood test abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Blood testosterone decreased
    Additional description: Blood testosterone decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Blood triglycerides abnormal
    Additional description: Blood triglycerides abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urea abnormal
    Additional description: Blood urea abnormal
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    2
    8
    2
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    2 / 642 (0.31%)
    7 / 430 (1.63%)
    3 / 639 (0.47%)
         occurrences all number
    2
    10
    5
    Blood uric acid increased
    Additional description: Blood uric acid increased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Blood urine present
    Additional description: Blood urine present
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Colonoscopy
    Additional description: Colonoscopy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Full blood count abnormal
    Additional description: Full blood count abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyltransferase abnormal
    Additional description: Gamma-glutamyltransferase abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    3 / 639 (0.47%)
         occurrences all number
    2
    3
    3
    Gastric pH increased
    Additional description: Gastric pH increased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    2
    1
    Globulins increased
    Additional description: Globulins increased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Glomerular filtration rate decreased
    Additional description: Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    3
    0
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    4 / 642 (0.62%)
    4 / 430 (0.93%)
    6 / 639 (0.94%)
         occurrences all number
    8
    5
    8
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Lipase increased
    Additional description: Lipase increased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Liver function test increased
    Additional description: Liver function test increased
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Liver function test abnormal
    Additional description: Liver function test abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    2
    Monocyte count increased
    Additional description: Monocyte count increased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count decreased
    Additional description: Neutrophil count decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Platelet analyses
    Additional description: Platelet analyses
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    5
    1
    4
    Prostatic specific antigen abnormal
    Additional description: Prostatic specific antigen abnormal
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Prostatic specific antigen increased
    Additional description: Prostatic specific antigen increased
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    5
    4
    0
    Red blood cell count decreased
    Additional description: Red blood cell count decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Rheumatoid factor
    Additional description: Rheumatoid factor
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    3
    Vitamin D decreased
    Additional description: Vitamin D decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    11 / 642 (1.71%)
    3 / 430 (0.70%)
    7 / 639 (1.10%)
         occurrences all number
    15
    3
    9
    Weight increased
    Additional description: Weight increased
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    6
    1
    2
    White blood cell count decreased
    Additional description: White blood cell count decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    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
    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
    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
    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
    Cardiac disorders
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    11
    1
    1
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences all number
    2
    4
    3
    Atrioventricular block
    Additional description: Atrioventricular block
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Atrioventricular block second degree
    Additional description: Atrioventricular block second degree
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cardiac disorder
    Additional description: Cardiac disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cardiac valve disease
    Additional description: Cardiac valve disease
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Myocardial infarction
    Additional description: Myocardial infarction
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    0
    0
    3
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    3 / 642 (0.47%)
    5 / 430 (1.16%)
    0 / 639 (0.00%)
         occurrences all number
    3
    5
    0
    Nervous system disorders
    Ageusia
    Additional description: Ageusia
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    0
    5
    1
    Amnesia
    Additional description: Amnesia
         subjects affected / exposed
    1 / 642 (0.16%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    1
    4
    1
    Anosmia
    Additional description: Anosmia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Aphasia
    Additional description: Aphasia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Balance disorder
    Additional description: Balance disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Burning sensation
    Additional description: Burning sensation
         subjects affected / exposed
    1 / 642 (0.16%)
    4 / 430 (0.93%)
    1 / 639 (0.16%)
         occurrences all number
    1
    6
    1
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    0
    5
    1
    Cluster headache
    Additional description: Cluster headache
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cognitive and attention disorders and disturbances NEC
    Additional description: Cognitive and attention disorders and disturbances NEC
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    4
    0
    Diabetic neuropathy
