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    Clinical Trial Results:
    A randomized double-blind cross-over patient preference study of pazopanib vs. sunitinib in-treatment naïve locally advanced or metastatic renal cell carcinoma

    Summary
    EudraCT number
    		 2009-014249-10
    Trial protocol
    		 FI   DE   IT   GB  
    Global end of trial date
    23 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Dec 2016
    First version publication date
    09 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VEG113046
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01064310
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH - 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, 41 613241111,
    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
    23 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess how the tolerability and safety differences between pazopanib and sunitinib translated into patient preference, defined by the patient's stated preference for which drug they prefered.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 May 2010
    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
    France: 61
    Country: Number of subjects enrolled
    Italy: 40
    Country: Number of subjects enrolled
    United Kingdom: 37
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Finland: 14
    Worldwide total number of subjects
    168
    EEA total number of subjects
    168
    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)
    0
    From 65 to 84 years
    168
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 There were169 participants randomized and one participant randomized in error with no data available. Eighty-four patients entered open label pazopinib follow up until withdrawal for toxicity (12), disease progression (51),physician decision (20), subject decision (1). No new patients were added.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sunitinib 50 mg followed by pazopanib 800 mg
    Arm description
    		 Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks

    Investigational medicinal product name
    pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg followed by sunitinib 50 mg

    Arm title
    		 Pazopanib 800 mg followed by sunitinib 50 mg
    Arm description
    		 Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg followed by sunitinib 50 mg

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks

    Number of subjects in period 1
    		Sunitinib 50 mg followed by pazopanib 800 mg Pazopanib 800 mg followed by sunitinib 50 mg
    Started
    82
    86
    Completed
    68
    68
    Not completed
    14
    18
         Physician decision
    1
    -
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    7
    10
         Lack of efficacy
    3
    5
         Entered Open-label Period
    1
    1
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sunitinib 50 mg followed by pazopanib 800 mg
    Arm description
    		 Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg followed by sunitinib 50 mg

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks

    Arm title
    		 Pazopanib 800 mg followed by sunitinib 50 mg
    Arm description
    		 Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pazopanib 800 mg followed by sunitinib 50 mg

    Investigational medicinal product name
    Sunitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks

    Number of subjects in period 2
    		Sunitinib 50 mg followed by pazopanib 800 mg Pazopanib 800 mg followed by sunitinib 50 mg
    Started
    68
    68
    Completed
    64
    62
    Not completed
    4
    6
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    1
         Entered Open-label Period
    1
    -
         Lack of efficacy
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sunitinib 50 mg followed by pazopanib 800 mg
    Reporting group description
    		 Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.

    Reporting group title
    Pazopanib 800 mg followed by sunitinib 50 mg
    Reporting group description
    		 Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.

    Reporting group values
    		 Sunitinib 50 mg followed by pazopanib 800 mg Pazopanib 800 mg followed by sunitinib 50 mg Total
    Number of subjects
    		 82 86 168
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 46 48 94
        From 65-84 years
    		 36 38 74
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.1 ( 9.56 ) 62.2 ( 11.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 25 55
        Male
    		 52 61 113
    RaceEthnicityOther
    Units: Subjects
        African American/African Heritage
    		 1 0 1
        Asian-Central/South Asian Heritage
    		 1 0 1
        White
    		 74 83 157
        Missing
    		 6 3 9

    End points

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    End points reporting groups
    Reporting group title
    Sunitinib 50 mg followed by pazopanib 800 mg
    Reporting group description
    		 Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.

    Reporting group title
    Pazopanib 800 mg followed by sunitinib 50 mg
    Reporting group description
    		 Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    Reporting group title
    Sunitinib 50 mg followed by pazopanib 800 mg
    Reporting group description
    		 Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.

    Reporting group title
    Pazopanib 800 mg followed by sunitinib 50 mg
    Reporting group description
    		 Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.

    Subject analysis set title
    Sunitinib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Sunitinib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Sunitinib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Sunitinib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Sunitinib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Sunitinib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Subject analysis set title
    Pazopanib
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.

