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    Clinical Trial Results:
    A prospective international multicenter Phase II study to evaluate the efficacy, safety and quality of life of oral daily pazopanib in patients with advanced and/or metastatic renal cell carcinoma after previous therapy with checkpoint inhibitor treatment

    Summary
    EudraCT number
    		 2017-000708-10
    Trial protocol
    		 CZ   DE   ES   AT   GB   HU  
    Global end of trial date
    10 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2022
    First version publication date
    31 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CPZP034A2410
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03200717
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.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
    10 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to assess the progression-free survival (PFS) based on local investigator assessment.
    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
    14 Nov 2017
    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
    Germany: 7
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United States: 1
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Chile: 24
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    United Kingdom: 7
    Worldwide total number of subjects
    62
    EEA total number of subjects
    28
    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)
    32
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted across 22 centers in 11 countries

    Pre-assignment
    Screening details
    		 A total of 87 participants were screened of which 62 participants were enrolled in the this study to receive study treatment.

    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
    		 Pazopanib- 2nd line
    Arm description
    		 Participants received pazopanib as 2nd line treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    PZP034
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg of pazopanib once daily orally

    Arm title
    		 Pazopanib- 3rd line
    Arm description
    		 Participants received pazopanib as 3rd line treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    PZP034
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg of pazopanib once daily orally

    Number of subjects in period 1
    		Pazopanib- 2nd line Pazopanib- 3rd line
    Started
    47
    15
    Completed
    6
    0
    Not completed
    41
    15
         Adverse event, serious fatal
    2
    -
         Physician decision
    3
    2
         Adverse event, non-fatal
    11
    8
         Subject/Guardian Decision
    1
    -
         Progressive disease
    24
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pazopanib- 2nd line
    Reporting group description
    		 Participants received pazopanib as 2nd line treatment

    Reporting group title
    Pazopanib- 3rd line
    Reporting group description
    		 Participants received pazopanib as 3rd line treatment

    Reporting group values
    		 Pazopanib- 2nd line Pazopanib- 3rd line Total
    Number of subjects
    		 47 15 62
    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)
    		 26 6 32
        From 65-84 years
    		 21 9 30
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 62.4 ± 11.55 65.4 ± 9.77 -
    Sex: Female, Male
    Units: Participants
        Female
    		 11 4 15
        Male
    		 36 11 47
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 44 13 57
        Asian
    		 1 0 1
        Other
    		 0 1 1
        Unknown
    		 2 1 3
    Subject analysis sets

    Subject analysis set title
    All participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received pazopanib as 2nd or 3rd line treatment

    Subject analysis sets values
    		 All participants
    Number of subjects
    62
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    32
        From 65-84 years
    30
        85 years and over
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    63.2 ± 11.15
    Sex: Female, Male
    Units: Participants
        Female
    47
        Male
    15
    Race/Ethnicity, Customized
    Units: Subjects
        White
    57
        Asian
    3
        Other
    1
        Unknown
    1

    End points

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    End points reporting groups
    Reporting group title
    Pazopanib- 2nd line
    Reporting group description
    		 Participants received pazopanib as 2nd line treatment

    Reporting group title
    Pazopanib- 3rd line
    Reporting group description
    		 Participants received pazopanib as 3rd line treatment

    Subject analysis set title
    All participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants who received pazopanib as 2nd or 3rd line treatment

    Primary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS) [1]
    End point description
    PFS is defined as the time from the start date of pazopanib treatment to the date of the first documented progression or death due to any cause. PFS was assessed via local review according to RECIST 1.1. PFS was censored at the date of the last adequate tumor assessment if no PFS event (disease progression or death due to any cause) was observed prior to the analysis cut-off date. The PFS distribution was estimated using the Kaplan-Meier method.
    End point type
    Primary
    End point timeframe
    Date of first treatment to date of progression or death up to approximately 38 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: No statistical analyses were planned for this endpoint
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Months
        median (confidence interval 95%)
    7.5 (3.7 to 12.6)
    4.6 (3.3 to 9.2)
    6.8 (3.7 to 11.1)
    No statistical analyses for this end point

    Secondary: Overall response rate (ORR) based on local investigator assessment according to RECIST v1.1

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    End point title
    		 Overall response rate (ORR) based on local investigator assessment according to RECIST v1.1
    End point description
    ORR is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator’s assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
    End point type
    Secondary
    End point timeframe
    Up to approximately 38 months
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Percentage of participants
        number (confidence interval 95%)
    23.4 (12.3 to 38.0)
    0 (0.0 to 21.8)
    17.7 (9.2 to 29.5)
    No statistical analyses for this end point

    Secondary: Clinical benefit rate (CBR) based on local investigator assessment according to RECIST v1.1.

