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    Clinical Trial Results:
    A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study

    Summary
    EudraCT number
    		 2011-002009-31
    Trial protocol
    		 CZ   GB   ES   SK   NL   FR   IT   DE   EE   HU   LV   AT   GR   BG  
    Global end of trial date
    27 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2020
    First version publication date
    27 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MO25757
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01588184
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To provide continued bevacizumab therapy as single agent or in combination with an anti-cancer drug to patients with cancer, who were previously enrolled in a F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the Parent, P-trial) and who derived benefit from the therapy administered
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Brazil: 8
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 3
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Romania: 5
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    United Kingdom: 3
    Worldwide total number of subjects
    95
    EEA total number of subjects
    56
    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)
    68
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The number of participants enrolled over the planned recruitment period was open. 95 participants actually enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Breast Cancer
    Arm description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

    Arm title
    		 Ovarian Cancer or Peritoneal Carcinoma
    Arm description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

    Arm title
    		 Colorectal Cancer
    Arm description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

    Arm title
    		 Renal Cell Carcinoma
    Arm description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

    Arm title
    		 Non-Squamous, Non-Small Cell Lung Cancer
    Arm description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

    Arm title
    		 Glioblastoma Multiforme
    Arm description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

    Number of subjects in period 1
    		Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Started
    11
    41
    7
    6
    16
    14
    Completed
    8
    28
    5
    3
    14
    10
    Not completed
    3
    13
    2
    3
    2
    4
         Adverse event, serious fatal
    1
    -
    -
    1
    1
    1
         change in treatment
    -
    6
    2
    -
    1
    3
         Consent withdrawn by subject
    2
    4
    -
    1
    -
    -
         multiple reasons
    -
    3
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Breast Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Ovarian Cancer or Peritoneal Carcinoma
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Colorectal Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Renal Cell Carcinoma
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Non-Squamous, Non-Small Cell Lung Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Glioblastoma Multiforme
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group values
    		 Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme Total
    Number of subjects
    		 11 41 7 6 16 14 95
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 9 30 3 2 11 13 68
        From 65-84 years
    		 2 11 4 4 5 1 27
        85 years and over
    		 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.5 ( 7.3 ) 56.7 ( 11.2 ) 66.7 ( 13.9 ) 63.5 ( 9.8 ) 58.5 ( 10.5 ) 49.5 ( 10.9 ) -
    Sex: Female, Male
    Units:
        Female
    		 11 41 3 2 6 4 67
        Male
    		 0 0 4 4 10 10 28
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0
        Asian
    		 0 0 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0 0 0
        White
    		 0 0 0 0 0 0 0
        More than one race
    		 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 11 41 7 6 16 14 95

    End points

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    End points reporting groups
    Reporting group title
    Breast Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Ovarian Cancer or Peritoneal Carcinoma
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Colorectal Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Renal Cell Carcinoma
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Non-Squamous, Non-Small Cell Lung Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Glioblastoma Multiforme
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Primary: Percentage of Participants With Adverse Events

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    End point title
    		 Percentage of Participants With Adverse Events [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
    End point type
    Primary
    End point timeframe
    Baseline up to approximately 81 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics only
    End point values
    		 Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Number of subjects analysed
    11
    41
    7
    6
    16
    14
    Units: percentage of participants
        number (not applicable)
    90.9
    78.0
    71.4
    100.0
    75.0
    83.2
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 81 months
    End point values
    		 Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Number of subjects analysed
    11
    41
    7
    6
    16
    14
    Units: months
        arithmetic mean (standard deviation)
    35.31 ( 23.809 )
    24.39 ( 19.759 )
    17.98 ( 24.202 )
    9.31 ( 12.046 )
    17.14 ( 14.152 )
    11.31 ( 10.301 )
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival time is defined as the time from first dose of Bevacizumab in this E-trial to death from any cause.
    End point type
    Secondary
    End point timeframe
    Baseline up to approximately 81 months
    End point values
    		 Breast Cancer Ovarian Cancer or Peritoneal Carcinoma Colorectal Cancer Renal Cell Carcinoma Non-Squamous, Non-Small Cell Lung Cancer Glioblastoma Multiforme
    Number of subjects analysed
    11
    41
    7
    6
    16
    14
    Units: months
        arithmetic mean (standard deviation)
    38.82 ( 24.159 )
    27.35 ( 20.020 )
    20.30 ( 23.761 )
    11.98 ( 10.950 )
    18.31 ( 14.962 )
    12.99 ( 10.795 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to approximately 81 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Breast Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Colorectal Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Glioblastoma Multiforme
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Non-Squamous, Non-Small Cell Lung Cancer
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Ovarian Cancer or Peritoneal Carcinoma
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Reporting group title
    Renal Cell Carcinoma
    Reporting group description
    		 Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