    Primary: Number of participants with preference for pazopanib versus sunitinib as assessed by the patient preference questionnaire (PPQ)

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    End point title
    		 Number of participants with preference for pazopanib versus sunitinib as assessed by the patient preference questionnaire (PPQ)
    End point description
    The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
    End point type
    Primary
    End point timeframe
    End of treatment of both study drugs (maximum of 22 weeks)
    End point values
    		 Sunitinib 50 mg followed by pazopanib 800 mg Pazopanib 800 mg followed by sunitinib 50 mg
    Number of subjects analysed
    60
    54
    Units: participants
        Sunitinib
    19
    6
        Pazopanib
    37
    43
        No preference
    4
    5
    Statistical analysis title
    		 difference in preference
    Comparison groups
    Sunitinib 50 mg followed by pazopanib 800 mg v Pazopanib 800 mg followed by sunitinib 50 mg
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [1]
    Method
    		 Prescotts test
    Parameter type
    		 Percentage of participants
    Point estimate
    49.26
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 37
         upper limit
    		 61.5
    Notes
    [1] - The p value indicates the difference in preference for pazopanib versus sunitinib treatment

    Primary: Number of participants answering "yes," "no," or not applicable (N/A) to the question of whether the indicated factors influenced their preference for sunitinib or pazopanib treatment as assessed by the patient preference questionnaire

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    End point title
    		 Number of participants answering "yes," "no," or not applicable (N/A) to the question of whether the indicated factors influenced their preference for sunitinib or pazopanib treatment as assessed by the patient preference questionnaire [2]
    End point description
    The PPQ is used to measure participants’ preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference. No statistical analysis was performed for this endpoint.
    End point type
    Primary
    End point timeframe
    End of treatment of both study drugs (maximum of 22 weeks)
    Notes
    [2] - 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: No statistical analysis was performed for this endpoint.
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    25
    80
    Units: participants
        Fatigue had less impact on life, Yes
    12
    47
        Fatigue had less impact on life, No
    8
    26
        Fatigue had less impact on life, not applicable (N
    5
    6
        Soreness in hands/feet had less impact, Yes
    6
    30
        Soreness in hands/feet had less impact, No
    7
    22
        Soreness in hands/feet had less impact, NA
    12
    28
        Soreness in mouth/throat had less impact, Yes
    6
    32
        Soreness in mouth/throat had less impact, No
    8
    25
        Soreness in mouth/throat had less impact, NA
    11
    23
        Loss of appetite had less impact, Yes
    10
    28
        Loss of appetite had less impact, No
    8
    28
        Loss of appetite had less impact, NA
    7
    22
        Change in hair color had less impact, Yes
    5
    9
        Change in hair color had less impact, No
    11
    51
        Change in hair color had less impact, NA
    9
    20
        Nausea/vomiting had less impact, Yes
    11
    32
        Nausea/vomiting had less impact, No
    7
    30
        Nausea/vomiting had less impact, NA
    7
    17
        Diarrhea had less impact, Yes
    16
    21
        Diarrhea had less impact, No
    5
    44
        Diarrhea had less impact, NA
    4
    15
        Pain in stomach area had less impact, Yes
    9
    23
        Pain in stomach area had less impact, No
    4
    30
        Pain in stomach area had less impact, NA
    12
    27
        Changes in food tastes had less impact, Yes
    5
    44
        Changes in food tastes had less impact, No
    14
    23
        Changes in food tastes had less impact, NA
    6
    12
        Quality of life better, Yes
    15
    65
        Quality of life better, No
    6
    12
        Quality of life better, NA
    4
    2
        Other, Yes
    5
    14
        Other, No
    0
    0
        Other, NA
    20
    66
    No statistical analyses for this end point

    Secondary: Change from Period Baseline (BL) in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score

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    End point title
    		 Change from Period Baseline (BL) in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score
    End point description
    Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.
    End point type
    Secondary
    End point timeframe
    Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])
    End point values
    		 Sunitinib 50 mg followed by pazopanib 800 mg Pazopanib 800 mg followed by sunitinib 50 mg
    Number of subjects analysed
    77
    79
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Period 1 Average; n=77, 79
    -4.4 ( 7.73 )
    -4.6 ( 9.22 )
        Period 2 Average; n=63, 65
    -3.6 ( 7.11 )
    -7.3 ( 11.16 )
    No statistical analyses for this end point

    Secondary: Quality of life as assessed by the EuroQoL-5 Dimensions (EQ-5D) thermometer and utility scores

