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

• ClinicalTrials.gov Identifier: NCT00720941
• Recruitment Status: Completed
• First Posted: July 23, 2008
• Results First Posted: June 17, 2013
• Last Update Posted: May 13, 2021
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Renal Cell
• Interventions: Drug: Pazopanib; Drug: Sunitinib
• Enrollment: 927

Participant Flow

Recruitment Details	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	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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	557	553
Ongoing	34	23
Completed	144	138
Not Completed	413	415
Reason Not Completed
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

Arm/Group Title		Pazopanib 800 mg	Sunitinib 50 mg	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		557	553	1110
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	557 participants	553 participants	1110 participants
		60.9 (10.89)	61.2 (10.98)	61.1 (10.93)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	557 participants	553 participants	1110 participants
	Female	159 28.5%	138 25.0%	297 26.8%
	Male	398 71.5%	415 75.0%	813 73.2%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	557 participants	553 participants	1110 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

1. Primary Outcome

Title	Progression-free Survival (PFS)
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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	557	553
Median (95% Confidence Interval); Unit of Measure: Months
	8.4; (8.3 to 10.9)	9.5; (8.3 to 11.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pazopanib 800 mg, Sunitinib 50 mg
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	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.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.0466
	Confidence Interval	(2-Sided) 95%; 0.8982 to 1.2195
	Estimation Comments	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 Outcome

Title	Overall Survival
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)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	557	553
Median (95% Confidence Interval); Unit of Measure: Months
	28.3; (26.0 to 35.5)	29.1; (25.4 to 33.1)

3. Secondary Outcome

Title	Number of Participants in the Indicated Categories for Overall Response as Assessed by Independent Review
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)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	557	553
Measure Type: Number; Unit of Measure: Participants
CR	1	3
PR	170	134
Stable Disease	216	242
Progressive Disease	97	105
Unknown	73	69

4. Secondary Outcome

Title	Time to Response
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)

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants who experienced either a confirmed CR or a PR were analyzed.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	171	137
Median (95% Confidence Interval); Unit of Measure: Weeks
	11.9; (11.3 to 12.1)	17.4; (12.7 to 18.0)

5. Secondary Outcome

Title	Duration of Response (DOR)
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)

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants who had either a confirmed CR or PR were analyzed.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	171	137
Median (95% Confidence Interval); Unit of Measure: Months
	13.8; (12.2 to 16.4)	18.0; (14.3 to 22.1)

6. Secondary Outcome

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)
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)

Outcome Measure Data

Analysis Population Description

Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	554	548
Measure Type: Number; Unit of Measure: Participants
Any SAE	234	233
Any AE	552	544

7. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:		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.	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.
Overall Number of Participants Analyzed		353	375
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Week 4, n=353, 375	Number Analyzed	353 participants	375 participants
		-5.3 (11.00)	-6.7 (10.93)
Week 10, n=293, 330	Number Analyzed	293 participants	330 participants
		-4.0 (10.28)	-6.3 (10.65)
Week 16, n=273, 280	Number Analyzed	273 participants	280 participants
		-3.8 (10.13)	-6.9 (11.16)
Week 22, n=227, 240	Number Analyzed	227 participants	240 participants
		-2.9 (9.77)	-6.5 (10.51)

8. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	358	378
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

9. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	344	367
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

10. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	326	350
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

11. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	357	378
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

12. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	358	379
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

13. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	202	184
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

14. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	177	170
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

15. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	170	163
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

16. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	383	386
Mean (Standard Deviation); Unit of Measure: Scores on a scale
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)

17. Secondary Outcome

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
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

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants who had non-study medical visits, telephone consulations, days in the hospital, and ER visits were analyzed.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	429	432
Mean (Standard Deviation); Unit of Measure: events per 30 days
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)

18. Secondary Outcome

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)
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

Outcome Measure Data

Analysis Population Description

ITT Population. Only those participants who had NSLVs, NSRVs, HHVs, and medical procedures were analyzed.

Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	419	414
Mean (Standard Deviation); Unit of Measure: visits
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)