    Additional description: Diabetic neuropathy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    7
    0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    15 / 642 (2.34%)
    21 / 430 (4.88%)
    8 / 639 (1.25%)
         occurrences all number
    20
    25
    11
    Dizziness postural
    Additional description: Dizziness postural
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Dysaesthesia
    Additional description: Dysaesthesia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    3
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    4 / 642 (0.62%)
    2 / 430 (0.47%)
    7 / 639 (1.10%)
         occurrences all number
    4
    6
    8
    Facial paralysis
    Additional description: Facial paralysis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Head discomfort
    Additional description: Head discomfort
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    50 / 642 (7.79%)
    35 / 430 (8.14%)
    55 / 639 (8.61%)
         occurrences all number
    73
    58
    68
    Hydrocephalus
    Additional description: Hydrocephalus
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperaesthesia
    Additional description: Hyperaesthesia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    4
    0
    Lethargy
    Additional description: Lethargy
         subjects affected / exposed
    4 / 642 (0.62%)
    0 / 430 (0.00%)
    4 / 639 (0.63%)
         occurrences all number
    4
    0
    7
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    1
    3
    1
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    3
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    5 / 642 (0.78%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    5
    2
    2
    Nervous system disorder
    Additional description: Nervous system disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Neuralgia
    Additional description: Neuralgia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    0
    2
    5
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    7 / 642 (1.09%)
    4 / 430 (0.93%)
    10 / 639 (1.56%)
         occurrences all number
    8
    4
    10
    Neurotoxicity
    Additional description: Neurotoxicity
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences all number
    4
    1
    3
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    18 / 642 (2.80%)
    14 / 430 (3.26%)
    18 / 639 (2.82%)
         occurrences all number
    23
    29
    29
    Parkinson's disease
    Additional description: Parkinson's disease
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral motor neuropathy
    Additional description: Peripheral motor neuropathy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    1
    2
    0
    Poor quality sleep
    Additional description: Poor quality sleep
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Psychomotor hyperactivity
    Additional description: Psychomotor hyperactivity
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Resting tremor
    Additional description: Resting tremor
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Restless legs syndrome
    Additional description: Restless legs syndrome
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    4 / 642 (0.62%)
    3 / 430 (0.70%)
    4 / 639 (0.63%)
         occurrences all number
    4
    11
    7
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Sensory neuropathy
    Additional description: Sensory neuropathy
         subjects affected / exposed
    4 / 642 (0.62%)
    2 / 430 (0.47%)
    8 / 639 (1.25%)
         occurrences all number
    9
    10
    14
    Sinus headache
    Additional description: Sinus headache
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    1
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    4 / 639 (0.63%)
         occurrences all number
    3
    2
    4
    Taste disorder
    Additional description: Taste disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    5 / 430 (1.16%)
    5 / 639 (0.78%)
         occurrences all number
    1
    9
    7
    Transient global amnesia
    Additional description: Transient global amnesia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    2
    0
    2
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    5
    0
    0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    7 / 642 (1.09%)
    8 / 430 (1.86%)
    5 / 639 (0.78%)
         occurrences all number
    9
    8
    7
    Leukopenia
    Additional description: Leukopenia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    0 / 639 (0.00%)
         occurrences all number
    4
    5
    0
    Platelet disorder
    Additional description: Platelet disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences all number
    1
    1
    3
    Thrombocytosis
    Additional description: Thrombocytosis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Deafness
    Additional description: Deafness
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    3
    0
    5
    Ear congestion
    Additional description: Ear congestion
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    0
    0
    3
    Eustachian tube dysfunction
    Additional description: Eustachian tube dysfunction
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    5
    0
    2
    Hypoacusis
    Additional description: Hypoacusis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    1 / 642 (0.16%)
    6 / 430 (1.40%)
    8 / 639 (1.25%)
         occurrences all number
    2
    13
    12
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Amaurosis fugax
    Additional description: Amaurosis fugax
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Astigmatism
    Additional description: Astigmatism
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Blindness
    Additional description: Blindness
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Chalazion
    Additional description: Chalazion
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    1 / 642 (0.16%)
    3 / 430 (0.70%)
    3 / 639 (0.47%)
         occurrences all number
    4
    3
    4
    Eye haemorrhage
    Additional description: Eye haemorrhage
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Eye irritation
    Additional description: Eye irritation
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    2
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Eye pruritus
