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Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma (COMPARZ)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00720941
First received: July 22, 2008
Last updated: June 19, 2014
Last verified: February 2014
Results First Received: January 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Interventions: Drug: Pazopanib
Drug: Sunitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Per protocol amendment, the number of participants (par.) was increased to ~1100 (including all par. enrolled in Studies VEG108844 and VEG113078 [NCT01147822; a substudy in Asian par.]). This summary is a pooled analysis of both studies. 1110 par. were analyzed; 927 from VEG108844 (reflected in the protocol enrollment field), 183 from VEG113078.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were stratified based on Karnofsky Performance Scale scores (70 or 80; 90 or 100), Baseline levels of lactate dehydrogenase (>1.5 versus <=1.5 times the upper limit of normal [ULN]), and previous nephrectomy (yes versus no) and were randomized in a 1:1 ratio to receive either pazopanib or sunitinib.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Participant Flow:   Overall Study
    Pazopanib 800 mg     Sunitinib 50 mg  
STARTED     557     553  
Ongoing     34     23  
COMPLETED     144     138  
NOT COMPLETED     413     415  
Death                 334                 335  
Protocol Violation                 0                 2  
Lost to Follow-up                 17                 15  
Physician Decision                 1                 5  
Withdrawal by Subject                 27                 35  
Ongoing                 34                 23  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Total Total of all reporting groups

Baseline Measures
    Pazopanib 800 mg     Sunitinib 50 mg     Total  
Number of Participants  
[units: participants]
  557     553     1110  
Age  
[units: Years]
Mean ± Standard Deviation
  60.9  ± 10.89     61.2  ± 10.98     61.1  ± 10.93  
Gender  
[units: Participants]
     
Female     159     138     297  
Male     398     415     813  
Race/Ethnicity, Customized  
[units: Participants]
     
African American/African Heritage     10     5     15  
American Indian or Alaska Native     3     0     3  
Asian     194     188     382  
White     349     358     707  
American Indian or Alaska Native & White     0     1     1  
Unknown     1     1     2  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization until the earliest date of disease progression or death (up to Study Week 191) ]

Measure Type Primary
Measure Title Progression-free Survival (PFS)
Measure Description PFS is defined as the interval between the date of randomization and the earliest date of progressive disease (PD), as defined by the Independent Review Committee (IRC), or death due to any cause. The IRC defined PD per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1. Per RECIST, PD is defined as a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion. The Kaplan-Meier method was used for PFS estimates.
Time Frame From randomization until the earliest date of disease progression or death (up to Study Week 191)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Population: all participants randomized to receive treatment. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Participants who had neither progressed nor died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  557     553  
Progression-free Survival (PFS)  
[units: Months]
Median ( 95% Confidence Interval )
  8.4  
  ( 8.3 to 10.9 )  
  9.5  
  ( 8.3 to 11.1 )  


Statistical Analysis 1 for Progression-free Survival (PFS)
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Hazard Ratio (HR) [3] 1.0466
95% Confidence Interval ( 0.8982 to 1.2195 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be <1.25.
[3] Other relevant estimation information:
  The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (<=1.5xULN, >1.5xULN).



2.  Secondary:   Overall Survival   [ Time Frame: From randomization until death (up to Study Week 268) ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Overall survival is defined as the time from randomization until death due to any cause.
Time Frame From randomization until death (up to Study Week 268)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  557     553  
Overall Survival  
[units: Months]
Median ( 95% Confidence Interval )
  28.3  
  ( 26.0 to 35.5 )  
  29.1  
  ( 25.4 to 33.1 )  

No statistical analysis provided for Overall Survival



3.  Secondary:   Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review   [ Time Frame: From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167) ]

Measure Type Secondary
Measure Title Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review
Measure Description The number of participants with evidence of CR (the disappearance of all target and non-target lesions), PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD), Stable Disease (small changes that do not meet previously given criteria), or Progressive Disease (a >=20% increase in target lesions within the first 12 weeks of treatment) was evaluated by an independent review per RECIST, Version 1.
Time Frame From randomization until the time of a confirmed best response of CR or PR (up to Study Week 167)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  557     553  
Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review  
[units: Participants]
   