Adverse Events

Time Frame	Participants were analyzed 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).
Adverse Event Reporting Description	Serious adverse events (SAEs) and non-serious AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication, according to the actual treatment received.
Arm/Group Title	Pazopanib 800 mg	Sunitinib 50 mg
Arm/Group Description	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.	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.
All-Cause Mortality
	Pazopanib 800 mg	Sunitinib 50 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Pazopanib 800 mg	Sunitinib 50 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	230/554 (41.52%)	224/548 (40.88%)
Blood and lymphatic system disorders
Anaemia † 1	9/554 (1.62%)	9/548 (1.64%)
Thrombocytopenia † 1	4/554 (0.72%)	25/548 (4.56%)
Febrile neutropenia † 1	3/554 (0.54%)	0/548 (0.00%)
Neutropenia † 1	2/554 (0.36%)	7/548 (1.28%)
Polycythaemia † 1	2/554 (0.36%)	0/548 (0.00%)
Idiopathic thrombocytopenic purpura † 1	0/554 (0.00%)	1/548 (0.18%)
Lymphopenia † 1	0/554 (0.00%)	1/548 (0.18%)
Microangiopathic haemolytic anaemia † 1	0/554 (0.00%)	1/548 (0.18%)
Cardiac disorders
Acute myocardial infarction † 1	2/554 (0.36%)	2/548 (0.36%)
Angina pectoris † 1	2/554 (0.36%)	0/548 (0.00%)
Myocardial infarction † 1	2/554 (0.36%)	4/548 (0.73%)
Atrial fibrillation † 1	1/554 (0.18%)	0/548 (0.00%)
Cardiac failure congestive † 1	1/554 (0.18%)	4/548 (0.73%)
Cardiopulmonary failure † 1	1/554 (0.18%)	0/548 (0.00%)
Coronary artery stenosis † 1	1/554 (0.18%)	0/548 (0.00%)
Left ventricular dysfunction † 1	1/554 (0.18%)	1/548 (0.18%)
Palpitations † 1	2/554 (0.36%)	0/548 (0.00%)
Pericardial effusion † 1	1/554 (0.18%)	0/548 (0.00%)
Tachycardia † 1	2/554 (0.36%)	0/548 (0.00%)
Angina unstable † 1	0/554 (0.00%)	1/548 (0.18%)
Atrial thrombosis † 1	0/554 (0.00%)	1/548 (0.18%)
Bradycardia † 1	0/554 (0.00%)	1/548 (0.18%)
Sick sinus syndrome † 1	0/554 (0.00%)	1/548 (0.18%)
Torsade de pointes † 1	0/554 (0.00%)	1/548 (0.18%)
Ear and labyrinth disorders
Sudden hearing loss † 1	0/554 (0.00%)	1/548 (0.18%)
Endocrine disorders
Adrenal insufficiency † 1	0/554 (0.00%)	2/548 (0.36%)
Eye disorders
Retinal detachment † 1	0/554 (0.00%)	1/548 (0.18%)
Gastrointestinal disorders
Vomiting † 1	7/554 (1.26%)	8/548 (1.46%)
Nausea † 1	6/554 (1.08%)	7/548 (1.28%)
Diarrhoea † 1	5/554 (0.90%)	10/548 (1.82%)
Pancreatitis † 1	5/554 (0.90%)	2/548 (0.36%)
Abdominal pain † 1	3/554 (0.54%)	4/548 (0.73%)
Duodenal ulcer † 1	3/554 (0.54%)	0/548 (0.00%)
Ileus † 1	3/554 (0.54%)	0/548 (0.00%)
Gastrointestinal haemorrhage † 1	2/554 (0.36%)	2/548 (0.36%)
Rectal haemorrhage † 1	2/554 (0.36%)	1/548 (0.18%)
Small intestinal haemorrhage † 1	2/554 (0.36%)	0/548 (0.00%)
Abdominal pain upper † 1	1/554 (0.18%)	0/548 (0.00%)
Anal fistula † 1	1/554 (0.18%)	0/548 (0.00%)
Anal ulcer haemorrhage † 1	1/554 (0.18%)	0/548 (0.00%)
Ascites † 1	1/554 (0.18%)	1/548 (0.18%)
Colitis † 1	1/554 (0.18%)	1/548 (0.18%)
Large intestine polyp † 1	1/554 (0.18%)	0/548 (0.00%)
Constipation † 1	2/554 (0.36%)	2/548 (0.36%)
Enterocolitis † 1	1/554 (0.18%)	0/548 (0.00%)
Gastric fistula † 1	1/554 (0.18%)	0/548 (0.00%)
Gastritis † 1	1/554 (0.18%)	2/548 (0.36%)
Gastritis erosive † 1	1/554 (0.18%)	0/548 (0.00%)
Glossodynia † 1	1/554 (0.18%)	0/548 (0.00%)
Inguinal hernia † 1	1/554 (0.18%)	1/548 (0.18%)
Intestinal obstruction † 1	1/554 (0.18%)	2/548 (0.36%)