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    End point title
    		 Quality of life as assessed by the EuroQoL-5 Dimensions (EQ-5D) thermometer and utility scores
    End point description
    The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
    End point type
    Secondary
    End point timeframe
    Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])
    End point values
    		 Sunitinib 50 mg followed by pazopanib 800 mg Pazopanib 800 mg followed by sunitinib 50 mg
    Number of subjects analysed
    80
    86
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Thermometer Score, Day 1; n=74, 79
    75.7 ( 17.65 )
    74.8 ( 18.54 )
        Thermometer Score, Washout; n=60, 63
    74.4 ( 16.76 )
    69.8 ( 19.94 )
        Thermometer Score, End of Study; n=51, 45
    71.3 ( 16.19 )
    65.1 ( 22.55 )
        Utility Score, Day 1; n=76, 81
    0.7625 ( 0.25331 )
    0.7664 ( 0.22946 )
        Utility Score, Washout; n=61, 67
    0.8103 ( 0.20776 )
    0.7595 ( 0.26826 )
        Utility Score, End of Study; n=52, 47
    0.7487 ( 0.21324 )
    0.6325 ( 0.29635 )
    No statistical analyses for this end point

    Secondary: Time to dose modification

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    End point title
    		 Time to dose modification
    End point description
    For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
    End point type
    Secondary
    End point timeframe
    End of second treatment period (maximum of 22 weeks)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    30
    20
    Units: weeks
        median (confidence interval 95%)
    3.7 (2.7 to 5.9)
    4 (2.1 to 6)
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated number of dose reductions

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    End point title
    		 Number of participants with the indicated number of dose reductions
    End point description
    Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
    End point type
    Secondary
    End point timeframe
    End of second treatment period (maximum of 22 weeks)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    30
    20
    Units: participants
        1 dose reduction
    16
    8
        2 dose reductions
    10
    11
        3 or more dose reductions
    4
    1
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated reason for receiving a dose reduction

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    End point title
    		 Number of participants with the indicated reason for receiving a dose reduction
    End point description
    Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
    End point type
    Secondary
    End point timeframe
    End of second treatment period (maximum of 22 weeks)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    30
    20
    Units: participants
        Adverse Event
    46
    33
        Other
    3
    0
    No statistical analyses for this end point

    Secondary: Number of participants with Grade 1 to Grade 5 adverse events (AEs)

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    End point title
    		 Number of participants with Grade 1 to Grade 5 adverse events (AEs)
    End point description
    AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
    End point type
    Secondary
    End point timeframe
    Baseline to end of study (maximum of 22 weeks)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    148
    153
    Units: participants
        Grade 0
    0
    0
        Grade 1
    20
    25
        Grade 2
    57
    63
        Grade 3
    58
    51
        Grade 4
    11
    8
        Grade 5
    1
    0
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated AEs leading to permanent discontinuation of study treatment

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    End point title
    		 Number of participants with the indicated AEs leading to permanent discontinuation of study treatment
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.
    End point type
    Secondary
    End point timeframe
    Baseline to end of study (maximum of 22 weeks)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    38
    25
    Units: participants
        Fatigue
    5
    3
        Alanine aminotransferase increased
    2
    4
        Vomiting
    1
    3
        Aspartate aminotransferase increased
    0
    3
        Diarrhoea
    1
    2
        Thrombocytopenia
    3
    0
        Acute myocardial infarction
    1
    1
        Asthenia
    2
    0
        Back pain
    1
    1
        Dyspnoea
    2
    0
        Epistaxis
    2
    0
        Hypertension
    2
    0
        Nasal congestion
    1
    1
        Pleural effusion
    2
    0
        Transient ischaemic attack
    0
    2
        Atrial flutter
    0
    1
        Blood potassium decreased
    1
    0
        Cardiac disorder
    0
    1
        Cardiac failure
    0
    1
        Cough
    1
    0
        Decreased appetite
    1
    0
        Dizziness
    0
    1
        Dysgeusia
    0
    1
        Haematemesis
    0
    1
        Haematoma
    1
    0
        Haematuria
    1
    0
        Haemorrhage intracranial
    1
    0
        Headache
    1
    0
        Hepatic function abnormal
    0
    1
        Hepatotoxicity
    0
    1
        Infection
    1
    0
        Infectious peritonitis
    0
    1
        Influenza
    1
    0
        Influenza like illness
    1
    0
        Mucosal inflammation
    1
    0
        Myocardial ischaemia
    0
    1
        Nausea
    0
    1
        Neutropenic infection
    1
    0
        Ovarian cyst
    1
    0
        Pain in extremity
    1
    0
        Palmar-plantar erythrodysaesthesia syndrome
    1
    0
        Pancytopenia
    1
    0
        Proteinuria
    0
    1
        Pyrexia
    1
    0
        Rash
    0
    1
        Renal failure
    1
    0
        Respiratory failure
    0
    1
        Sinusitis
    1
    0
        Skin ulcer
    0
    1
        Spinal cord compression
    0
    1
        Stomatitis
    1
    0
        Tooth infection
    1
    0
        Transaminases increased
    1
    0
        Urine protein/creatinine ratio decreased
    1
    0
        Weight decreased
    1
    0
    No statistical analyses for this end point