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    End point title
    		 Clinical benefit rate (CBR) based on local investigator assessment according to RECIST v1.1.
    End point description
    CBR is defined as the percentage of participants with a best overall response of CR or PR or an overall lesion response of stable disease (SD) or Non-CR/Non-PD lasting ≥ 24 weeks based on local investigator’s assessment according to RECIST v1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
    End point type
    Secondary
    End point timeframe
    Up to approximately 38 months
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Percentage of participants
        number (confidence interval 95%)
    53.2 (38.1 to 67.9)
    40.0 (16.3 to 67.7)
    50.0 (37.0 to 63.0)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS is defined as the time from the first administration of study treatment until death due to any cause. If a participant was not known to have died, survival was censored at the date of last known date patient alive. The OS distribution was estimated using the Kaplan-Meier method. 999 indicates data was not evaluable
    End point type
    Secondary
    End point timeframe
    From date of first treatment to date of death, up to approximately 44 months
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Months
        median (confidence interval 95%)
    27.8 (14.9 to 999)
    20.0 (9.2 to 25.6)
    23.4 (14.9 to 31.8)
    No statistical analyses for this end point

    Secondary: Duration of response (DOR) based on local Investigators assessment according to RECIST v1.1

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    End point title
    		 Duration of response (DOR) based on local Investigators assessment according to RECIST v1.1
    End point description
    DOR is defined as the time from the date of first documented response (confirmed CR or PR according to RECIST v1.1 based on local Investigators review of tumor assessment data) to the date of tumor progression, or death due to underlying cancer, whichever comes first. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. The DOR distribution was calculated using the Kaplan-Meier method. 999 indicates data was not evaluable
    End point type
    Secondary
    End point timeframe
    From the date of first documented response (confirmed CR or PR) to the date of tumor progression, up to approximately 36 months
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line
    Number of subjects analysed
    11
    0 [2]
    Units: Months
        median (confidence interval 95%)
    999 (9.5 to 999)
    ( to )
    Notes
    [2] - No participant had an event (CR or PR)
    No statistical analyses for this end point

    Secondary: Change from baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) score

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    End point title
    		 Change from baseline in Functional Assessment of Cancer Therapy- Kidney Symptom (FKSI-DRS) score
    End point description
    FKSI-DRS is a 9-item questionnaire specifically designed to evaluate symptoms that are directly attributable to kidney cancer and includes patient’s symptoms in the past seven days such as lack of energy, pain, bone-pain, shortness of breath, fatigue, blood in urine, etc. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (no symptoms) to 36 (most severe symptoms) with a higher score indicating greater presence of kidney cancer symptoms. The baseline is defined as the last FKSI-DRS assessment on or prior to first day of treatment. A negative change from baseline indicates improvement in kidney cancer symptom status. 999 indicates data was not available
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Cycle 2 Day 1
    -1.3 ± 4.95
    -0.3 ± 4.31
    -1.0 ± 4.78
        Cycle 3 Day 1
    -0.5 ± 4.55
    1.7 ± 4.18
    -0.0 ± 4.51
        Cycle 4 Day 1
    -0.1 ± 2.97
    1.8 ± 4.22
    0.2 ± 3.24
        Cycle 5 Day 1
    0.1 ± 3.13
    2.0 ± 2.35
    0.4 ± 3.06
        Cycle 6 Day 1
    -0.3 ± 5.68
    2.7 ± 3.27
    0.3 ± 5.36
        Cycle 7 Day 1
    -0.1 ± 3.47
    2.5 ± 3.73
    0.4 ± 3.63
        Cycle 9 Day 1
    -0.1 ± 4.22
    999 ± 999
    -0.1 ± 4.22
        Cycle 11 Day 1
    0.7 ± 3.30
    0.0 ± 999
    0.6 ± 3.20
        Cycle 13 Day 1
    1.4 ± 2.12
    999 ± 999
    1.4 ± 2.12
        Cycle 16 Day 1
    0.6 ± 1.59
    999 ± 999
    0.6 ± 1.59
        Cycle 19 Day 1
    0.0 ± 2.76
    999 ± 999
    0.0 ± 2.76
        Cycle 22 Day 1
    -0.5 ± 3.27
    999 ± 999
    -0.5 ± 3.27
        Cycle 25 Day 1
    2.0 ± 2.31
    999 ± 999
    2.0 ± 2.31
        Cycle 28 Day 1
    999 ± 999
    999 ± 999
    999 ± 999
        Cycle 31 Day 1
    0.5 ± 0.71
    999 ± 999
    0.5 ± 0.71
        Cycle 34 Day 1
    1.0 ± 999
    999 ± 999
    1.0 ± 999
        Cycle 37 Day 1
    1.0 ± 999
    999 ± 999
    1 ± 999
        End of Treatment
    -0.6 ± 3.86
    -0.8 ± 6.00
    -0.6 ± 4.37
    No statistical analyses for this end point