CR     1     3  
PR     170     134  
Stable Disease     216     242  
Progressive Disease     97     105  
Unknown     73     69  

No statistical analysis provided for Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review



4.  Secondary:   Time to Response   [ Time Frame: From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167) ]

Measure Type Secondary
Measure Title Time to Response
Measure Description Time to response is defined as the time from the start of treatment until the first documented evidence of CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD), whichever comes first. CR and PR were evaluated by an independent review per RECIST, Version 1.
Time Frame From randomization until the time of the first documented confirmed complete or partial response (up to Study Week 167)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  171     137  
Time to Response  
[units: Weeks]
Median ( 95% Confidence Interval )
  11.9  
  ( 11.3 to 12.1 )  
  17.4  
  ( 12.7 to 18.0 )  

No statistical analysis provided for Time to Response



5.  Secondary:   Duration of Response (DOR)   [ Time Frame: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167) ]

Measure Type Secondary
Measure Title Duration of Response (DOR)
Measure Description DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD.
Time Frame From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (up to Study Week 167)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  171     137  
Duration of Response (DOR)  
[units: Months]
Median ( 95% Confidence Interval )
  13.8  
  ( 12.2 to 16.4 )  
  18.0  
  ( 14.3 to 22.1 )  

No statistical analysis provided for Duration of Response (DOR)



6.  Secondary:   Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)   [ Time Frame: From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268) ]

Measure Type Secondary
Measure Title Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)
Measure Description See the SAE/AE module for a list of all SAEs/AEs. SAE=any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, a congenital anomaly/birth defect, or a Grade 4 laboratory abnormality. Events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment.
Time Frame From the time of the first dose of study drug to approximately one month after the discontinuation of study drug (up to Study Week 268)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  554     548  
Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)  
[units: Participants]
   
Any SAE     234     233  
Any AE     552     544  

No statistical analysis provided for Number of Participants (Par.) With Serious Adverse Events (SAEs)/Non-serious Adverse Events (Any Untoward Medical Occurrence in a Par. Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With This Treatment)



7.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline (predose); Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The FACIT-F scale measures the severity and impact of fatigue on functioning and health related quality of life (HRQoL) experienced in the past seven days. The level of fatigue is measured by 13 questions assessed on a four-point scale (0=not at all fatigued; 1=a little bit fatigued; 2=somewhat fatigued; 3=quite a bit fatigued; 4=very much fatigued; possible total score of 0 to 52). A negative change from Baseline represents a worsening condition. Change from Baseline was calculated as the assessment week value minus the Baseline value.
Time Frame Baseline (predose); Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at some of the other early time points were excluded from the analysis at those time points.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  353     375  
Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=353, 375     -5.3  ± 11.00     -6.7  ± 10.93  
Week 10, n=293, 330     -4.0  ± 10.28     -6.3  ± 10.65  
Week 16, n=273, 280     -3.8  ± 10.13     -6.9  ± 11.16  
Week 22, n=227, 240     -2.9  ± 9.77     -6.5  ± 10.51  

No statistical analysis provided for Change From Baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) Scale Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



8.  Secondary:   Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-P domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to 12 questions ("I have a lack of energy," "I feel pain," for example) by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 48). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  358     378  
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=358, 378     -2.9  ± 6.39     -3.9  ± 6.87  
Week 10, n=296, 336     -2.3  ± 6.69     -3.2  ± 6.76  
Week 16, n=269, 283     -2.6  ± 6.70     -3.2  ± 6.61  
Week 22, n=224, 238     -1.3  ± 6.29     -2.7  ± 6.42  

No statistical analysis provided for Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease-related Symptoms-physical (DRS-P) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



9.  Secondary:   Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The FKSI-19 is a disease-specific instrument measuring disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The DRS-E domain assesses symptoms experienced in the past 7 days. Participants are asked to respond to the question of "I worry that my condition will get worse" by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 4). A negative change from Baseline (BL) represents a worsening of condition. Change from BL was calculated as the assessment week value minus the BL value.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  344     367  
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=344, 367     0.3  ± 1.31     0.4  ± 1.22  
Week 10, n=287, 329     0.4  ± 1.33     0.5  ± 1.32  
Week 16, n=260, 277     0.5  ± 1.39     0.6  ± 1.30  
Week 22, n=220, 233     0.6  ± 1.27     0.6  ± 1.20  