    Secondary: Change from baseline (BL) in systolic blood pressure (SBP) and diastolic BP (DBP)

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    End point title
    		 Change from baseline (BL) in systolic blood pressure (SBP) and diastolic BP (DBP)
    End point description
    When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    139
    147
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP, Week 2; n=139, 147
    6.3 ( 15.26 )
    7.5 ( 16.36 )
        SBP, Week 6; n=109, 134
    -0.4 ( 18.65 )
    7.5 ( 17.21 )
        SBP, Week 10; n=61, 64
    4.5 ( 18.43 )
    4.7 ( 20.45 )
        DBP, Week 2; n=139, 147
    6.5 ( 9.91 )
    6.5 ( 10.49 )
        DBP, Week 6; n=109, 134
    -0.4 ( 9.48 )
    6.9 ( 10.87 )
        DBP, Week 10; n=61, 64
    3.1 ( 10.69 )
    5.6 ( 11.44 )
    No statistical analyses for this end point

    Secondary: Change from baseline (BL) in heart rate

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    End point title
    		 Change from baseline (BL) in heart rate
    End point description
    Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)
    End point values
    		 Sunitinib Pazopanib
    Number of subjects analysed
    137
    145
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Week 2, n=137, 145
    -3.1 ( 12.39 )
    -2.7 ( 13.09 )
        Week 6, n=106, 131
    0.8 ( 11.43 )
    -3.3 ( 12.41 )
        Week 10, n=60, 64
    -3.8 ( 13.54 )
    -1.8 ( 13.84 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious Adverse Events field "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Pazopanib
    Reporting group description
    		 Pazopanib

    Reporting group title
    Sunitinib
    Reporting group description
    		 Sunitinib

    Reporting group title
    Open Label Pazopanib
    Reporting group description
    		 Open Label Pazopanib

