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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients with Locally Advanced and/or Metastatic Renal Cell Carcinoma Who Have Progressed Following Cytokine-based First-line Treatment

    Summary
    EudraCT number
    		 2005-004078-25
    Trial protocol
    		 GB   IE   SK   LT   EE   AT   CZ   IT   GR   HU   LV  
    Global end of trial date
    29 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2016
    First version publication date
    26 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VEG105192
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    05 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate and compare Progression Free Survival (PFS) of patients treated with pazopanib to those treated with placebo.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 108
    Country: Number of subjects enrolled
    Russian Federation: 32
    Country: Number of subjects enrolled
    France: 22
    Country: Number of subjects enrolled
    Slovakia: 18
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    Austria: 12
    Country: Number of subjects enrolled
    Czech Republic: 14
    Country: Number of subjects enrolled
    Estonia: 9
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Lithuania: 19
    Country: Number of subjects enrolled
    Chile: 21
    Country: Number of subjects enrolled
    India: 13
    Country: Number of subjects enrolled
    Korea, Republic of: 22
    Country: Number of subjects enrolled
    Argentina: 25
    Country: Number of subjects enrolled
    Brazil: 11
    Country: Number of subjects enrolled
    China: 6
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    Pakistan: 15
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Ukraine: 13
    Country: Number of subjects enrolled
    Hong Kong: 3
    Country: Number of subjects enrolled
    Latvia: 2
    Worldwide total number of subjects
    435
    EEA total number of subjects
    249
    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)
    281
    From 65 to 84 years
    153
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants with advanced renal cell carcinoma who were either treatment naïve, or had received one prior cytokine-based systemic treatment for advanced renal cell carcinoma (RCC) (cytokine pretreated) were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    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
    		 Pazopanib 800 mg
    Arm description
    		 Pazopanib 800 mg (tablets) administered orally once a day
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg (2 x 400 mg tablets) once daily. 200 and 400 mg tablets were available to sites, to allow for dose modifications (typically 600 mg).

    Arm title
    		 Placebo
    Arm description
    		 Matching Placebo administered orally once a day
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg (2 x 400 mg placebo tablets) once daily. 200 and 400 mg tablets were available to sites, to allow for dose modifications (typically 600 mg).

    Number of subjects in period 1
    		Pazopanib 800 mg Placebo
    Started
    290
    145
    Completed
    68
    37
    Not completed
    222
    108
         Consent withdrawn by subject
    17
    3
         Death
    194
    100
         Lost to follow-up
    11
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pazopanib 800 mg
    Reporting group description
    		 Pazopanib 800 mg (tablets) administered orally once a day

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo administered orally once a day

    Reporting group values
    		 Pazopanib 800 mg Placebo Total
    Number of subjects
    		 290 145 435
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.1 ( 10.06 ) 59.6 ( 11.04 ) -
    Gender categorical
    Units: Subjects
        Female
    		 92 36 128
        Male
    		 198 109 307
    Race, Customized
    Units: Subjects
        White
    		 252 122 374
        Asian
    		 36 23 59
        African American/African Heritage
    		 1 0 1
        Native Hawaiian or other Pacific Islander
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Pazopanib 800 mg
    Reporting group description
    		 Pazopanib 800 mg (tablets) administered orally once a day

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo administered orally once a day

    Primary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.
    End point type
    Primary
    End point timeframe
    Randomization until progression (up to 2 years)
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    290 [1]
    145 [2]
    Units: months
        median (confidence interval 95%)
    9.2 (7.4 to 12.9)
    4.2 (2.8 to 5.6)
    Notes
    [1] - Intent-to-Treat (ITT) Population: all randomized participants
    [2] - Intent-to-Treat (ITT) Population: all randomized participants
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Pazopanib 800 mg v Placebo
    Number of subjects included in analysis
    435
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 1E-7 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 0.62
    Notes
    [3] - The estimated value is the hazard ratio comparing pazopanib to placebo.
    [4] - stratified log-rank test