No statistical analysis provided for Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Disease Related Symptoms-emotional (DRS-E) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



10.  Secondary:   Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The TSE domain assesses side effects experienced in the past 7 days. Participants are asked to respond to 3 questions ("I have nausea," "I have diarrhea," and "I am bothered by side effects of treatment") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12).Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  326     350  
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=326, 350     -1.5  ± 2.45     -2.0  ± 2.35  
Week 10, n=267, 305     -1.9  ± 2.66     -2.4  ± 2.62  
Week 16, n=244, 254     -2.1  ± 2.79     -2.8  ± 2.46  
Week 22, n=201, 218     -2.4  ± 2.75     -2.4  ± 2.33  

No statistical analysis provided for Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



11.  Secondary:   Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains. The FWB domain assesses well being in the past 7 days. Participants are asked to respond to 3 questions ("I am able to work," "I am able to enjoy life," and "I am content with the quality of my life now") by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total domain score of 0 to 12). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  357     378  
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=357, 378     -1.0  ± 4.01     -1.3  ± 3.63  
Week 10, n=298, 331     -0.6  ± 4.00     -1.1  ± 3.94  
Week 16, n=267, 278     -0.8  ± 4.08     -1.0  ± 3.96  
Week 22, n=228, 234     -0.7  ± 3.93     -1.0  ± 3.82  

No statistical analysis provided for Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Functional Well Being (FWB) Domain Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



12.  Secondary:   Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (DRS-P, DRS-E, TSE, and FWB). Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  358     379  
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=358, 379     -5.0  ± 10.82     -6.6  ± 10.55  
Week 10, n=296, 337     -4.2  ± 10.95     -6.3  ± 11.21  
Week 16, n=267, 284     -4.8  ± 11.13     -6.3  ± 10.67  
Week 22, n=225, 238     -3.7  ± 10.49     -5.5  ± 10.13  

No statistical analysis provided for Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Total Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



13.  Secondary:   Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The SQLQ scale consists of 5 items that assess the worst mouth and throat, hand, and foot soreness, as well as limitations due to mouth/throat and foot soreness. Participants were asked to assess their worst mouth/throat, hand, and foot soreness by answering the question of " In the past 4 weeks, what was your worst mouth/throat, hand, and foot soreness?" by using the following 4-point scale: 0, I never had any soreness; 1, I had a little bit of soreness; 2, I had quite a lot of soreness; 3, I had severe soreness. A positive mean change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  202     184  
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Mouth and Throat Soreness, Week 4, n=202, 180     0.4  ± 0.87     1.0  ± 0.99  
Mouth and Throat Soreness, Week 10, n=164, 155     0.4  ± 0.88     0.9  ± 0.99  
Mouth and Throat Soreness, Week 16, n=137, 138     0.3  ± 0.73     0.8  ± 0.89  
Mouth and Throat Soreness, Week 22, n=120, 117     0.2  ± 0.75     0.8  ± 0.81  
Hand Soreness, Week 4, n=200, 184     0.2  ± 0.71     0.3  ± 0.72  
Hand Soreness, Week 10, n=164, 153     0.3  ± 0.84     0.7  ± 0.85  
Hand Soreness, Week 16, n=139, 136     0.4  ± 0.76     0.6  ± 0.80  
Hand Soreness, Week 22, n=123, 115     0.3  ± 0.69     0.6  ± 0.82  
Foot Soreness, Week 4, n=199, 182     0.2  ± 0.86     0.4  ± 0.80  
Foot Soreness, Week 10, n=163, 153     0.3  ± 1.00     0.6  ± 0.99  
Foot Soreness, Week 16, n=140, 136     0.3  ± 1.07     0.8  ± 0.99  
Foot Soreness, Week 22, n=123, 116     0.3  ± 1.04     0.9  ± 0.96  