    Additional description: Eye pruritus
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Eye swelling
    Additional description: Eye swelling
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Eyelid cyst
    Additional description: Eyelid cyst
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid irritation
    Additional description: Eyelid irritation
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid oedema
    Additional description: Eyelid oedema
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Foreign body sensation in eyes
    Additional description: Foreign body sensation in eyes
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Glaucoma
    Additional description: Glaucoma
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Iritis
    Additional description: Iritis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    2
    Keratitis
    Additional description: Keratitis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Ocular hyperaemia
    Additional description: Ocular hyperaemia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Periorbital swelling
    Additional description: Periorbital swelling
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Periorbital oedema
    Additional description: Periorbital oedema
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Retinal detachment
    Additional description: Retinal detachment
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal haemorrhage
    Additional description: Retinal haemorrhage
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal vein occlusion
    Additional description: Retinal vein occlusion
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    13
    1
    0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences all number
    2
    6
    3
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    6 / 642 (0.93%)
    4 / 430 (0.93%)
    4 / 639 (0.63%)
         occurrences all number
    6
    4
    4
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    9 / 642 (1.40%)
    8 / 430 (1.86%)
    6 / 639 (0.94%)
         occurrences all number
    10
    14
    6
    Abdominal hernia
    Additional description: Abdominal hernia
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    6
    0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    39 / 642 (6.07%)
    32 / 430 (7.44%)
    53 / 639 (8.29%)
         occurrences all number
    49
    50
    85
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    2 / 642 (0.31%)
    5 / 430 (1.16%)
    4 / 639 (0.63%)
         occurrences all number
    2
    8
    5
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    20 / 642 (3.12%)
    10 / 430 (2.33%)
    22 / 639 (3.44%)
         occurrences all number
    27
    12
    31
    Abdominal tenderness
    Additional description: Abdominal tenderness
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Abnormal faeces
    Additional description: Abnormal faeces
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Anal fissure
    Additional description: Anal fissure
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Anal haemorrhage
    Additional description: Anal haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Anal inflammation
    Additional description: Anal inflammation
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    3
    0
    0
    Anal pruritus
    Additional description: Anal pruritus
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Change of bowel habit
    Additional description: Change of bowel habit
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    3
    1
    0
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    64 / 642 (9.97%)
    28 / 430 (6.51%)
    57 / 639 (8.92%)
         occurrences all number
    95
    53
    86
    Defaecation urgency
    Additional description: Defaecation urgency
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Dental caries
    Additional description: Dental caries
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    379 / 642 (59.03%)
    134 / 430 (31.16%)
    391 / 639 (61.19%)
         occurrences all number
    1054
    307
    1644
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    5 / 642 (0.78%)
    8 / 430 (1.86%)
    2 / 639 (0.31%)
         occurrences all number
    6
    9
    2
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    23 / 642 (3.58%)
    19 / 430 (4.42%)
    19 / 639 (2.97%)
         occurrences all number
    31
    43
    35
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    4 / 639 (0.63%)
         occurrences all number
    1
    1
    5
    Epigastric discomfort
    Additional description: Epigastric discomfort
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    0
    1
    2
    Faecaloma
    Additional description: Faecaloma
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Faeces discoloured
    Additional description: Faeces discoloured
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    6 / 642 (0.93%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences all number
    7
    3
    6
    Food poisoning
    Additional description: Food poisoning
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Frequent bowel movements
    Additional description: Frequent bowel movements
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    2
    1
    0
    Gastric ulcer
    Additional description: Gastric ulcer
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    0
    3
    1
    Gastrointestinal disorder
    Additional description: Gastrointestinal disorder
         subjects affected / exposed
    6 / 642 (0.93%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    6
    0
    1
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    6 / 642 (0.93%)
    1 / 430 (0.23%)
    7 / 639 (1.10%)
         occurrences all number
    7
    1
    7
    Gastrointestinal mucocoele
    Additional description: Gastrointestinal mucocoele
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal obstruction
    Additional description: Gastrointestinal obstruction
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Gastrointestinal pain
    Additional description: Gastrointestinal pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    8 / 642 (1.25%)
    3 / 430 (0.70%)
    8 / 639 (1.25%)
         occurrences all number
    9
    5
    11