Lower gastrointestinal haemorrhage † 1	1/554 (0.18%)	0/548 (0.00%)
Lumbar hernia † 1	1/554 (0.18%)	0/548 (0.00%)
Peptic ulcer † 1	1/554 (0.18%)	0/548 (0.00%)
Small intestinal obstruction † 1	1/554 (0.18%)	2/548 (0.36%)
Upper gastrointestinal haemorrhage † 1	2/554 (0.36%)	2/548 (0.36%)
Abdominal distension † 1	0/554 (0.00%)	2/548 (0.36%)
Abdominal pain lower † 1	0/554 (0.00%)	1/548 (0.18%)
Duodenal ulcer haemorrhage † 1	0/554 (0.00%)	2/548 (0.36%)
Erosive oesophagitis † 1	0/554 (0.00%)	1/548 (0.18%)
Gastric haemorrhage † 1	0/554 (0.00%)	1/548 (0.18%)
Haematemesis † 1	0/554 (0.00%)	2/548 (0.36%)
Haematochezia † 1	0/554 (0.00%)	1/548 (0.18%)
Haemorrhoidal haemorrhage † 1	0/554 (0.00%)	1/548 (0.18%)
Obstruction gastric † 1	0/554 (0.00%)	1/548 (0.18%)
Oesophagitis ulcerative † 1	0/554 (0.00%)	1/548 (0.18%)
Pancreatitis acute † 1	1/554 (0.18%)	1/548 (0.18%)
Stomatitis † 1	0/554 (0.00%)	1/548 (0.18%)
Swollen tongue † 1	0/554 (0.00%)	1/548 (0.18%)
Gastrointestinal disorder † 1	1/554 (0.18%)	0/548 (0.00%)
General disorders
Pyrexia † 1	5/554 (0.90%)	14/548 (2.55%)
Fatigue † 1	3/554 (0.54%)	12/548 (2.19%)
Non-cardiac chest pain † 1	3/554 (0.54%)	0/548 (0.00%)
Asthenia † 1	2/554 (0.36%)	4/548 (0.73%)
Chest pain † 1	2/554 (0.36%)	0/548 (0.00%)
Death † 1	1/554 (0.18%)	0/548 (0.00%)
Disease progression † 1	1/554 (0.18%)	1/548 (0.18%)
Impaired healing † 1	1/554 (0.18%)	0/548 (0.00%)
Pain † 1	1/554 (0.18%)	3/548 (0.55%)
General physical health deterioration † 1	0/554 (0.00%)	1/548 (0.18%)
Malaise † 1	0/554 (0.00%)	1/548 (0.18%)
Pneumatosis † 1	0/554 (0.00%)	1/548 (0.18%)
Sudden death † 1	0/554 (0.00%)	1/548 (0.18%)
Hepatobiliary disorders
Hepatotoxicity † 1	8/554 (1.44%)	0/548 (0.00%)
Hepatic function abnormal † 1	7/554 (1.26%)	4/548 (0.73%)
Cholecystitis † 1	2/554 (0.36%)	1/548 (0.18%)
Cholelithiasis † 1	2/554 (0.36%)	1/548 (0.18%)
Cholecystitis acute † 1	1/554 (0.18%)	2/548 (0.36%)
Drug-induced liver injury † 1	1/554 (0.18%)	2/548 (0.36%)
Gallbladder perforation † 1	1/554 (0.18%)	0/548 (0.00%)
Hepatitis † 1	0/554 (0.00%)	1/548 (0.18%)
Hyperbilirubinaemia † 1	0/554 (0.00%)	2/548 (0.36%)
Jaundice cholestatic † 1	0/554 (0.00%)	1/548 (0.18%)
Immune system disorders
Anaphylactic reaction † 1	1/554 (0.18%)	0/548 (0.00%)
Infections and infestations
Pneumonia † 1	4/554 (0.72%)	6/548 (1.09%)
Sepsis † 1	3/554 (0.54%)	1/548 (0.18%)
Urinary tract infection † 1	3/554 (0.54%)	1/548 (0.18%)
Abscess † 1	1/554 (0.18%)	0/548 (0.00%)
Anal abscess † 1	1/554 (0.18%)	0/548 (0.00%)
Appendicitis † 1	1/554 (0.18%)	2/548 (0.36%)
Bronchitis † 1	1/554 (0.18%)	0/548 (0.00%)
Cellulitis † 1	1/554 (0.18%)	1/548 (0.18%)
H1N1 influenza † 1	1/554 (0.18%)	0/548 (0.00%)
Infection † 1	1/554 (0.18%)	0/548 (0.00%)
Lung infection † 1	2/554 (0.36%)	0/548 (0.00%)
Otitis media † 1	1/554 (0.18%)	0/548 (0.00%)
Pneumocystis jiroveci pneumonia † 1	1/554 (0.18%)	0/548 (0.00%)
Pyelonephritis † 1	1/554 (0.18%)	0/548 (0.00%)
Septic shock † 1	1/554 (0.18%)	0/548 (0.00%)
Wound infection † 1	1/554 (0.18%)	0/548 (0.00%)
Bacterial infection † 1	0/554 (0.00%)	1/548 (0.18%)
Febrile infection † 1	0/554 (0.00%)	1/548 (0.18%)
Gastroenteritis † 1	1/554 (0.18%)	2/548 (0.36%)
Herpes zoster † 1	0/554 (0.00%)	1/548 (0.18%)
Lower respiratory tract infection † 1	0/554 (0.00%)	3/548 (0.55%)
Perinephric abscess † 1	0/554 (0.00%)	1/548 (0.18%)
Peritonitis † 1	0/554 (0.00%)	1/548 (0.18%)
Pneumonia bacterial † 1	0/554 (0.00%)	1/548 (0.18%)