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.
    End point type
    Secondary
    End point timeframe
    Randomization until death (up to 2 years)
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    290 [5]
    145 [6]
    Units: Months
        median (confidence interval 95%)
    22.9 (19.9 to 25.4)
    20.5 (15.6 to 27.6)
    Notes
    [5] - ITT Population
    [6] - ITT Population
    No statistical analyses for this end point

    Secondary: Overall Response

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    End point title
    		 Overall Response
    End point description
    Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.
    End point type
    Secondary
    End point timeframe
    Baseline until either response or progression (up to 2 years)
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    290 [7]
    145 [8]
    Units: participants
        Complete Response, IRC assessed
    1
    0
        Partial Response, IRC assessed
    87
    5
        Stable Disease, IRC assessed
    110
    59
        Progressive Disease, IRC assessed
    51
    58
        Unknown, IRC assessed
    41
    23
        Complete Response, Investigator assessed
    4
    0
        Partial Response, Investigator assessed
    99
    9
        Stable Disease, Investigator assessed
    118
    62
        Progressive Disease, Investigator assessed
    46
    65
        Unknown, Investigator assessed
    23
    9
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Participants with complete response, partial response, or 6 months of stable disease

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    End point title
    		 Participants with complete response, partial response, or 6 months of stable disease
    End point description
    This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a >=20% increase in target lesions. IRC, independent review committee.
    End point type
    Secondary
    End point timeframe
    Baseline until 6 months post-Baseline or progressive disease
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    290 [9]
    145 [10]
    Units: participants
        Complete Response, IRC assessed
    1
    0
        Partial Response, IRC assessed
    87
    5
        6-months Stable Disease, IRC assessed
    48
    17
        Progressive Disease, IRC assessed
    92
    84
        Unknown, IRC assessed
    62
    39
    Notes
    [9] - ITT Population
    [10] - ITT Population
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    		 Duration of response [11]
    End point description
    Duration of response is defined as the time from first observation of response until progression of disease or death.
    End point type
    Secondary
    End point timeframe
    Time from response until progression (up to 2 years)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There are no statistical data to report.
    End point values
    		 Pazopanib 800 mg
    Number of subjects analysed
    290 [12]
    Units: weeks
        median (confidence interval 95%)
    58.7 (52.1 to 68.1)
    Notes
    [12] - ITT Population. Only results for pazopanib are given because there were too few placebo responders.
    No statistical analyses for this end point

    Secondary: Time to response as assessed by an Independent Review Committee (IRC) and the Investigator

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    End point title
    		 Time to response as assessed by an Independent Review Committee (IRC) and the Investigator [13]
    End point description
    Time to response is defined as the time from randomization until the first documented evidence of complete reponse (all detectable tumor has disappeared) or partial response (a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first). Only results for pazopanib are given because there were not enough placebo responders. The different number of participants analyzed is due to differences in clinical judgement, measurement, and the selection of target lesions.
    End point type
    Secondary
    End point timeframe
    Randomization until CR or PR (assessed for up to 2 years)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There are no statistical data to report.
    End point values
    		 Pazopanib 800 mg
    Number of subjects analysed
    103 [14]
    Units: weeks
    median (confidence interval 95%)
        IRC assessed, n=88
    11.9 (9.4 to 12.3)
        Investigator assessed, n=103
    12 (11.6 to 12.3)
    Notes
    [14] - ITT Population. Only participants with a complete or partial response were analyzed.
    No statistical analyses for this end point

    Secondary: Adjusted Mean change from Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) score at Weeks 6, 12, 18, 24, and 48