    Gingival bleeding
    Additional description: Gingival bleeding
         subjects affected / exposed
    7 / 642 (1.09%)
    2 / 430 (0.47%)
    6 / 639 (0.94%)
         occurrences all number
    7
    3
    6
    Gingival pain
    Additional description: Gingival pain
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Gingival ulceration
    Additional description: Gingival ulceration
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Glossitis
    Additional description: Glossitis
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Glossodynia
    Additional description: Glossodynia
         subjects affected / exposed
    11 / 642 (1.71%)
    0 / 430 (0.00%)
    10 / 639 (1.56%)
         occurrences all number
    23
    0
    16
    Haematemesis
    Additional description: Haematemesis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    0 / 642 (0.00%)
    5 / 430 (1.16%)
    1 / 639 (0.16%)
         occurrences all number
    0
    6
    1
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    5 / 642 (0.78%)
    1 / 430 (0.23%)
    6 / 639 (0.94%)
         occurrences all number
    6
    1
    8
    Hhaemorrhoids
    Additional description: Hhaemorrhoids
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Hypoaesthesia oral
    Additional description: Hypoaesthesia oral
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    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 all number
    1
    0
    0
    Lip swelling
    Additional description: Lip swelling
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Lower gastrointestinal haemorrhage
    Additional description: Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Mouth haemorrhage
    Additional description: Mouth haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    0
    1
    2
    Mouth ulceration
    Additional description: Mouth ulceration
         subjects affected / exposed
    12 / 642 (1.87%)
    6 / 430 (1.40%)
    12 / 639 (1.88%)
         occurrences all number
    13
    9
    12
    Mucous stools
    Additional description: Mucous stools
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    211 / 642 (32.87%)
    111 / 430 (25.81%)
    186 / 639 (29.11%)
         occurrences all number
    385
    264
    390
    Oesophagitis
    Additional description: Oesophagitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Oral discomfort
    Additional description: Oral discomfort
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Oral pain
    Additional description: Oral pain
         subjects affected / exposed
    21 / 642 (3.27%)
    9 / 430 (2.09%)
    30 / 639 (4.69%)
         occurrences all number
    27
    13
    40
    Pancreatic insufficiency
    Additional description: Pancreatic insufficiency
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    4
    0
    1
    Pancreatitis acute
    Additional description: Pancreatitis acute
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Paraesthesia oral
    Additional description: Paraesthesia oral
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Proctalgia
    Additional description: Proctalgia
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    4
    0
    2
    Proctitis
    Additional description: Proctitis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    3 / 642 (0.47%)
    4 / 430 (0.93%)
    6 / 639 (0.94%)
         occurrences all number
    3
    5
    8
    Salivary gland disorder
    Additional description: Salivary gland disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Salivary gland enlargement
    Additional description: Salivary gland enlargement
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    60 / 642 (9.35%)
    17 / 430 (3.95%)
    63 / 639 (9.86%)
         occurrences all number
    92
    32
    105
    Swollen tongue
    Additional description: Swollen tongue
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Tongue discolouration
    Additional description: Tongue discolouration
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Tongue ulceration
    Additional description: Tongue ulceration
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    2
    1
    1
    Tongue dry
    Additional description: Tongue dry
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth disorder
    Additional description: Tooth disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    4 / 639 (0.63%)
         occurrences all number
    4
    2
    9
    Umbilical hernia
    Additional description: Umbilical hernia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    26 / 642 (4.05%)
    10 / 430 (2.33%)
    26 / 639 (4.07%)
         occurrences all number
    32
    12
    39
    Hepatobiliary disorders
    Biliary colic
    Additional description: Biliary colic
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    1
    1
    3
    Hepatitis cholestatic
    Additional description: Hepatitis cholestatic
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatocellular injury
    Additional description: Hepatocellular injury
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperbilirubinaemia
    Additional description: Hyperbilirubinaemia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
    Additional description: Acne
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    338 / 642 (52.65%)
    53 / 430 (12.33%)
    304 / 639 (47.57%)
         occurrences all number
    703
    112
    787
    Angioedema
    Additional description: Angioedema
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Blister
    Additional description: Blister
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    4
    1
    2
    Blood blister
    Additional description: Blood blister
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    2
    Dandruff
    Additional description: Dandruff
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    1
    Dermatitis contact
    Additional description: Dermatitis contact
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis exfoliative generalised
    Additional description: Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    46 / 642 (7.17%)
    25 / 430 (5.81%)
    39 / 639 (6.10%)
         occurrences all number
    71
    55
    70
    Dyshidrotic eczema
    Additional description: Dyshidrotic eczema
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    2