    Serious adverse events
    		 Pazopanib Sunitinib Open Label Pazopanib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 153 (19.61%)
    35 / 148 (23.65%)
    15 / 84 (17.86%)
         number of deaths (all causes)
    4
    5
    3
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to bone
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Metastases to central nervous system
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Tumour haemorrhage
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    3 / 153 (1.96%)
    2 / 148 (1.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 153 (1.31%)
    3 / 148 (2.03%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 153 (0.00%)
    3 / 148 (2.03%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Oedema peripheral
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Performance status decreased
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Dyspnoea
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Epistaxis
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 148 (1.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 153 (0.65%)
    2 / 148 (1.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 153 (1.96%)
    2 / 148 (1.35%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipase abnormal
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Incisional hernia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheal obstruction
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Upper limb fracture
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysgeusia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Partial seizures
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Transient ischaemic attack
         subjects affected / exposed
    2 / 153 (1.31%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 153 (1.31%)
    3 / 148 (2.03%)
    2 / 84 (2.38%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 153 (0.00%)
    3 / 148 (2.03%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    7 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Anal fistula
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 148 (1.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 153 (0.65%)
    2 / 148 (1.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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 and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 153 (0.65%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Osteoarthritis
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 148 (1.35%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (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
    Neutropenic infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (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
    Pneumonia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 148 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 148 (0.68%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pazopanib Sunitinib Open Label Pazopanib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    142 / 153 (92.81%)
    143 / 148 (96.62%)
    73 / 84 (86.90%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    32 / 153 (20.92%)
    37 / 148 (25.00%)
    13 / 84 (15.48%)
         occurrences all number
    44
    52
    33
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    26 / 153 (16.99%)
    35 / 148 (23.65%)
    16 / 84 (19.05%)
         occurrences all number
    34
    51
    23
    Fatigue
         subjects affected / exposed
    43 / 153 (28.10%)
    42 / 148 (28.38%)
    25 / 84 (29.76%)
         occurrences all number
    71
    69
    62
    Mucosal inflammation
         subjects affected / exposed
    25 / 153 (16.34%)
    32 / 148 (21.62%)
    6 / 84 (7.14%)
         occurrences all number
    27
    51
    8
    Pyrexia
         subjects affected / exposed
    5 / 153 (3.27%)
    10 / 148 (6.76%)
    1 / 84 (1.19%)
         occurrences all number
    5
    11
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 153 (3.92%)
    10 / 148 (6.76%)
    5 / 84 (5.95%)
         occurrences all number
    6
    11
    5
    Dysphonia
         subjects affected / exposed
    7 / 153 (4.58%)
    2 / 148 (1.35%)
    6 / 84 (7.14%)
         occurrences all number
    7
    2
    7
    Dyspnoea
         subjects affected / exposed
    12 / 153 (7.84%)
    7 / 148 (4.73%)
    6 / 84 (7.14%)
         occurrences all number
    12
    10
    7
    Epistaxis
         subjects affected / exposed
    8 / 153 (5.23%)
    15 / 148 (10.14%)
    7 / 84 (8.33%)
         occurrences all number
    11
    19
    9
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    9 / 153 (5.88%)
    5 / 148 (3.38%)
    7 / 84 (8.33%)
         occurrences all number
    13
    6
    12
    Blood creatinine increased
         subjects affected / exposed
    2 / 153 (1.31%)
    5 / 148 (3.38%)
    5 / 84 (5.95%)
         occurrences all number
    2
    5
    12
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 148 (1.35%)
    5 / 84 (5.95%)
         occurrences all number
    0
    2
    6
    Weight decreased
         subjects affected / exposed
    9 / 153 (5.88%)
    7 / 148 (4.73%)
    9 / 84 (10.71%)
         occurrences all number
    12
    8
    9
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    25 / 153 (16.34%)
    40 / 148 (27.03%)
    12 / 84 (14.29%)
         occurrences all number
    28
    45
    14
    Headache
         subjects affected / exposed
    22 / 153 (14.38%)
    17 / 148 (11.49%)
    7 / 84 (8.33%)
         occurrences all number
    33
    20
    9
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 153 (2.61%)
    5 / 148 (3.38%)
    5 / 84 (5.95%)
         occurrences all number
    4
    8
    5
    Neutropenia
         subjects affected / exposed
    6 / 153 (3.92%)
    8 / 148 (5.41%)
    4 / 84 (4.76%)
         occurrences all number
    9
    19
    10
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    20 / 153 (13.07%)
    16 / 148 (10.81%)
    11 / 84 (13.10%)
         occurrences all number
    25
    19
    17
    Abdominal pain upper
         subjects affected / exposed
    7 / 153 (4.58%)
    19 / 148 (12.84%)