    Serious adverse events
    		 Breast Cancer Colorectal Cancer Glioblastoma Multiforme Non-Squamous, Non-Small Cell Lung Cancer Ovarian Cancer or Peritoneal Carcinoma Renal Cell Carcinoma
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 7 (28.57%)
    3 / 14 (21.43%)
    5 / 16 (31.25%)
    2 / 41 (4.88%)
    3 / 6 (50.00%)
         number of deaths (all causes)
    1
    0
    1
    1
    0
    1
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    FEMUR FRACTURE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FRACTURE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    JAW FRACTURE
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    AORTIC STENOSIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CIRCULATORY COLLAPSE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERTENSIVE CRISIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    CARDIAC FAILURE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SINUS BRADYCARDIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    ISCHAEMIC STROKE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    VOMITING
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    PNEUMONITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    NEPHROTIC SYNDROME
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    APPENDICITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COMPLICATED APPENDICITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MENINGITIS BACTERIAL
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    WOUND INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Breast Cancer Colorectal Cancer Glioblastoma Multiforme Non-Squamous, Non-Small Cell Lung Cancer Ovarian Cancer or Peritoneal Carcinoma Renal Cell Carcinoma
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 11 (90.91%)
    5 / 7 (71.43%)
    14 / 14 (100.00%)
    12 / 16 (75.00%)
    31 / 41 (75.61%)
    6 / 6 (100.00%)
    Vascular disorders
    EMBOLISM VENOUS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HYPERTENSION
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    7 / 41 (17.07%)
    2 / 6 (33.33%)
         occurrences all number
    3
    0
    0
    1
    25
    5
    LYMPHOEDEMA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Surgical and medical procedures
    TOOTH EXTRACTION
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    ASTHENIA
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 7 (0.00%)
    5 / 14 (35.71%)
    3 / 16 (18.75%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    6
    5
    5
    0
    CHEST PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    3
    0
    FATIGUE
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    4 / 41 (9.76%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    1
    6
    0
    MUCOSAL INFLAMMATION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    OEDEMA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    OEDEMA PERIPHERAL
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    4 / 41 (9.76%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    3
    7
    0
    PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    PYREXIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
    1 / 16 (6.25%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    1
    2
    0
    Immune system disorders
    CONTRAST MEDIA ALLERGY
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    SEASONAL ALLERGY
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    CYSTOCELE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    ERECTILE DYSFUNCTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    UTERINE PROLAPSE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    1 / 6 (16.67%)
         occurrences all number
    5
    0
    1
    0
    2
    1
    DYSPHONIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    DYSPNOEA
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    EPISTAXIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
    2 / 16 (12.50%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    3
    3
    1
    0
    OROPHARYNGEAL PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    PRODUCTIVE COUGH
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    RHINORRHOEA
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Psychiatric disorders
    IRRITABILITY
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    2
    0
    2
    0
    AMYLASE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    0
    3
    0
    BLOOD ALKALINE PHOSPHATASE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    0
    9
    0
    BLOOD BILIRUBIN INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    BLOOD CREATININE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    5 / 41 (12.20%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    10
    0
    BLOOD PRESSURE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    EJECTION FRACTION DECREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    8
    0
    0
    0
    0
    0
    LIPASE INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    PLATELET COUNT DECREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    WEIGHT DECREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    3
    1
    0
    WEIGHT INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    ANKLE FRACTURE
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    FALL
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    3
    0
    INCISION SITE PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    RADIUS FRACTURE
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cardiac disorders
    BUNDLE BRANCH BLOCK RIGHT
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    CONGESTIVE CARDIOMYOPATHY
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    APHONIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    COMPLEX REGIONAL PAIN SYNDROME
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    DIZZINESS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    DYSAESTHESIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    DYSTONIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    FACIAL NEURALGIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    HEADACHE
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 7 (14.29%)
    6 / 14 (42.86%)
    1 / 16 (6.25%)
    4 / 41 (9.76%)
    0 / 6 (0.00%)
         occurrences all number
    5
    1
    7
    1
    6
    0
    HYPOAESTHESIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    MIGRAINE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    MOVEMENT DISORDER
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    NERVOUS SYSTEM DISORDER
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    NEUROPATHY PERIPHERAL
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    NEUROTOXICITY
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    PARAESTHESIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    2
    0
    PERIPHERAL SENSORY NEUROPATHY
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    SCIATICA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    SEIZURE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    SOMNOLENCE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    5 / 41 (12.20%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    20