    1
    0
    Eczema asteatotic
    Additional description: Eczema asteatotic
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    18 / 642 (2.80%)
    5 / 430 (1.16%)
    12 / 639 (1.88%)
         occurrences all number
    23
    5
    17
    Furuncle
    Additional description: Furuncle
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Haemorrhage subcutaneous
    Additional description: Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Hair colour changes
    Additional description: Hair colour changes
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    2
    0
    4
    Hair growth abnormal
    Additional description: Hair growth abnormal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Hair texture abnormal
    Additional description: Hair texture abnormal
         subjects affected / exposed
    5 / 642 (0.78%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences all number
    5
    1
    6
    Hand and foot syndrome
    Additional description: Hand and foot syndrome
         subjects affected / exposed
    491 / 642 (76.48%)
    135 / 430 (31.40%)
    473 / 639 (74.02%)
         occurrences all number
    1566
    338
    1910
    Hidradenitis
    Additional description: Hidradenitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    4 / 642 (0.62%)
    2 / 430 (0.47%)
    6 / 639 (0.94%)
         occurrences all number
    4
    3
    10
    Hyperkeratosis
    Additional description: Hyperkeratosis
         subjects affected / exposed
    7 / 642 (1.09%)
    1 / 430 (0.23%)
    10 / 639 (1.56%)
         occurrences all number
    9
    3
    17
    Miliaria
    Additional description: Miliaria
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Mucocutaneous rash
    Additional description: Mucocutaneous rash
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Nail disorder
    Additional description: Nail disorder
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    3 / 639 (0.47%)
         occurrences all number
    3
    5
    4
    Nail pitting
    Additional description: Nail pitting
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Nail psoriasis
    Additional description: Nail psoriasis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Nail ridging
    Additional description: Nail ridging
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Neurodermatitis
    Additional description: Neurodermatitis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Night sweats
    Additional description: Night sweats
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    3
    2
    1
    Onychalgia
    Additional description: Onychalgia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Onychoclasis
    Additional description: Onychoclasis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    12
    0
    Pain of skin
    Additional description: Pain of skin
         subjects affected / exposed
    23 / 642 (3.58%)
    6 / 430 (1.40%)
    27 / 639 (4.23%)
         occurrences all number
    33
    25
    34
    Palmar-plantar erythrodysaesthesia syndrome
    Additional description: Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    4
    0
    Photosensitivity reaction
    Additional description: Photosensitivity reaction
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    2
    0
    5
    Pigmentation disorder
    Additional description: Pigmentation disorder
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Plantar erythema
    Additional description: Plantar erythema
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Pruritis
    Additional description: Pruritis
         subjects affected / exposed
    25 / 642 (3.89%)
    9 / 430 (2.09%)
    28 / 639 (4.38%)
         occurrences all number
    33
    9
    43
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    48 / 642 (7.48%)
    25 / 430 (5.81%)
    64 / 639 (10.02%)
         occurrences all number
    68
    34
    93
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    8 / 642 (1.25%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    12
    1
    11
    Rash
    Additional description: Rash
         subjects affected / exposed
    439 / 642 (68.38%)
    130 / 430 (30.23%)
    437 / 639 (68.39%)
         occurrences all number
    1110
    305
    1174
    Rash papular
    Additional description: Rash papular
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    6 / 639 (0.94%)
         occurrences all number
    3
    4
    9
    Scar pain
    Additional description: Scar pain
         subjects affected / exposed
    12 / 642 (1.87%)
    21 / 430 (4.88%)
    13 / 639 (2.03%)
         occurrences all number
    13
    34
    16
    Skin atrophy
    Additional description: Skin atrophy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Skin depigmentation
    Additional description: Skin depigmentation
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Skin discolouration
    Additional description: Skin discolouration
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Skin disorder
    Additional description: Skin disorder
         subjects affected / exposed
    2 / 642 (0.31%)
    3 / 430 (0.70%)
    5 / 639 (0.78%)
         occurrences all number
    2
    3
    5
    Skin exfoliation
    Additional description: Skin exfoliation
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Skin fissures
    Additional description: Skin fissures
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Skin hypertrophy
    Additional description: Skin hypertrophy
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Skin irritation
    Additional description: Skin irritation
         subjects affected / exposed
    4 / 642 (0.62%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    7
    0
    1
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    4 / 639 (0.63%)
         occurrences all number
    6
    1
    5
    Skin mass
    Additional description: Skin mass
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    1
    1
    2
    Skin papilloma
    Additional description: Skin papilloma
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Skin reaction
    Additional description: Skin reaction
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Skin swelling
    Additional description: Skin swelling
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Skin tightness