    8 / 84 (9.52%)
         occurrences all number
    10
    19
    8
    Constipation
         subjects affected / exposed
    13 / 153 (8.50%)
    23 / 148 (15.54%)
    10 / 84 (11.90%)
         occurrences all number
    13
    31
    10
    Diarrhoea
         subjects affected / exposed
    63 / 153 (41.18%)
    49 / 148 (33.11%)
    45 / 84 (53.57%)
         occurrences all number
    106
    64
    130
    Dyspepsia
         subjects affected / exposed
    17 / 153 (11.11%)
    23 / 148 (15.54%)
    6 / 84 (7.14%)
         occurrences all number
    18
    28
    7
    Flatulence
         subjects affected / exposed
    10 / 153 (6.54%)
    5 / 148 (3.38%)
    5 / 84 (5.95%)
         occurrences all number
    10
    5
    5
    Haemorrhoids
         subjects affected / exposed
    3 / 153 (1.96%)
    10 / 148 (6.76%)
    1 / 84 (1.19%)
         occurrences all number
    4
    14
    1
    Nausea
         subjects affected / exposed
    50 / 153 (32.68%)
    46 / 148 (31.08%)
    26 / 84 (30.95%)
         occurrences all number
    62
    57
    42
    Stomatitis
         subjects affected / exposed
    7 / 153 (4.58%)
    22 / 148 (14.86%)
    5 / 84 (5.95%)
         occurrences all number
    7
    31
    8
    Vomiting
         subjects affected / exposed
    21 / 153 (13.73%)
    26 / 148 (17.57%)
    18 / 84 (21.43%)
         occurrences all number
    30
    31
    38
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 153 (0.00%)
    8 / 148 (5.41%)
    0 / 84 (0.00%)
         occurrences all number
    0
    10
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    11 / 153 (7.19%)
    6 / 148 (4.05%)
    6 / 84 (7.14%)
         occurrences all number
    11
    7
    6
    Dry skin
         subjects affected / exposed
    6 / 153 (3.92%)
    14 / 148 (9.46%)
    6 / 84 (7.14%)
         occurrences all number
    6
    15
    6
    Erythema
         subjects affected / exposed
    8 / 153 (5.23%)
    5 / 148 (3.38%)
    3 / 84 (3.57%)
         occurrences all number
    10
    6
    3
    Hair colour changes
         subjects affected / exposed
    26 / 153 (16.99%)
    19 / 148 (12.84%)
    9 / 84 (10.71%)
         occurrences all number
    27
    19
    9
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    27 / 153 (17.65%)
    39 / 148 (26.35%)
    11 / 84 (13.10%)
         occurrences all number
    36
    65
    22
    Rash
         subjects affected / exposed
    13 / 153 (8.50%)
    17 / 148 (11.49%)
    10 / 84 (11.90%)
         occurrences all number
    16
    18
    14
    Skin depigmentation
         subjects affected / exposed
    8 / 153 (5.23%)
    6 / 148 (4.05%)
    1 / 84 (1.19%)
         occurrences all number
    8
    6
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    6 / 153 (3.92%)
    6 / 148 (4.05%)
    5 / 84 (5.95%)
         occurrences all number
    6
    6
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    11 / 153 (7.19%)
    5 / 148 (3.38%)
    6 / 84 (7.14%)
         occurrences all number
    12
    6
    6
    Back pain
         subjects affected / exposed
    13 / 153 (8.50%)
    9 / 148 (6.08%)
    4 / 84 (4.76%)
         occurrences all number
    15
    10
    4
    Muscle spasms
         subjects affected / exposed
    9 / 153 (5.88%)
    6 / 148 (4.05%)
    6 / 84 (7.14%)
         occurrences all number
    11
    7
    9
    Myalgia
         subjects affected / exposed
    5 / 153 (3.27%)
    5 / 148 (3.38%)
    5 / 84 (5.95%)
         occurrences all number
    6
    5
    7
    Pain in extremity
         subjects affected / exposed
    9 / 153 (5.88%)
    10 / 148 (6.76%)
    2 / 84 (2.38%)
         occurrences all number
    10
    11
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 148 (0.00%)
    5 / 84 (5.95%)
         occurrences all number
    0
    0
    7
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 153 (0.00%)
    2 / 148 (1.35%)
    6 / 84 (7.14%)
         occurrences all number
    0
    2
    7
    Urinary tract infection
         subjects affected / exposed
    5 / 153 (3.27%)
    4 / 148 (2.70%)
    5 / 84 (5.95%)
         occurrences all number
    5
    4
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    32 / 153 (20.92%)
    30 / 148 (20.27%)
    18 / 84 (21.43%)
         occurrences all number
    36
    35
    26

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Mar 2011
    Updated Hepatotoxicity Management Guidelines and corrected minor errors in the protocol. Added text for clarification SAE reporting procedure, blood pressure measurement requirements, completion definition, dose modifications, drug supply storage, recommendations for patients who previously received or currently were receiving IV bisphosphonates, timing of study procedures and PK assessments. Declaration of Helsinski wording updated and definition of end of study added.
    04 Jan 2013
    This amendment permits continued access to clinical trial material for subjects ongoing at the time of implementation of this amendment with adjustment to the frequency of clinic visits, and labs. Subject treatment and disease management will be as indicated by local standard of medical care and local approved labeling (or the DCSI) for pazopanib. Investigators will be required to collect and report to the Sponsor all SAEs and pregnancies, AEs leading to IP discontinuation or other AEs the investigator deems important to report, and all other reasons leading to IP discontinuation. Collection of additional safety information will no longer be required by the Sponsor but will be at the discretion and judgment of the investigator in accordance with the local standard of medical care. Change 3 – Appropriate subjects may be withdrawn from Study VEG113046 and may continue pazopanib therapy via an alternative approved mechanism.

    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.
    The study remained open to allow subjects currently on treatment continued access to treatment with open label pazopanib.
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    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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