    Secondary: Change from baseline in EuroQoL 5-level instrument Visual Analogue Scale (EQ-5L-5D VAS) score

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    End point title
    		 Change from baseline in EuroQoL 5-level instrument Visual Analogue Scale (EQ-5L-5D VAS) score
    End point description
    EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ-5L-5D VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating higher health-related quality of life. The baseline is defined as the last EQ-5L-5D assessment on or prior to first day of treatment. A positive change from baseline indicates improvement in the heath state. 999 indicates data was not available
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 9, 11, 13, 16 and every 3rd cycle thereafter until end of treatment, and end of treatment, assessed up to approximately 38 months. Cycle=28 days
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Cycle 2 Day 1
    0.1 ± 16.44
    -1.9 ± 19.46
    -0.4 ± 17.02
        Cycle 3 Day 1
    -2.8 ± 14.35
    3.6 ± 19.28
    -1.3 ± 15.58
        Cycle 4 Day 1
    -0.7 ± 10.88
    -1.5 ± 22.86
    -0.8 ± 13.27
        Cycle 5 Day 1
    -1.5 ± 13.61
    3.2 ± 19.51
    -0.7 ± 14.45
        Cycle 6 Day 1
    -1.3 ± 18.35
    -3.5 ± 24.09
    -1.7 ± 19.21
        Cycle 7 Day 1
    0.2 ± 11.89
    0.7 ± 20.37
    0.3 ± 13.73
        Cycle 9 Day 1
    3.8 ± 11.64
    999 ± 999
    3.8 ± 11.64
        Cycle 11 Day 1
    3.9 ± 12.62
    -2.0 ± 999
    3.5 ± 12.30
        Cycle 13 Day 1
    5.7 ± 12.26
    999 ± 999
    5.7 ± 12.26
        Cycle 16 Day 1
    -1.3 ± 11.70
    999 ± 999
    -1.3 ± 11.70
        Cycle 19 Day 1
    5.5 ± 10.09
    999 ± 999
    5.5 ± 10.09
        Cycle 22 Day 1
    0.5 ± 9.93
    999 ± 999
    0.5 ± 9.93
        Cycle 25 Day 1
    0.0 ± 9.70
    999 ± 999
    0.0 ± 9.70
        Cycle 28 Day 1
    999 ± 999
    999 ± 999
    999 ± 999
        Cycle 31 Day 1
    99.5 ± 0.71
    999 ± 999
    99.5 ± 0.71
        Cycle 34 Day 1
    10.0 ± 999
    999 ± 999
    10.0 ± 999
        Cycle 37 Day 1
    90.0 ± 999
    999 ± 999
    90.0 ± 999
        End of Treatment
    -1.9 ± 20.84
    -8.9 ± 19.99
    -3.6 ± 20.59
    No statistical analyses for this end point