    Additional description: Skin tightness
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    2
    Skin toxicity
    Additional description: Skin toxicity
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    2
    Splinter haemorrhages
    Additional description: Splinter haemorrhages
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Toxic skin eruption
    Additional description: Toxic skin eruption
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    1
    Renal and urinary disorders
    Bladder pain
    Additional description: Bladder pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Chromaturia
    Additional description: Chromaturia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    0
    4
    3
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    3 / 642 (0.47%)
    3 / 430 (0.70%)
    4 / 639 (0.63%)
         occurrences all number
    3
    7
    5
    Hypertonic bladder
    Additional description: Hypertonic bladder
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Lower urinary tract symptoms
    Additional description: Lower urinary tract symptoms
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Micturition urgency
    Additional description: Micturition urgency
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    5
    1
    2
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    5 / 642 (0.78%)
    6 / 430 (1.40%)
    3 / 639 (0.47%)
         occurrences all number
    7
    18
    3
    Pollakiuria
    Additional description: Pollakiuria
         subjects affected / exposed
    4 / 642 (0.62%)
    5 / 430 (1.16%)
    3 / 639 (0.47%)
         occurrences all number
    5
    9
    3
    Polyuria
    Additional description: Polyuria
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Proteinuria
    Additional description: Proteinuria
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    1
    2
    2
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    3
    0
    Renal pain
    Additional description: Renal pain
         subjects affected / exposed
    1 / 642 (0.16%)
    4 / 430 (0.93%)
    2 / 639 (0.31%)
         occurrences all number
    1
    5
    2
    Renal vein occlusion
    Additional description: Renal vein occlusion
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Testicular pain
    Additional description: Testicular pain
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Urethral haemorrhage
    Additional description: Urethral haemorrhage
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Urethral stenosis
    Additional description: Urethral stenosis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract disorder
    Additional description: Urinary tract disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Urine abnormality
    Additional description: Urine abnormality
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hyperparathyroidism
    Additional description: Hyperparathyroidism
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    3
    0
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    2
    0
    Hypogonadism
    Additional description: Hypogonadism
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    2
    0
    4
    Parathyroid disorder
    Additional description: Parathyroid disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroid mass
    Additional description: Thyroid mass
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Thyroid disorder
    Additional description: Thyroid disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroiditis
    Additional description: Thyroiditis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    48 / 642 (7.48%)
    57 / 430 (13.26%)
    48 / 639 (7.51%)
         occurrences all number
    69
    100
    65
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    5 / 642 (0.78%)
    8 / 430 (1.86%)
    5 / 639 (0.78%)
         occurrences all number
    5
    13
    5
    Arthropathy
    Additional description: Arthropathy
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    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
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    44 / 642 (6.85%)
    72 / 430 (16.74%)
    44 / 639 (6.89%)
         occurrences all number
    69
    125
    74
    Bone pain
    Additional description: Bone pain
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Fibromyalgia
    Additional description: Fibromyalgia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Fistula
    Additional description: Fistula
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Flank pain
    Additional description: Flank pain
         subjects affected / exposed
    6 / 642 (0.93%)
    12 / 430 (2.79%)
    8 / 639 (1.25%)
         occurrences all number
    8
    17
    12
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    6 / 642 (0.93%)
    7 / 430 (1.63%)
    3 / 639 (0.47%)
         occurrences all number
    7
    11
    3
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Joint stiffness
    Additional description: Joint stiffness
         subjects affected / exposed
    3 / 642 (0.47%)
    6 / 430 (1.40%)
    3 / 639 (0.47%)
         occurrences all number
    7
    9
    6
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    8 / 642 (1.25%)
    4 / 430 (0.93%)
    2 / 639 (0.31%)
         occurrences all number
    8
    4
    2
    Ligament pain
    Additional description: Ligament pain
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Limb discomfort
    Additional description: Limb discomfort
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    0
    2
    1
    Limb mass
    Additional description: Limb mass
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Mobility decreased
    Additional description: Mobility decreased
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    25 / 642 (3.89%)
    10 / 430 (2.33%)
    35 / 639 (5.48%)
         occurrences all number
    38
    17
    59
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    4 / 642 (0.62%)
    2 / 430 (0.47%)
    4 / 639 (0.63%)
         occurrences all number
    4
    2
    4
    Musculoskeletal discomfort
    Additional description: Musculoskeletal discomfort
         subjects affected / exposed
    2 / 642 (0.31%)
    4 / 430 (0.93%)
    2 / 639 (0.31%)
         occurrences all number
    2
    4
    2