Pyelonephritis acute † 1	0/554 (0.00%)	1/548 (0.18%)
Renal abscess † 1	0/554 (0.00%)	1/548 (0.18%)
Retroperitoneal abscess † 1	0/554 (0.00%)	1/548 (0.18%)
Salmonella sepsis † 1	0/554 (0.00%)	1/548 (0.18%)
Injury, poisoning and procedural complications
Acetabulum fracture † 1	2/554 (0.36%)	0/548 (0.00%)
Brain herniation † 1	1/554 (0.18%)	0/548 (0.00%)
Contusion † 1	1/554 (0.18%)	0/548 (0.00%)
Craniocerebral injury † 1	1/554 (0.18%)	0/548 (0.00%)
Femur fracture † 1	1/554 (0.18%)	2/548 (0.36%)
Humerus fracture † 1	1/554 (0.18%)	0/548 (0.00%)
Ilium fracture † 1	1/554 (0.18%)	0/548 (0.00%)
Post procedural discharge † 1	1/554 (0.18%)	0/548 (0.00%)
Tibia fracture † 1	1/554 (0.18%)	0/548 (0.00%)
Ankle fracture † 1	0/554 (0.00%)	1/548 (0.18%)
Chemical poisoning † 1	0/554 (0.00%)	1/548 (0.18%)
Fall † 1	0/554 (0.00%)	2/548 (0.36%)
Fracture † 1	0/554 (0.00%)	1/548 (0.18%)
Patella fracture † 1	0/554 (0.00%)	1/548 (0.18%)
Investigations
Alanine aminotransferase increased † 1	35/554 (6.32%)	8/548 (1.46%)
Aspartate aminotransferase increased † 1	17/554 (3.07%)	2/548 (0.36%)
Lipase increased † 1	7/554 (1.26%)	4/548 (0.73%)
Hepatic enzyme increased † 1	6/554 (1.08%)	1/548 (0.18%)
Gamma-glutamyltransferase increased † 1	3/554 (0.54%)	0/548 (0.00%)
Liver function test abnormal † 1	3/554 (0.54%)	0/548 (0.00%)
Blood bilirubin increased † 1	2/554 (0.36%)	2/548 (0.36%)
Blood creatinine increased † 1	2/554 (0.36%)	0/548 (0.00%)
Neutrophil count decreased † 1	2/554 (0.36%)	0/548 (0.00%)
Blood alkaline phosphatase increased † 1	1/554 (0.18%)	0/548 (0.00%)
Blood glucose decreased † 1	1/554 (0.18%)	0/548 (0.00%)
Blood potassium increased † 1	1/554 (0.18%)	1/548 (0.18%)
Ejection fraction decreased † 1	1/554 (0.18%)	1/548 (0.18%)
Haemoglobin decreased † 1	1/554 (0.18%)	0/548 (0.00%)
Amylase increased † 1	0/554 (0.00%)	1/548 (0.18%)
Blood calcium increased † 1	0/554 (0.00%)	1/548 (0.18%)
Blood creatine phosphokinase increased † 1	0/554 (0.00%)	1/548 (0.18%)
Blood magnesium decreased † 1	0/554 (0.00%)	1/548 (0.18%)
Electrocardiogram QT prolonged † 1	0/554 (0.00%)	1/548 (0.18%)
Platelet count decreased † 1	0/554 (0.00%)	9/548 (1.64%)
Metabolism and nutrition disorders
Dehydration † 1	8/554 (1.44%)	11/548 (2.01%)
Hypercalcaemia † 1	5/554 (0.90%)	1/548 (0.18%)
Hyponatraemia † 1	4/554 (0.72%)	7/548 (1.28%)
Decreased appetite † 1	2/554 (0.36%)	2/548 (0.36%)
Hypocalcaemia † 1	2/554 (0.36%)	0/548 (0.00%)
Electrolyte imbalance † 1	1/554 (0.18%)	0/548 (0.00%)
Hyperkalaemia † 1	1/554 (0.18%)	2/548 (0.36%)
Hyperlipasaemia † 1	1/554 (0.18%)	0/548 (0.00%)
Hyperuricaemia † 1	1/554 (0.18%)	2/548 (0.36%)
Hypokalaemia † 1	1/554 (0.18%)	0/548 (0.00%)
Hyperamylasaemia † 1	0/554 (0.00%)	1/548 (0.18%)
Hypoglycaemia † 1	0/554 (0.00%)	1/548 (0.18%)
Hypophosphataemia † 1	0/554 (0.00%)	1/548 (0.18%)
Malnutrition † 1	0/554 (0.00%)	1/548 (0.18%)
Hyperglycaemia † 1	0/554 (0.00%)	1/548 (0.18%)
Musculoskeletal and connective tissue disorders
Back pain † 1	3/554 (0.54%)	6/548 (1.09%)
Arthralgia † 1	2/554 (0.36%)	0/548 (0.00%)
Flank pain † 1	2/554 (0.36%)	1/548 (0.18%)
Osteolysis † 1	2/554 (0.36%)	0/548 (0.00%)
Bone pain † 1	1/554 (0.18%)	0/548 (0.00%)
Groin pain † 1	1/554 (0.18%)	0/548 (0.00%)
Muscular weakness † 1	2/554 (0.36%)	2/548 (0.36%)
Pain in extremity † 1	1/554 (0.18%)	0/548 (0.00%)
Fistula † 1	0/554 (0.00%)	1/548 (0.18%)
Haemarthrosis † 1	0/554 (0.00%)	1/548 (0.18%)