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    End point title
    		 Adjusted Mean change from Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) score at Weeks 6, 12, 18, 24, and 48
    End point description
    The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 [very poor quality of life] to 7 [excellent quality of life]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 6, 12, 18, 24, and 48
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    246 [15]
    111 [16]
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 6, n=243, 110
    -3.2 ( 19.66 )
    -2.6 ( 19.18 )
        Week 12, n=219, 81
    -3.6 ( 20.16 )
    -0.5 ( 17.55 )
        Week 18, n=191, 61
    -2.5 ( 21.7 )
    -0.3 ( 18.13 )
        Week 24, n=164, 49
    0.1 ( 19.81 )
    -0.5 ( 18.67 )
        Week 48, n=96, 24
    -0.3 ( 18.36 )
    0.3 ( 15.63 )
    Notes
    [15] - ITT Population participants who completed HRQOL assessments at BL and had >=1 post-BL assessment
    [16] - ITT Population participants who completed HRQOL assessments at BL and had >=1 post-BL assessment
    No statistical analyses for this end point

    Secondary: Adjusted Mean change from Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48

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    End point title
    		 Adjusted Mean change from Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
    End point description
    The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (<0). Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 6, 12, 18, 24, and 48
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    253 [17]
    125 [18]
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 6, n=253, 125
    -0.014 ( 0.2203 )
    -0.029 ( 0.2674 )
        Week 12, n=219, 86
    -0.04 ( 0.2148 )
    0.007 ( 0.1969 )
        Week 18, n=196, 62
    -0.023 ( 0.2305 )
    -0.006 ( 0.1466 )
        Week 24, n=166, 51
    -0.025 ( 0.242 )
    -0.001 ( 0.2411 )
        Week 36, n=98, 24
    0.03 ( 0.1961 )
    -0.005 ( 0.2015 )
    Notes
    [17] - ITT Population participants who completed HRQOL assessments at BL and had >=1 post-BL assessment
    [18] - ITT Population participants who completed HRQOL assessments at BL and had >=1 post-BL assessment
    No statistical analyses for this end point

    Secondary: Adjusted Mean change from Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48

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    End point title
    		 Adjusted Mean change from Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
    End point description
    The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant’s self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state). Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 6, 12, 18, 24, and 48
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    239 [19]
    111 [20]
    Units: points on a scale
    arithmetic mean (standard deviation)
        Week 6, n=239, 111
    -0.9 ( 21.07 )
    -3.6 ( 23.04 )
        Week 12, n=212, 80
    0.4 ( 22.55 )
    0.2 ( 25.35 )
        Week 18, n=189, 60
    0.1 ( 23.2 )
    0.1 ( 19.35 )
        Week 24, n=161, 49
    2.6 ( 22.16 )
    5.4 ( 21.27 )
        Week 36, n=95, 23
    2.4 ( 24.21 )
    8.8 ( 23.96 )
    Notes
    [19] - ITT Population participants who completed HRQOL assessments at BL and had >=1 post-BL assessment
    [20] - ITT Population participants who completed HRQOL assessments at BL and had >=1 post-BL assessment
    No statistical analyses for this end point

    Secondary: Plasma pazopanib concentrations before dosing and at 2, 4, and 8 hours after dosing on Day 1 and Week 3

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    End point title
    		 Plasma pazopanib concentrations before dosing and at 2, 4, and 8 hours after dosing on Day 1 and Week 3 [21]
    End point description
    Subgroup of enrolled participants who agreed to have blood samples collected for analysis of pazopanib in plasma. Data were missing or not collected at Week 3 for 8 participants for whom data were available on Day 1. No samples were collected at Week 3 from 2 participants.
    End point type
    Secondary
    End point timeframe
    Day 1 and Week 3
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There are no statistical data to report.
    End point values
    		 Pazopanib 800 mg
    Number of subjects analysed
    57 [22]
    Units: nanograms per milliliter
    median (full range (min-max))
        Day 1, before dosing, n=57
    0 (0 to 846)
        Week 3, before dosing, n=48
    31851 (2634 to 61720)
        Day 1, 2 hours after dosing, n=57
    17270 (0 to 107454)
        Week 3, 2 hours after dosing, n=49
    42205 (4282 to 79977)
        Day 1, 4 hours after dosing, n=57
    24360 (2371 to 74606)
        Week 3, 4 hours after dosing, n=49
    42637 (3532 to 107972)
        Day 1, 8 hours after dosing, n=57
    19925 (3273 to 60974)
        Week 3, 8 hours after dosing, n=48
    40117.5 (3760 to 96548)
    Notes
    [22] - Enrolled participants who agreed to have blood samples collected for analysis of pazopanib in plasma
    No statistical analyses for this end point