    0
    LEUKOPENIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    0
    7
    0
    NEUTROPENIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    0
    12
    0
    0
    9
    0
    NEUTROPHILIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    THROMBOCYTOPENIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    10
    0
    Ear and labyrinth disorders
    EAR PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    VERTIGO
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eye disorders
    CONJUNCTIVAL HAEMORRHAGE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    LACRIMATION INCREASED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    PERIORBITAL DISORDER
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    XEROPHTHALMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    21
    1
    0
    0
    2
    0
    ABDOMINAL PAIN UPPER
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    CHEILITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    CONSTIPATION
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    DENTAL CARIES
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    DIARRHOEA
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    7 / 41 (17.07%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    2
    0
    19
    0
    DYSPEPSIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    GASTRITIS EROSIVE
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    GINGIVAL BLEEDING
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    MOUTH ULCERATION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    NAUSEA
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    3 / 16 (18.75%)
    5 / 41 (12.20%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    1
    7
    8
    0
    ORAL PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    PEPTIC ULCER
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    STOMATITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    TOOTHACHE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    VOMITING
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    5 / 41 (12.20%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    0
    0
    5
    1
    Skin and subcutaneous tissue disorders
    ALOPECIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    ERYTHEMA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    ONYCHOLYSIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    RASH
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    3
    1
    0
    RASH MACULAR
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    SKIN SWELLING
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Renal and urinary disorders
    PROTEINURIA
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 11 (54.55%)
    2 / 7 (28.57%)
    5 / 14 (35.71%)
    8 / 16 (50.00%)
    20 / 41 (48.78%)
    1 / 6 (16.67%)
         occurrences all number
    55
    5
    15
    26
    100
    1
    RENAL FAILURE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    RENAL IMPAIRMENT
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    URINARY INCONTINENCE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 7 (14.29%)
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    2
    0
    1
    0
    BACK PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    5 / 41 (12.20%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    5
    0
    MUSCLE SPASMS
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    6
    0
    0
    0
    2
    0
    MUSCULOSKELETAL DISCOMFORT
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    MUSCULOSKELETAL PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 11 (36.36%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    7
    0
    0
    2
    2
    0
    MYALGIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    NECK PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    OSTEOARTHRITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    PAIN IN EXTREMITY
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    3
    0
    PERIARTHRITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    SPINAL PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Infections and infestations
    BACTERIURIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    BREAST DISCHARGE INFECTED
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    BRONCHITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    CONJUNCTIVITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    CYSTITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    DIVERTICULITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    EAR INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    INFLUENZA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    0
    LACRIMAL GLAND ABSCESS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    NAIL INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    NASOPHARYNGITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    PERIODONTITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    RESPIRATORY TRACT INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    RHINITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    SINUSITIS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    TOOTH ABSCESS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    TOOTH INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    0
    UPPER RESPIRATORY TRACT INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 41 (4.88%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    1
    4
    0
    URINARY TRACT INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    9 / 41 (21.95%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    26
    1
    VIRAL UPPER RESPIRATORY TRACT INFECTION
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    2
    4
    0
    GOUT
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    HYPERGLYCAEMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    3 / 41 (7.32%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    15
    0
    HYPOALBUMINAEMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    4 / 41 (9.76%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    11
    0
    HYPOCALCAEMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    HYPOKALAEMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    HYPONATRAEMIA
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 41 (2.44%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    IRON DEFICIENCY
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 41 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    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
    15 Feb 2013
    Major changes included a change to study personnel and clarification of study phase.
    08 Nov 2018
    Changes to provide for transition of patients from supply of bevacizumab via this clinical study to commercial and Post-Trial Access Program supplies

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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