Intervertebral disc compression † 1	0/554 (0.00%)	1/548 (0.18%)
Musculoskeletal pain † 1	0/554 (0.00%)	1/548 (0.18%)
Pathological fracture † 1	0/554 (0.00%)	1/548 (0.18%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer † 1	1/554 (0.18%)	0/548 (0.00%)
Adenocarcinoma † 1	1/554 (0.18%)	0/548 (0.00%)
Cancer pain † 1	1/554 (0.18%)	0/548 (0.00%)
Endometrial cancer metastatic † 1	1/554 (0.18%)	0/548 (0.00%)
Lipoma † 1	1/554 (0.18%)	0/548 (0.00%)
Metastases to central nervous system † 1	1/554 (0.18%)	2/548 (0.36%)
Metastases to liver † 1	1/554 (0.18%)	0/548 (0.00%)
Metastasis † 1	1/554 (0.18%)	0/548 (0.00%)
Squamous cell carcinoma of skin † 1	1/554 (0.18%)	1/548 (0.18%)
Tumour rupture † 1	1/554 (0.18%)	0/548 (0.00%)
Cholesteatoma † 1	0/554 (0.00%)	1/548 (0.18%)
Gastric cancer † 1	0/554 (0.00%)	1/548 (0.18%)
Malignant melanoma † 1	0/554 (0.00%)	1/548 (0.18%)
Metastases to lung † 1	0/554 (0.00%)	1/548 (0.18%)
Paraneoplastic syndrome † 1	0/554 (0.00%)	1/548 (0.18%)
Parathyroid tumour benign † 1	0/554 (0.00%)	1/548 (0.18%)
Renal cancer metastatic † 1	0/554 (0.00%)	1/548 (0.18%)
Signet-ring cell carcinoma † 1	0/554 (0.00%)	1/548 (0.18%)
Tumour associated fever † 1	0/554 (0.00%)	1/548 (0.18%)
Tumour haemorrhage † 1	0/554 (0.00%)	1/548 (0.18%)
Adenocarcinoma of colon † 1	1/554 (0.18%)	1/548 (0.18%)
Basal cell carcinoma † 1	0/554 (0.00%)	1/548 (0.18%)
Nervous system disorders
Cerebral haemorrhage † 1	4/554 (0.72%)	1/548 (0.18%)
Spinal cord compression † 1	4/554 (0.72%)	3/548 (0.55%)
Transient ischaemic attack † 1	3/554 (0.54%)	1/548 (0.18%)
Cerebrovascular accident † 1	2/554 (0.36%)	0/548 (0.00%)
Headache † 1	2/554 (0.36%)	1/548 (0.18%)
Anaesthesia † 1	1/554 (0.18%)	0/548 (0.00%)
Central nervous system haemorrhage † 1	1/554 (0.18%)	1/548 (0.18%)
Convulsion † 1	2/554 (0.36%)	3/548 (0.55%)
Dizziness † 1	2/554 (0.36%)	1/548 (0.18%)
Encephalopathy † 1	1/554 (0.18%)	0/548 (0.00%)
Haemorrhage intracranial † 1	1/554 (0.18%)	0/548 (0.00%)
Ischaemic stroke † 1	1/554 (0.18%)	0/548 (0.00%)
Metabolic encephalopathy † 1	1/554 (0.18%)	0/548 (0.00%)
Paraplegia † 1	1/554 (0.18%)	0/548 (0.00%)
Syncope † 1	1/554 (0.18%)	4/548 (0.73%)
Cerebral infarction † 1	0/554 (0.00%)	1/548 (0.18%)
Cerebral ischaemia † 1	0/554 (0.00%)	2/548 (0.36%)
Haemorrhagic cerebral infarction † 1	0/554 (0.00%)	1/548 (0.18%)
Hypoaesthesia † 1	0/554 (0.00%)	2/548 (0.36%)
Lethargy † 1	0/554 (0.00%)	1/548 (0.18%)
Loss of consciousness † 1	0/554 (0.00%)	1/548 (0.18%)
Motor dysfunction † 1	0/554 (0.00%)	1/548 (0.18%)
Paraesthesia † 1	0/554 (0.00%)	1/548 (0.18%)
Presyncope † 1	0/554 (0.00%)	1/548 (0.18%)
Subarachnoid haemorrhage † 1	0/554 (0.00%)	1/548 (0.18%)
Tremor † 1	0/554 (0.00%)	1/548 (0.18%)
Psychiatric disorders
Confusional state † 1	1/554 (0.18%)	2/548 (0.36%)
Mental status changes † 1	1/554 (0.18%)	0/548 (0.00%)
Anxiety † 1	0/554 (0.00%)	1/548 (0.18%)
Emotional distress † 1	0/554 (0.00%)	1/548 (0.18%)
Sleep disorder † 1	0/554 (0.00%)	1/548 (0.18%)
Renal and urinary disorders
Renal failure acute † 1	4/554 (0.72%)	9/548 (1.64%)
Haematuria † 1	2/554 (0.36%)	2/548 (0.36%)
Proteinuria † 1	1/554 (0.18%)	1/548 (0.18%)
Renal failure † 1	1/554 (0.18%)	4/548 (0.73%)
Renal haemorrhage † 1	1/554 (0.18%)	0/548 (0.00%)
Ureteric obstruction † 1	1/554 (0.18%)	0/548 (0.00%)
Urinary retention † 1	1/554 (0.18%)	0/548 (0.00%)
Nephrotic syndrome † 1	0/554 (0.00%)	1/548 (0.18%)
Renal impairment † 1	0/554 (0.00%)	1/548 (0.18%)