    Musculoskeletal disorder
    Additional description: Musculoskeletal disorder
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    4 / 642 (0.62%)
    4 / 430 (0.93%)
    0 / 639 (0.00%)
         occurrences all number
    4
    4
    0
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    2
    2
    2
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    19 / 642 (2.96%)
    10 / 430 (2.33%)
    16 / 639 (2.50%)
         occurrences all number
    24
    13
    18
    Myositis
    Additional description: Myositis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    2
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    2 / 642 (0.31%)
    5 / 430 (1.16%)
    6 / 639 (0.94%)
         occurrences all number
    2
    5
    7
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    27 / 642 (4.21%)
    21 / 430 (4.88%)
    24 / 639 (3.76%)
         occurrences all number
    33
    27
    33
    Pain in jaw
    Additional description: Pain in jaw
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    1
    Pain of skin
    Additional description: Pain of skin
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Periarthritis
    Additional description: Periarthritis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    2
    1
    Plantar fasciitis
    Additional description: Plantar fasciitis
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    1
    3
    1
    Polyarthritis
    Additional description: Polyarthritis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Polymyalgia rheumatica
    Additional description: Polymyalgia rheumatica
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    3
    0
    0
    Rheumatoid arthritis
    Additional description: Rheumatoid arthritis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Synovial cyst
    Additional description: Synovial cyst
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Tendon pain
    Additional description: Tendon pain
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Tendonitis
    Additional description: Tendonitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    1
    0
    1
    Tenosynovitis
    Additional description: Tenosynovitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Trigger finger
    Additional description: Trigger finger
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences all number
    1
    1
    4
    Anal abscess
    Additional description: Anal abscess
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    0
    0
    6
    Balanitis candida
    Additional description: Balanitis candida
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Bronchiolitis
    Additional description: Bronchiolitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Candida infection
    Additional description: Candida infection
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    1
    2
    1
    Cardiac infection
    Additional description: Cardiac infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    5 / 642 (0.78%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    6
    0
    3
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    2
    1
    0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    3 / 642 (0.47%)
    5 / 430 (1.16%)
    0 / 639 (0.00%)
         occurrences all number
    3
    5
    0
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    0
    1
    1
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    3
    0
    3
    Ear infection fungal
    Additional description: Ear infection fungal
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Epididymitis
    Additional description: Epididymitis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    2
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Folliculitis
    Additional description: Folliculitis
         subjects affected / exposed
    11 / 642 (1.71%)
    1 / 430 (0.23%)
    6 / 639 (0.94%)
         occurrences all number
    15
    1
    8
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    0
    0
    2
    Furuncle
    Additional description: Furuncle
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    7 / 639 (1.10%)
         occurrences all number
    4
    1
    9
    Gastric infection
    Additional description: Gastric infection
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    3 / 642 (0.47%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    3
    0
    0
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Genital candidiasis
    Additional description: Genital candidiasis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Gingivitis
    Additional description: Gingivitis
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    4
    1
    1
    Groin abscess
    Additional description: Groin abscess
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Groin infection
    Additional description: Groin infection
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Helicobacter infection
    Additional description: Helicobacter infection
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Herpes virus infection
    Additional description: Herpes virus infection
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    3
    2
    0
    Hordeolum
    Additional description: Hordeolum
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Infection
    Additional description: Infection
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    4 / 639 (0.63%)
         occurrences all number
    0
    3
    4
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    3 / 642 (0.47%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    3
    2
    0
    Labyrinthitis
    Additional description: Labyrinthitis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    2 / 639 (0.31%)
         occurrences all number
    1
    2
    2
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    9 / 642 (1.40%)
    13 / 430 (3.02%)
    17 / 639 (2.66%)
         occurrences all number
    11
    15
    17
    Nail infection
    Additional description: Nail infection
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    8 / 642 (1.25%)
    11 / 430 (2.56%)
    7 / 639 (1.10%)
         occurrences all number
    9
    13
    7
    Onychomycosis
    Additional description: Onychomycosis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    1
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    3