    Secondary: Baseline expression levels of the indicated target proteins in pazopanib- and placebo-treated participants

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    End point title
    		 Baseline expression levels of the indicated target proteins in pazopanib- and placebo-treated participants
    End point description
    Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Pazopanib 800 mg Placebo
    Number of subjects analysed
    225 [23]
    119 [24]
    Units: picograms per milliliter
    arithmetic mean (standard deviation)
        Interleukin-6
    31.003 ( 65.247 )
    24.145 ( 31.708 )
        Interleukin-8
    35.429 ( 164.12 )
    27.755 ( 66.129 )
        Vascular endothelial growth factor
    308.61 ( 365.19 )
    273.15 ( 350.91 )
        Hepatocyte growth factor
    383.55 ( 308.89 )
    522.94 ( 1003.8 )
        Tissue inhibitor of metalloproteinase 1
    847464 ( 690744 )
    735915 ( 423493 )
        e-Selectin
    41649.28 ( 22389.04 )
    41231.45 ( 19825.7 )
        Osteopotin
    444343 ( 707005 )
    369317 ( 490931 )
    Notes
    [23] - Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses
    [24] - Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Pazopanib 800 mg
    Reporting group description
    		 Pazopanib 800 mg (tablets) administered orally once a day

    Reporting group title
    Placebo
    Reporting group description
    		 Matching Placebo administered orally once a day