Reproductive system and breast disorders
Bartholin's cyst † 1	1/554 (0.18%)	0/548 (0.00%)
Penile oedema † 1	1/554 (0.18%)	0/548 (0.00%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism † 1	8/554 (1.44%)	8/548 (1.46%)
Dyspnoea † 1	6/554 (1.08%)	8/548 (1.46%)
Haemoptysis † 1	3/554 (0.54%)	2/548 (0.36%)
Respiratory failure † 1	2/554 (0.36%)	2/548 (0.36%)
Hydropneumothorax † 1	1/554 (0.18%)	0/548 (0.00%)
Hypoxia † 1	1/554 (0.18%)	0/548 (0.00%)
Pleural effusion † 1	1/554 (0.18%)	11/548 (2.01%)
Pleurisy † 1	1/554 (0.18%)	0/548 (0.00%)
Pleuritic pain † 1	1/554 (0.18%)	0/548 (0.00%)
Pneumonitis † 1	1/554 (0.18%)	2/548 (0.36%)
Pneumothorax † 1	1/554 (0.18%)	2/548 (0.36%)
Acute respiratory failure † 1	0/554 (0.00%)	1/548 (0.18%)
Chronic obstructive pulmonary disease † 1	0/554 (0.00%)	2/548 (0.36%)
Cough † 1	0/554 (0.00%)	1/548 (0.18%)
Epistaxis † 1	0/554 (0.00%)	6/548 (1.09%)
Hiccups † 1	0/554 (0.00%)	1/548 (0.18%)
Laryngeal haemorrhage † 1	0/554 (0.00%)	1/548 (0.18%)
Lung infiltration † 1	0/554 (0.00%)	1/548 (0.18%)
Pneumonia aspiration † 1	0/554 (0.00%)	2/548 (0.36%)
Pulmonary artery thrombosis † 1	0/554 (0.00%)	1/548 (0.18%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome † 1	2/554 (0.36%)	0/548 (0.00%)
Angioedema † 1	1/554 (0.18%)	0/548 (0.00%)
Decubitus ulcer † 1	1/554 (0.18%)	0/548 (0.00%)
Dry gangrene † 1	1/554 (0.18%)	0/548 (0.00%)
Rash † 1	1/554 (0.18%)	0/548 (0.00%)
Actinic keratosis † 1	0/554 (0.00%)	1/548 (0.18%)
Vascular disorders
Hypertension † 1	6/554 (1.08%)	7/548 (1.28%)
Deep vein thrombosis † 1	2/554 (0.36%)	0/548 (0.00%)
Hypertensive crisis † 1	2/554 (0.36%)	0/548 (0.00%)
Aortic thrombosis † 1	1/554 (0.18%)	0/548 (0.00%)
Hypotension † 1	1/554 (0.18%)	1/548 (0.18%)
Thrombosis † 1	1/554 (0.18%)	1/548 (0.18%)
Vena cava thrombosis † 1	1/554 (0.18%)	1/548 (0.18%)
Angiodysplasia † 1	0/554 (0.00%)	1/548 (0.18%)
Arterial rupture † 1	0/554 (0.00%)	1/548 (0.18%)
Haematoma † 1	0/554 (0.00%)	1/548 (0.18%)
Orthostatic hypotension † 1	0/554 (0.00%)	1/548 (0.18%)
Temporal ateritis † 1	0/554 (0.00%)	1/548 (0.18%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pazopanib 800 mg	Sunitinib 50 mg
	Affected / at Risk (%)	Affected / at Risk (%)
Total	541/554 (97.65%)	535/548 (97.63%)
Blood and lymphatic system disorders
Neutropenia † 1	60/554 (10.83%)	146/548 (26.64%)
Thrombocytopenia † 1	56/554 (10.11%)	180/548 (32.85%)
Leukopenia † 1	51/554 (9.21%)	99/548 (18.07%)
Anaemia † 1	36/554 (6.50%)	99/548 (18.07%)
Endocrine disorders
Hypothyroidism † 1	71/554 (12.82%)	136/548 (24.82%)
Hyperthyroidism † 1	7/554 (1.26%)	29/548 (5.29%)
Eye disorders
Eyelid oedema † 1	19/554 (3.43%)	42/548 (7.66%)
Gastrointestinal disorders
Diarrhoea † 1	349/554 (63.00%)	312/548 (56.93%)
Nausea † 1	246/554 (44.40%)	249/548 (45.44%)
Vomiting † 1	157/554 (28.34%)	148/548 (27.01%)
Constipation † 1	97/554 (17.51%)	133/548 (24.27%)
Dyspepsia † 1	80/554 (14.44%)	134/548 (24.45%)
Stomatitis † 1	78/554 (14.08%)	153/548 (27.92%)
Abdominal pain † 1	70/554 (12.64%)	72/548 (13.14%)
Abdominal pain upper † 1	70/554 (12.64%)	48/548 (8.76%)
Abdominal distension † 1	33/554 (5.96%)	24/548 (4.38%)
Flatulence † 1	32/554 (5.78%)	15/548 (2.74%)
Dry mouth † 1	26/554 (4.69%)	29/548 (5.29%)
Abdominal discomfort † 1	24/554 (4.33%)	34/548 (6.20%)
Mouth ulceration † 1	23/554 (4.15%)	37/548 (6.75%)
Gastrooesophageal reflux disease † 1	20/554 (3.61%)	57/548 (10.40%)