    Post-hoc: All collected deaths

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    End point title
    		 All collected deaths
    End point description
    On-treatment deaths were collected from first dose of study medication to 30 days after the last dose of study medication, for a maximum duration of approximately 38 months. Post-treatment deaths were collected from day 31 after last dose of study medication to end of study, up to approximately 44 months. All deaths refer to the sum of on-treatment deaths and post-treatment deaths.
    End point type
    Post-hoc
    End point timeframe
    On-treatment deaths: Up to approximately 38 months. Post-treatment deaths: Up to approximately 44 months
    End point values
    		 Pazopanib- 2nd line Pazopanib- 3rd line All participants
    Number of subjects analysed
    47
    15
    62
    Units: Participants
        On-treatment deaths
    5
    1
    6
        Post-treatment deaths
    22
    10
    32
        All deaths
    27
    11
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of approximately 38 months
    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
    24.0
    Reporting groups
    Reporting group title
    Pazopanib- 2nd line
    Reporting group description
    		 Participants received pazopanib as 2nd line treatment

    Reporting group title
    All participants
    Reporting group description
    		 All participants who received pazopanib as 2nd or 3rd line treatment

    Reporting group title
    Pazopanib- 3rd line
    Reporting group description
    		 Participants received pazopanib as 3rd line treatment