    Serious adverse events
    		 Pazopanib 800 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    79 / 290 (27.24%)
    28 / 145 (19.31%)
         number of deaths (all causes)
    14
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chest pain
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cough
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 290 (2.07%)
    3 / 145 (2.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    4 / 290 (1.38%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 290 (1.03%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotranserase increased
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urea increased
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin graft failure
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    3 / 290 (1.03%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 290 (2.07%)
    4 / 145 (2.76%)
         occurrences causally related to treatment / all
    7 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    6 / 290 (2.07%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    5 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 290 (1.38%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorectal varices haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    3 / 290 (1.03%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myelitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 290 (0.69%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pazopanib 800 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    258 / 290 (88.97%)
    87 / 145 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    115 / 290 (39.66%)
    16 / 145 (11.03%)
         occurrences all number
    146
    21
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    44 / 290 (15.17%)
    13 / 145 (8.97%)
         occurrences all number
    62
    14
    Chest pain
         subjects affected / exposed
    16 / 290 (5.52%)
    2 / 145 (1.38%)
         occurrences all number
    18
    2
    Fatigue
         subjects affected / exposed
    58 / 290 (20.00%)
    13 / 145 (8.97%)
         occurrences all number
    78
    14
    Pyrexia
         subjects affected / exposed
    14 / 290 (4.83%)
    9 / 145 (6.21%)
         occurrences all number
    17
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    25 / 290 (8.62%)
    14 / 145 (9.66%)
         occurrences all number
    34
    14
    Dyspnoea
         subjects affected / exposed
    19 / 290 (6.55%)
    8 / 145 (5.52%)
         occurrences all number
    20
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    16 / 290 (5.52%)
    10 / 145 (6.90%)
         occurrences all number
    17
    11
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    54 / 290 (18.62%)
    4 / 145 (2.76%)
         occurrences all number
    90
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    46 / 290 (15.86%)
    5 / 145 (3.45%)
         occurrences all number
    77
    5
    Weight decreased
         subjects affected / exposed
    31 / 290 (10.69%)
    6 / 145 (4.14%)
         occurrences all number
    44
    6
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    25 / 290 (8.62%)
    1 / 145 (0.69%)
         occurrences all number
    30
    1
    Headache
         subjects affected / exposed
    31 / 290 (10.69%)
    8 / 145 (5.52%)
         occurrences all number
    49
    15
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    19 / 290 (6.55%)
    7 / 145 (4.83%)
         occurrences all number
    19
    11
    Neutropenia
         subjects affected / exposed
    15 / 290 (5.17%)
    0 / 145 (0.00%)
         occurrences all number
    22
    0
    Thrombocytopenia
         subjects affected / exposed
    22 / 290 (7.59%)
    2 / 145 (1.38%)
         occurrences all number
    26
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    32 / 290 (11.03%)
    2 / 145 (1.38%)
         occurrences all number
    52
    2
    Abdominal pain upper
         subjects affected / exposed
    24 / 290 (8.28%)
    8 / 145 (5.52%)
         occurrences all number
    28
    13
    Constipation
         subjects affected / exposed
    20 / 290 (6.90%)
    9 / 145 (6.21%)
         occurrences all number
    24
    9
    Diarrhoea
         subjects affected / exposed
    149 / 290 (51.38%)
    13 / 145 (8.97%)
         occurrences all number
    321
    15
    Dyspepsia
         subjects affected / exposed
    16 / 290 (5.52%)
    1 / 145 (0.69%)
         occurrences all number
    18
    1
    Nausea
         subjects affected / exposed
    75 / 290 (25.86%)
    13 / 145 (8.97%)
         occurrences all number
    98
    16
    Vomiting
         subjects affected / exposed
    59 / 290 (20.34%)
    12 / 145 (8.28%)
         occurrences all number
    122
    13
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    24 / 290 (8.28%)
    1 / 145 (0.69%)
         occurrences all number
    25
    1
    Hair colour changes
         subjects affected / exposed
    109 / 290 (37.59%)
    5 / 145 (3.45%)
         occurrences all number
    111
    5
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    17 / 290 (5.86%)
    1 / 145 (0.69%)
         occurrences all number
    20
    1
    Rash
         subjects affected / exposed
    24 / 290 (8.28%)
    4 / 145 (2.76%)
         occurrences all number
    31
    6
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    30 / 290 (10.34%)
    0 / 145 (0.00%)
         occurrences all number
    47
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    20 / 290 (6.90%)
    0 / 145 (0.00%)
         occurrences all number
    22
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    25 / 290 (8.62%)
    14 / 145 (9.66%)
         occurrences all number
    32
    15
    Back pain
         subjects affected / exposed
    23 / 290 (7.93%)
    17 / 145 (11.72%)
         occurrences all number
    27
    30
    Pain in extremity
         subjects affected / exposed
    20 / 290 (6.90%)
    9 / 145 (6.21%)
         occurrences all number
    24
    11
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    70 / 290 (24.14%)
    17 / 145 (11.72%)
         occurrences all number
    93
    17

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2006
    Am 01: To clarify determination on objective disease progression and to provide other minor clarifications to the protocol.
    22 Mar 2006
    Am 02: Minor changes in clinical visit schedules and other minor clarifications to the protocol.
    09 May 2006
    Am 03: Major changes include: expansion of subject population, inclusion of pazopanib as a post-progression treatment option, revisions to the interim analysis.
    07 Aug 2006
    Am 04: Revision in inclusion criteria #5 for subject population
    23 May 2007
    Am 05: Addition of new medical monitors for the study. Update on pazopanib safety and efficacy. Addition of detailed instruction for dose modification for liver toxicity and minor revision on sensitivity analysis.
    01 May 2012
    Am 06: Study has reported primary and key secondary objectives. Discontinue collection of many study-specific assessments while allowing subjects on treatment with pazopanib to have continued access until occurrence of unacceptable toxicity, disease progression, or other reason for withdrawal from treatment. Data collected will include serious adverse events, pregnancies, adverse events (AEs) leading to discontinuation of investigational product, and other significant AEs.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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