General disorders
Fatigue † 1	305/554 (55.05%)	343/548 (62.59%)
Mucosal inflammation † 1	61/554 (11.01%)	141/548 (25.73%)
Oedema peripheral † 1	56/554 (10.11%)	85/548 (15.51%)
Asthenia † 1	48/554 (8.66%)	58/548 (10.58%)
Pyrexia † 1	47/554 (8.48%)	77/548 (14.05%)
Chills † 1	15/554 (2.71%)	43/548 (7.85%)
Oedema † 1	16/554 (2.89%)	36/548 (6.57%)
Face oedema † 1	12/554 (2.17%)	40/548 (7.30%)
Infections and infestations
Nasopharyngitis † 1	46/554 (8.30%)	46/548 (8.39%)
Upper respiratory tract infection † 1	30/554 (5.42%)	34/548 (6.20%)
Urinary tract infection † 1	22/554 (3.97%)	29/548 (5.29%)
Investigations
Alanine aminotransferase increased † 1	143/554 (25.81%)	93/548 (16.97%)
Aspartate aminotransferase increased † 1	131/554 (23.65%)	98/548 (17.88%)
Weight decreased † 1	85/554 (15.34%)	33/548 (6.02%)
Blood creatinine increased † 1	59/554 (10.65%)	93/548 (16.97%)
Blood bilirubin increased † 1	51/554 (9.21%)	35/548 (6.39%)
Blood alkaline phosphatase increased † 1	40/554 (7.22%)	30/548 (5.47%)
Lipase increased † 1	42/554 (7.58%)	32/548 (5.84%)
Blood lactate dehydrogenase increased † 1	40/554 (7.22%)	60/548 (10.95%)
Platelet count decreased † 1	36/554 (6.50%)	97/548 (17.70%)
Amylase increased † 1	37/554 (6.68%)	24/548 (4.38%)
Haemoglobin decreased † 1	34/554 (6.14%)	5/548 (0.91%)
Blood thyroid stimulating hormone increased † 1	32/554 (5.78%)	66/548 (12.04%)
White blood cell count decreased † 1	31/554 (5.60%)	74/548 (13.50%)
Neutrophil count decreased † 1	27/554 (4.87%)	62/548 (11.31%)
Blood triglycerides increased † 1	21/554 (3.79%)	35/548 (6.39%)
Metabolism and nutrition disorders
Decreased appetite † 1	207/554 (37.36%)	203/548 (37.04%)
Hypophosphataemia † 1	21/554 (3.79%)	32/548 (5.84%)
Hyponatraemia † 1	22/554 (3.97%)	36/548 (6.57%)
Hyperglycaemia † 1	16/554 (2.89%)	30/548 (5.47%)
Musculoskeletal and connective tissue disorders
Back pain † 1	90/554 (16.25%)	89/548 (16.24%)
Arthralgia † 1	77/554 (13.90%)	67/548 (12.23%)
Pain in extremity † 1	68/554 (12.27%)	93/548 (16.97%)
Musculoskeletal pain † 1	43/554 (7.76%)	28/548 (5.11%)
Muscle spasms † 1	37/554 (6.68%)	22/548 (4.01%)
Myalgia † 1	35/554 (6.32%)	41/548 (7.48%)
Flank pain † 1	14/554 (2.53%)	30/548 (5.47%)
Nervous system disorders
Dysgeusia † 1	144/554 (25.99%)	198/548 (36.13%)
Headache † 1	124/554 (22.38%)	122/548 (22.26%)
Dizziness † 1	70/554 (12.64%)	82/548 (14.96%)
Psychiatric disorders
Insomnia † 1	59/554 (10.65%)	61/548 (11.13%)
Renal and urinary disorders
Proteinuria † 1	99/554 (17.87%)	76/548 (13.87%)
Hematuria † 1	24/554 (4.33%)	28/548 (5.11%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	86/554 (15.52%)	104/548 (18.98%)
Dyspnoea † 1	77/554 (13.90%)	92/548 (16.79%)
Epistaxis † 1	49/554 (8.84%)	96/548 (17.52%)
Dysphonia † 1	42/554 (7.58%)	12/548 (2.19%)
Oropharyngeal pain † 1	39/554 (7.04%)	54/548 (9.85%)
Skin and subcutaneous tissue disorders
Hair colour changes † 1	168/554 (30.32%)	53/548 (9.67%)
Palmar-plantar erythrodysaesthesia syndrome † 1	163/554 (29.42%)	275/548 (50.18%)
Rash † 1	96/554 (17.33%)	126/548 (22.99%)
Alopecia † 1	77/554 (13.90%)	45/548 (8.21%)
Dry skin † 1	44/554 (7.94%)	47/548 (8.58%)
Skin hypopigmentation † 1	27/554 (4.87%)	7/548 (1.28%)
Pruritus † 1	22/554 (3.97%)	44/548 (8.03%)
Yellow skin † 1	4/554 (0.72%)	83/548 (15.15%)
Vascular disorders
Hypertension † 1	256/554 (46.21%)	222/548 (40.51%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact

• Name/Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals
• Phone: 862-778-8300

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sheng X, Jin J, He Z, Huang Y, Zhou A, Wang J, Ren X, Ye D, Zhang X, Qin S, Zhou F, Wang B, Guo J. Pazopanib versus sunitinib in Chinese patients with locally advanced or metastatic renal cell carcinoma: pooled subgroup analysis from the randomized, COMPARZ studies. BMC Cancer. 2020 Mar 14;20(1):219. doi: 10.1186/s12885-020-6708-8.

Sternberg CN, Motzer RJ, Hutson TE, Choueiri TK, Kollmannsberger C, Bjarnason GA, Paul Nathan, Porta C, Grunwald V, Dezzani L, Han J, Tannir NM. COMPARZ Post Hoc Analysis: Characterizing Pazopanib Responders With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2019 Dec;17(6):425-435.e4. doi: 10.1016/j.clgc.2019.01.015. Epub 2019 Feb 6.

Guo J, Jin J, Oya M, Uemura H, Takahashi S, Tatsugami K, Rha SY, Lee JL, Chung J, Lim HY, Wu HC, Chang YH, Azad A, Davis ID, Carrasco-Alfonso MJ, Nanua B, Han J, Ahmad Q, Motzer R. Safety of pazopanib and sunitinib in treatment-naive patients with metastatic renal cell carcinoma: Asian versus non-Asian subgroup analysis of the COMPARZ trial. J Hematol Oncol. 2018 May 22;11(1):69. doi: 10.1186/s13045-018-0617-1.

Grunwald V, Dietrich M, Pond GR. Early tumor shrinkage is independently associated with improved overall survival among patients with metastatic renal cell carcinoma: a validation study using the COMPARZ cohort. World J Urol. 2018 Sep;36(9):1423-1429. doi: 10.1007/s00345-018-2297-4. Epub 2018 Apr 13.

Beaumont JL, Salsman JM, Diaz J, Deen KC, McCann L, Powles T, Hackshaw MD, Motzer RJ, Cella D. Quality-adjusted time without symptoms or toxicity analysis of pazopanib versus sunitinib in patients with renal cell carcinoma. Cancer. 2016 Apr 1;122(7):1108-15. doi: 10.1002/cncr.29888. Epub 2016 Jan 27.

Goldstein D, Rosenberg JE, Figlin RA, Townsend RR, McCann L, Carpenter C, Pandite L. Is change in blood pressure a biomarker of pazopanib and sunitinib efficacy in advanced/metastatic renal cell carcinoma? Eur J Cancer. 2016 Jan;53:96-104. doi: 10.1016/j.ejca.2015.10.006. Epub 2015 Dec 15.

Sorich MJ, Kichenadasse G, Rowland A, Woodman RJ, Mangoni AA. Angiotensin system inhibitors and survival in patients with metastatic renal cell carcinoma treated with VEGF-targeted therapy: A pooled secondary analysis of clinical trials. Int J Cancer. 2016 May 1;138(9):2293-9. doi: 10.1002/ijc.29972. Epub 2016 Jan 6.

Lai JS, Beaumont JL, Diaz J, Khan S, Cella D. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma. Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.

Motzer RJ, Hutson TE, Cella D, Reeves J, Hawkins R, Guo J, Nathan P, Staehler M, de Souza P, Merchan JR, Boleti E, Fife K, Jin J, Jones R, Uemura H, De Giorgi U, Harmenberg U, Wang J, Sternberg CN, Deen K, McCann L, Hackshaw MD, Crescenzo R, Pandite LN, Choueiri TK. Pazopanib versus sunitinib in metastatic renal-cell carcinoma. N Engl J Med. 2013 Aug 22;369(8):722-31. doi: 10.1056/NEJMoa1303989.

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• ClinicalTrials.gov Identifier: NCT00720941
• Other Study ID Numbers: 108844; 2008-002102-19 ( EudraCT Number ); CPZP034A2301 ( Other Identifier: Novartis )
• First Submitted: July 22, 2008
• First Posted: July 23, 2008
• Results First Submitted: January 4, 2013
• Results First Posted: June 17, 2013
• Last Update Posted: May 13, 2021