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

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ClinicalTrials.gov Identifier: NCT00720941
Recruitment Status : Active, not recruiting
First Posted : July 23, 2008
Results First Posted : June 17, 2013
Last Update Posted : December 3, 2020
Sponsor:
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
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
Hide 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
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg Total
Hide 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
Hide 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
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
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Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
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Hide 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
Hide 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
Hide 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
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Hide 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
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/--   --/-- 
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: December 3, 2020