    Serious adverse events
    		 Pazopanib- 2nd line All participants Pazopanib- 3rd line
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 47 (44.68%)
    30 / 62 (48.39%)
    9 / 15 (60.00%)
         number of deaths (all causes)
    5
    6
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 62 (3.23%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Immune system disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 47 (4.26%)
    5 / 62 (8.06%)
    3 / 15 (20.00%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (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
    Transaminases increased
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (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
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 62 (4.84%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pemphigoid
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 62 (3.23%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis viral
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 62 (1.61%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pazopanib- 2nd line All participants Pazopanib- 3rd line
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 47 (97.87%)
    60 / 62 (96.77%)
    14 / 15 (93.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    13 / 47 (27.66%)
    16 / 62 (25.81%)
    3 / 15 (20.00%)
         occurrences all number
    13
    16
    3
    Hypotension
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 47 (12.77%)
    6 / 62 (9.68%)
    0 / 15 (0.00%)
         occurrences all number
    7
    7
    0
    Fatigue
         subjects affected / exposed
    15 / 47 (31.91%)
    23 / 62 (37.10%)
    8 / 15 (53.33%)
         occurrences all number
    19
    32
    13
    Gait disturbance
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    4
    7
    3
    Pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    3
    4
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Dysphonia
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Cough
         subjects affected / exposed
    4 / 47 (8.51%)
    6 / 62 (9.68%)
    2 / 15 (13.33%)
         occurrences all number
    4
    6
    2
    Dyspnoea
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 62 (6.45%)
    2 / 15 (13.33%)
         occurrences all number
    2
    4
    2
    Epistaxis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 62 (3.23%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    2
    Haemoptysis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Pharyngeal erythema
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Sinus congestion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Pulmonary embolism
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 47 (14.89%)
    12 / 62 (19.35%)
    5 / 15 (33.33%)
         occurrences all number
    7
    12
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 47 (10.64%)
    9 / 62 (14.52%)
    4 / 15 (26.67%)
         occurrences all number
    5
    10
    5
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 47 (4.26%)
    6 / 62 (9.68%)
    4 / 15 (26.67%)
         occurrences all number
    2
    6
    4
    Blood bilirubin increased
         subjects affected / exposed
    3 / 47 (6.38%)
    7 / 62 (11.29%)
    4 / 15 (26.67%)
         occurrences all number
    3
    8
    5
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    3
    4
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Blood urea increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 47 (2.13%)
    4 / 62 (6.45%)
    3 / 15 (20.00%)
         occurrences all number
    1
    4
    3
    Lipase increased
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 62 (4.84%)
    0 / 15 (0.00%)
         occurrences all number
    3
    3
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Serum ferritin increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Transaminases increased
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 62 (4.84%)
    1 / 15 (6.67%)
         occurrences all number
    2
    3
    1
    Troponin T increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    8 / 47 (17.02%)
    10 / 62 (16.13%)
    2 / 15 (13.33%)
         occurrences all number
    8
    12
    4
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Dysgeusia
         subjects affected / exposed
    5 / 47 (10.64%)
    10 / 62 (16.13%)
    5 / 15 (33.33%)
         occurrences all number
    7
    13
    6
    Headache
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 62 (4.84%)
    2 / 15 (13.33%)
         occurrences all number
    1
    3
    2
    Lethargy
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    3
    4
    1
    Anaemia
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    3
    4
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 47 (10.64%)
    7 / 62 (11.29%)
    2 / 15 (13.33%)
         occurrences all number
    7
    11
    4
    Abdominal pain upper
         subjects affected / exposed
    5 / 47 (10.64%)
    5 / 62 (8.06%)
    0 / 15 (0.00%)
         occurrences all number
    5
    5
    0
    Diarrhoea
         subjects affected / exposed
    24 / 47 (51.06%)
    30 / 62 (48.39%)
    6 / 15 (40.00%)
         occurrences all number
    32
    39
    7
    Constipation
         subjects affected / exposed
    5 / 47 (10.64%)
    7 / 62 (11.29%)
    2 / 15 (13.33%)
         occurrences all number
    5
    7
    2
    Enterocolitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Gastritis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Gastrointestinal pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    3
    3
    Haemorrhoids
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Nausea
         subjects affected / exposed
    12 / 47 (25.53%)
    16 / 62 (25.81%)
    4 / 15 (26.67%)
         occurrences all number
    13
    19
    6
    Rectal haemorrhage
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Stomatitis
         subjects affected / exposed
    6 / 47 (12.77%)
    8 / 62 (12.90%)
    2 / 15 (13.33%)
         occurrences all number
    7
    9
    2
    Vomiting
         subjects affected / exposed
    6 / 47 (12.77%)
    9 / 62 (14.52%)
    3 / 15 (20.00%)
         occurrences all number
    6
    9
    3
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 62 (6.45%)
    0 / 15 (0.00%)
         occurrences all number
    4
    4
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Dry skin
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Erythema
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 62 (4.84%)
    1 / 15 (6.67%)
         occurrences all number
    2
    3
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    5 / 47 (10.64%)
    8 / 62 (12.90%)
    3 / 15 (20.00%)
         occurrences all number
    5
    10
    5
    Pruritus
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 62 (4.84%)
    0 / 15 (0.00%)
         occurrences all number
    3
    3
    0
    Rash
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    3
    4
    1
    Rash macular
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Proteinuria
         subjects affected / exposed
    3 / 47 (6.38%)
    5 / 62 (8.06%)
    2 / 15 (13.33%)
         occurrences all number
    4
    6
    2
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    3 / 47 (6.38%)
    6 / 62 (9.68%)
    3 / 15 (20.00%)
         occurrences all number
    3
    6
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 62 (6.45%)
    0 / 15 (0.00%)
         occurrences all number
    4
    4
    0
    Back pain
         subjects affected / exposed
    5 / 47 (10.64%)
    5 / 62 (8.06%)
    0 / 15 (0.00%)
         occurrences all number
    5
    5
    0
    Flank pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Joint swelling
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    3 / 47 (6.38%)
    4 / 62 (6.45%)
    1 / 15 (6.67%)
         occurrences all number
    3
    4
    1
    Pain in extremity
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    2
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 62 (4.84%)
    1 / 15 (6.67%)
         occurrences all number
    2
    4
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 62 (4.84%)
    1 / 15 (6.67%)
         occurrences all number
    2
    3
    1
    Rhinitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    14 / 47 (29.79%)
    17 / 62 (27.42%)
    3 / 15 (20.00%)
         occurrences all number
    16
    20
    4
    Hyperglycaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 62 (3.23%)
    1 / 15 (6.67%)
         occurrences all number
    2
    3
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 62 (3.23%)
    2 / 15 (13.33%)
         occurrences all number
    0
    2
    2
    Iron deficiency
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 62 (1.61%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2018
    The sample size was reduced from 140 to approximately 100 subjects, considering the potential challenges in the recruitment with the availability of other treatment options in the RCC landscape. The number of prior lines of therapy was captured in the IRT system at screening, with an enrolment cap of 60 subjects receiving pazopanib in 3L, to ensure that at least 40 subjects would be in the 2L treatment subgroup. As there was limited evidence to support re-challenge with pazopanib after prior 1st line pazopanib followed by ICI, the exclusion criteria were modified to exclude subjects with previous exposure to pazopanib. To allow for early monitoring of blood pressure soon after starting treatment with pazopanib, vital signs measurement was added on Cycle 1 Day 8. The frequency of cardiac imaging was reduced to every 5-6 cycles unless otherwise indicated.
    14 Sep 2020
    Novartis procedures for collecting follow up information on pregnancies were revised to harmonize follow-up timelines across product platforms. The follow up period for collecting information after a live birth has been extended from 3 months to 12 months.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results.
    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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