No statistical analysis provided for Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Scale Worst Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



14.  Secondary:   Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Participants (par.) assessed the limitations caused by their mouth/throat soreness by answering the question of "In the past 4 weeks, how much did your worst mouth/throat soreness limit you in the following activities: swallowing/eating/drinking/talking/sleeping" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  177     170  
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=177, 170     -0.9  ± 2.09     -1.8  ± 2.91  
Week 10, n=144, 137     -0.9  ± 1.91     -1.8  ± 3.06  
Week 16, 125, 122     -0.6  ± 1.56     -1.3  ± 2.30  
Week 22, n=111, 107     -0.4  ± 1.67     -1.4  ± 1.85  

No statistical analysis provided for Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Mouth and Throat Soreness Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



15.  Secondary:   Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Baseline; Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The SQLQ consists of 5 items assessing the worst mouth/throat, hand, and foot soreness, and limitations due to mouth/throat and foot soreness. Par. assessed the limitations caused by their foot soreness by answering the question of "In the past 4 weeks, how much did your worst foot soreness limit you in each of the following activities: standing/walking/climbing stairs/sleeping/ability to do usual activities" by using the following 4-point scale: 0, not limited; 1, limited a little; 2, limited a lot; 3, unable to do. The overall limitation score (15=best; 0=worst), based on the individual scores for the 5 activities, is derived as follows: the actual scores were rescored by subtracting the actual score from "3" for each of the 5 categories. A high score indicates less limitation. Change from Baseline was calculated as the assessment week value minus the Baseline value. A negative mean change from Baseline represents a worsening of condition.
Time Frame Baseline; Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  170     163  
Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
Week 4, n=170, 163     -0.6  ± 2.94     -1.0  ± 2.94  
Week 10, n=133, 136     -1.1  ± 3.02     -1.5  ± 3.76  
Week 16, n=114, 126     -1.2  ± 3.42     -2.2  ± 3.50  
Week 22, n=105, 108     -1.3  ± 3.25     -2.1  ± 3.52  

No statistical analysis provided for Change From Baseline in the Supplementary Quality of Life Questions (SQLQ) Limitations Due to Foot Soreness Scores at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



16.  Secondary:   Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The CTSQ assesses 3 domains related to the participant’s satisfaction with cancer therapy: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Participants shared their thoughts on their cancer therapy (9 questions), their satisfaction with their most recently administered cancer therapy (6 questions), and if they would take the same cancer therapy if given the choice to do so again. All questions were assessed on a 5-point scale; 1, never; 5, always. Scores were averaged and transformed to a 0-100 scale; higher scores represent better health.
Time Frame Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Participants missing scores at early time points were excluded from the analysis at those time points. Mean total score was calculated at each assessment week.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  383     386  
Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: Scores on a scale]
Mean ± Standard Deviation
   
ET, Week 4, n=383, 386     71.7  ± 22.13     71.3  ± 22.38  
ET, Week 10, n=321, 346     73.4  ± 21.62     73.4  ± 19.37  
ET, Week 16, n=296, 293     73.9  ± 21.56     72.9  ± 21.43  
ET, Week 22, n=250, 250     73.0  ± 21.40     73.4  ± 20.43  
FSE, Week 4, n=340, 360     66.3  ± 24.00     58.5  ± 23.59  
FSE, Week 10, n=298, 323     66.0  ± 23.09     56.0  ± 22.23  
FSE, Week 16, n=274, 277     65.0  ± 23.01     56.6  ± 22.02  
FSE, Week 22, n=235, 232     67.1  ± 22.62     57.8  ± 21.28  
SWT, Week 4, n=355, 374     80.9  ± 15.49     79.0  ± 15.23  
SWT, Week 10, n=309, 336     84.5  ± 13.74     80.4  ± 15.15  
SWT, Week 16, n=287, 284     85.3  ± 14.77     80.5  ± 15.08  
SWT, Week 22, n=241, 240     85.4  ± 13.48     81.4  ± 15.01  

No statistical analysis provided for Summary of Analysis for the Cancer Treatment Satisfaction Questionnaire (CTSQ) Score at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)