    0
    0
    Periodontitis
    Additional description: Periodontitis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    0 / 642 (0.00%)
    2 / 430 (0.47%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Pustule
    Additional description: Pustule
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    3 / 639 (0.47%)
         occurrences all number
    2
    1
    5
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    3
    1
    2
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    2
    1
    5
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    4
    1
    2
    Skin infection
    Additional description: Skin infection
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    1
    Subcutaneous abscess
    Additional description: Subcutaneous abscess
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Tetanus
    Additional description: Tetanus
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Tinea pedis
    Additional description: Tinea pedis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis
    Additional description: Tonsillitis
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    4 / 642 (0.62%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    4
    1
    2
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    2
    1
    2
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    9 / 642 (1.40%)
    6 / 430 (1.40%)
    4 / 639 (0.63%)
         occurrences all number
    9
    7
    4
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    14 / 642 (2.18%)
    12 / 430 (2.79%)
    5 / 639 (0.78%)
         occurrences all number
    18
    20
    5
    Vaginal infection
    Additional description: Vaginal infection
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    3 / 639 (0.47%)
         occurrences all number
    1
    0
    3
    Vulvovaginal candidiasis
    Additional description: Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Vulvovaginitis
    Additional description: Vulvovaginitis
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    2
    0
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    2
    0
    1
    Metabolism and nutrition disorders
    Cell death
    Additional description: Cell death
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    2 / 639 (0.31%)
         occurrences all number
    1
    0
    2
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    42 / 642 (6.54%)
    8 / 430 (1.86%)
    44 / 639 (6.89%)
         occurrences all number
    61
    10
    65
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    2 / 642 (0.31%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    2
    2
    1
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    1 / 642 (0.16%)
    2 / 430 (0.47%)
    1 / 639 (0.16%)
         occurrences all number
    1
    2
    1
    Diabetes mellitus (incl subtypes)
    Additional description: Diabetes mellitus (incl subtypes)
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetes mellitus inadequate control
    Additional description: Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Fluid retention
    Additional description: Fluid retention
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    1
    1
    0
    Gout
    Additional description: Gout
         subjects affected / exposed
    5 / 642 (0.78%)
    4 / 430 (0.93%)
    6 / 639 (0.94%)
         occurrences all number
    6
    4
    13
    Hypercalcaemia
    Additional description: Hypercalcaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    0
    5
    1
    Hypercholesterolaemia
    Additional description: Hypercholesterolaemia
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    4
    9
    0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    1 / 642 (0.16%)
    3 / 430 (0.70%)
    1 / 639 (0.16%)
         occurrences all number
    1
    5
    4
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    1 / 642 (0.16%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    1
    1
    2
    Hyperlipidaemia
    Additional description: Hyperlipidaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    3
    Hypertriglyceridaemia
    Additional description: Hypertriglyceridaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    1 / 430 (0.23%)
    0 / 639 (0.00%)
         occurrences all number
    0
    1
    0
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    0 / 642 (0.00%)
    0 / 430 (0.00%)
    1 / 639 (0.16%)
         occurrences all number
    0
    0
    1
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    3 / 642 (0.47%)
    1 / 430 (0.23%)
    1 / 639 (0.16%)
         occurrences all number
    3
    1
    1
    Hypophosphataemia
    Additional description: Hypophosphataemia
         subjects affected / exposed
    2 / 642 (0.31%)
    1 / 430 (0.23%)
    2 / 639 (0.31%)
         occurrences all number
    5
    1
    4
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 642 (0.31%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    2
    0
    0
    Vitamin B12 deficiency
    Additional description: Vitamin B12 deficiency
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0
    Vitamin D deficiency
    Additional description: Vitamin D deficiency
         subjects affected / exposed
    1 / 642 (0.16%)
    0 / 430 (0.00%)
    0 / 639 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jul 2017
    Based on the external results and the fact that SORCE was the only trial investigating longer duration of therapy, the following change to the SORCE analysis plan were proposed and approved. The decision to change the analysis plan was made without knowledge of the SORCE data; none of the SORCE TMG members, other than the primary trial statistician, were aware of any developing outcome data, nor were any members of the TSC. These two committees – without the primary trial statistician – made the decision to alter the main aims of the trial. SORCE's new aims were to answer the following questions: (i) Does up to three years of treatment with sorafenib increase DFS compared with placebo: a comparison of Arm C vs Arm A? (ii) If the answer to question (i) is yes, does up to one year of sorafenib (Arm B) increase DFS compared to placebo (Arm A)?

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33052759
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