17.  Secondary:   Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24   [ Time Frame: From Day 1 up to Week 24 ]

Measure Type Secondary
Measure Title Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24
Measure Description Non-study medical visits were defined as the sum of primary care physician visits, nurse practitioner/physician’s assistant/nurse visits, and medical or surgical specialist visits. Days hospitalized were defined as the sum of days in the general ward and days in intensive care. The number of telephone consultations and ER visits was assessed via individual questions on the electronic Case Report Form. The endpoint was totaled through Week 24, divided by the number of days on treatment for each participant, then multiplied by 30 days to get the number of visits per 30 days.
Time Frame From Day 1 up to Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  429     432  
Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24  
[units: events per 30 days]
Mean ± Standard Deviation
   
Non-Study Medical Visits     0.726  ± 1.472     0.779  ± 1.690  
Telephone Consultations     0.279  ± 0.718     0.312  ± 0.656  
Hospital Days     0.402  ± 2.273     0.562  ± 2.187  
ER Visits     0.037  ± 0.156     0.067  ± 0.195  

No statistical analysis provided for Medical Resource Utilization (MRU): Assessed as the Mean Number of Non-study Medical Visits, Telephone Consultations, Hospital Days, and Emergency Room (ER) Visits Per 30 Days Through Week 24



18.  Secondary:   MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)   [ Time Frame: Weeks 4, 10, 16, and 22 ]

Measure Type Secondary
Measure Title MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)
Measure Description The number of non-study laboratory visits (NSLVs), non-study radiology visits (NSRVs), and home healthcare visits (HHVs) were each collected as a single question on the eCRF. The number of non-study medical or surgical procedures (MSPs) was defined as the sum of procedures performed at outpatient or physician clinics, as well as those performed during any inpatient hospitalization.
Time Frame Weeks 4, 10, 16, and 22  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.

Reporting Groups
  Description
Pazopanib 800 mg Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Measured Values
    Pazopanib 800 mg     Sunitinib 50 mg  
Number of Participants Analyzed  
[units: participants]
  419     414  
MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)  
[units: visits]
Mean ± Standard Deviation
   
NSLVs, Week 4, n= 417, 414     0.3  ± 1.25     0.3  ± 1.14  
NSLVs, Week 10, n= 345, 363     0.3  ± 0.97     0.4  ± 1.35  
NSLVs, Week 16, n= 299, 304     0.2  ± 0.67     0.2  ± 0.58  
NSLVs, Week 22, n= 265, 254     0.1  ± 0.49     0.1  ± 0.47  
NSRVs, Week 4, n= 419, 414     0.1  ± 0.44     0.1  ± 0.56  
NSRVs, Week 10, n= 348, 364     0.1  ± 0.36     0.1  ± 0.88  
NSRVs, Week 16, n= 299, 305     0.0  ± 0.28     0.1  ± 0.33  
NSRVs, Week 22, n= 266, 255     0.0  ± 0.24     0.1  ± 0.46  
HHVs, Week 4, n= 418, 411     0.0  ± 0.44     0.1  ± 0.77  
HHVs, Week 10, n= 343, 363     0.1  ± 0.52     0.1  ± 0.64  
HHVs, Week 16, n= 298, 304     0.1  ± 0.72     0.0  ± 0.37  
HHVs, Week 22, n= 265, 254     0.0  ± 0.49     0.1  ± 1.77  
MSPs, Week 4, n= 417, 413     0.2  ± 0.69     0.3  ± 2.52  
MSPs, Week 10, n= 344, 363     0.2  ± 0.68     0.2  ± 1.17  
MSPs, Week 16, n= 298, 304     0.2  ± 0.60     0.3  ± 1.98  
MSPs, Week 22, n= 266, 254     0.2  ± 0.85     0.3  ± 1.73  

No statistical analysis provided for MRU: The Mean Number of Laboratory Visits, Radiology Visits, Home Healthcare Visits, and Medical Procedures for Cycles 1-4. MRU Data Collected at Day 28 of Cycles 1-4 (Average of Weeks 4, 10, 16, and 22, Respectively)




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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