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Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00866697
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : December 19, 2013
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Drug: Pazopanib
Drug: Placebo
Enrollment 940
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description Participants received matching placebo once daily for a maximum of 24 months. Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Period Title: Overall Study
Started 468 472
Completed [1] 254 244
Not Completed 214 228
Reason Not Completed
Study closed/terminated             156             138
Lost to Follow-up             22             28
Physician Decision             3             5
Withdrawal by Subject             33             57
[1]
Death
Arm/Group Title Placebo Pazopanib 800 mg Total
Hide Arm/Group Description Participants received matching placebo once daily for a maximum of 24 months. Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months. Total of all reporting groups
Overall Number of Baseline Participants 468 472 940
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 468 participants 472 participants 940 participants
56.8  (10.83) 55.8  (10.54) 56.3  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 468 participants 472 participants 940 participants
Female
468
 100.0%
472
 100.0%
940
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 468 participants 472 participants 940 participants
African American/African Heritage
1
   0.2%
2
   0.4%
3
   0.3%
American Indian or Alaska Native
1
   0.2%
1
   0.2%
2
   0.2%
Central/South Asian Heritage (Her)
1
   0.2%
0
   0.0%
1
   0.1%
Japanese/East Asian Her/South East Asian Her
102
  21.8%
106
  22.5%
208
  22.1%
White
363
  77.6%
363
  76.9%
726
  77.2%
1.Primary Outcome
Title Investigator-assessed Progression-free Survival (PFS)
Hide Description PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.
Time Frame From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 468 472
Median (95% Confidence Interval)
Unit of Measure: months
12.3
(11.8 to 17.7)
17.9
(15.9 to 21.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pazopanib 800 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments The P-value from the stratified log-rank test was adjusted for the two stratification factors.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.766
Confidence Interval (2-Sided) 95%
0.643 to 0.911
Estimation Comments The Hazard Ratio was estimated using a Pike estimator.
2.Secondary Outcome
Title Overall Survival - Median
Hide Description Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
Time Frame From the date of randomization until the date of death due to any cause up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 468 472
Median (95% Confidence Interval)
Unit of Measure: months
64.0
(56.0 to 75.7)
59.1
(53.5 to 71.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pazopanib 800 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6431
Comments [Not Specified]
Method Log Rank
Comments Stratified Log-Rank P-Value.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.960
Confidence Interval (2-Sided) 95%
0.805 to 1.145
Estimation Comments

The HR was estimated using a Pike estimator.

CIs were estimated using the Brookmeyer-Crowley method.

3.Secondary Outcome
Title Overall Survival: Number of Participants Experiencing Death
Hide Description Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
Time Frame From the date of randomization until the date of death due to any cause up to approximately 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 468 472
Measure Type: Number
Unit of Measure: participants
deaths 253 241
censored, follow up ended (no deaths) 215 231
4.Secondary Outcome
Title Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria
Hide Description Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.
Time Frame From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
Hide Outcome Measure Data
Hide Analysis Population Description

Intent-to-Treat (ITT) Population: all randomized participants.

For participants who did not progress or die, progression-free survival was censored at the time of the last adequate disease assessment.

Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 468 472
Median (95% Confidence Interval)
Unit of Measure: months
11.9
(10.6 to 14.9)
16.8
(12.6 to 18.1)
5.Secondary Outcome
Title 3-year Progression-free Survival
Hide Description 3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame Up to 3 years after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomized participants.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 468 472
Measure Type: Number
Unit of Measure: percentage of participants
NA [1]  NA [1] 
[1]
At the time of data cut-off, only one participant had more than 3 years of follow-up; therefore, 3-year progression-free survival could not be estimated.
6.Secondary Outcome
Title Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 ("poor" to "excellent"). Participants were asked to respond to the following questions using the 7-item Likert scale: "How would you rate your overall health during the past week"; "How would you rate your overall quality of life during the past week?" Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA).
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 393 293
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 393 participants 293 participants
0.58  (0.821) -3.82  (0.950)
Month 7 Number Analyzed 316 participants 223 participants
0.95  (0.962) -4.65  (1.139)
Month 10 Number Analyzed 240 participants 184 participants
1.98  (0.972) -4.28  (1.115)
Month 13 Number Analyzed 190 participants 140 participants
0.65  (1.200) -1.80  (1.398)
Month 16 Number Analyzed 137 participants 87 participants
1.39  (1.370) 0.96  (1.702)
Month 25 Number Analyzed 92 participants 53 participants
3.86  (1.488) -1.68  (1.934)
7.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 378 291
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 378 participants 291 participants
9.92  (1.110) 4.24  (1.263)
Month 7 Number Analyzed 299 participants 223 participants
12.10  (1.203) 4.94  (1.385)
Month 10 Number Analyzed 228 participants 185 participants
14.31  (1.310) 8.54  (1.467)
Month 13 Number Analyzed 182 participants 138 participants
15.45  (1.388) 10.07  (1.589)
Month 16 Number Analyzed 133 participants 88 participants
15.81  (1.668) 13.25  (2.013)
Month 25 Number Analyzed 90 participants 54 participants
16.50  (2.021) 5.72  (2.565)
8.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 386 297
Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 386 participants 297 participants
7.18  (1.063) 2.99  (1.210)
Month 7 Number Analyzed 312 participants 230 participants
7.88  (1.141) 4.26  (1.319)
Month 10 Number Analyzed 236 participants 190 participants
8.12  (1.319) 4.65  (1.482)
Month 13 Number Analyzed 187 participants 145 participants
8.54  (1.421) 4.34  (1.616)
Month 16 Number Analyzed 133 participants 91 participants
7.68  (1.633) 6.21  (1.941)
Month 25 Number Analyzed 88 participants 56 participants
10.81  (1.856) 3.10  (2.281)
9.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 388 297
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 388 participants 297 participants
-3.34  (1.038) -5.22  (1.184)
Month 7 Number Analyzed 301 participants 226 participants
-6.12  (1.104) -5.20  (1.270)
Month 10 Number Analyzed 235 participants 188 participants
-7.85  (1.209) -5.11  (1.361)
Month 13 Number Analyzed 188 participants 140 participants
-8.76  (1.301) -6.37  (1.499)
Month 16 Number Analyzed 133 participants 90 participants
-8.66  (1.456) -8.65  (1.745)
Month 25 Number Analyzed 91 participants 55 participants
-9.47  (1.595) -8.30  (2.010)
10.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 388 289
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 388 participants 289 participants
0.93  (0.673) 6.62  (0.777)
Month 7 Number Analyzed 308 participants 225 participants
2.36  (0.831) 11.11  (0.967)
Month 10 Number Analyzed 232 participants 187 participants
2.74  (0.957) 11.33  (0.957)
Month 13 Number Analyzed 187 participants 141 participants
3.64  (1.027) 12.29  (1.181)
Month 16 Number Analyzed 133 participants 88 participants
3.69  (1.251) 8.11  (1.503)
Month 25 Number Analyzed 91 participants 54 participants
3.82  (1.388) 11.86  (1.762)
11.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 398 299
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 398 participants 299 participants
-0.86  (1.026) -0.95  (1.177)
Month 7 Number Analyzed 315 participants 232 participants
-0.38  (1.185) 1.29  (1.371)
Month 10 Number Analyzed 239 participants 189 participants
-2.17  (1.299) 0.83  (1.470)
Month 13 Number Analyzed 186 participants 144 participants
-2.77  (1.396) -0.74  (1.594)
Month 16 Number Analyzed 136 participants 91 participants
-0.41  (1.610) 1.09  (1.920)
Month 25 Number Analyzed 92 participants 55 participants
-1.58  (1.798) -0.68  (2.280)
12.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed due to low compliance (<50% at Baseline).
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
Hide Outcome Measure Data
Hide Analysis Population Description

Intent-to-Treat (ITT) Population: all randomized participants.

Only those participants available at the specified time points were analyzed.

Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 371 288
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 371 participants 288 participants
1.35  (0.876) 1.20  (0.993)
Month 7 Number Analyzed 301 participants 220 participants
3.00  (0.929) 1.69  (1.076)
Month 10 Number Analyzed 225 participants 179 participants
3.68  (1.048) 0.98  (1.179)
Month 13 Number Analyzed 179 participants 136 participants
2.92  (1.194) 2.49  (1.369)
Month 16 Number Analyzed 127 participants 87 participants
3.30  (1.219) 3.51  (1.451)
Month 25 Number Analyzed 86 participants 53 participants
6.87  (1.534) 1.71  (1.937)
15.Secondary Outcome
Title Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25
Hide Description The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Time Frame Baseline; Week 13; Months 7, 10, 13, 16, and 25
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Hide Analysis Population Description

Intent-to-Treat (ITT) Population: all randomized participants.

Only those participants available at the specified time points were analyzed.

Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 376 293
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 13 Number Analyzed 376 participants 293 participants
0.00  (0.009) -0.04  (0.010)
Month 7 Number Analyzed 303 participants 226 participants
0.00  (0.010) -0.04  (0.012)
Month 10 Number Analyzed 228 participants 181 participants
0.01  (0.011) -0.04  (0.012)
Month 13 Number Analyzed 185 participants 138 participants
0.01  (0.011) -0.01  (0.013)
Month 16 Number Analyzed 129 participants 87 participants
-0.00  (0.014) 0.03  (0.017)
Month 25 Number Analyzed 88 participants 56 participants
0.00  (0.016) -0.02  (0.020)
16.Secondary Outcome
Title Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.
Time Frame From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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All Treated Population
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 461 477
Measure Type: Number
Unit of Measure: participants
Hypertension, G2 52 95
Hypertension, G3 25 139
Hypertension, G4 0 0
Diarrhoea, G2 22 97
Diarrhoea, G3 5 38
Diarrhoea, G4 0 1
Nausea, G2 15 42
Nausea, G3 0 4
Nausea, G4 0 0
Headache, G2 6 36
Headache, G3 3 8
Headache, G4 0 0
Fatigue, G2 19 42
Fatigue, G3 1 7
Fatigue, G4 0 0
Neutropenia, G2 17 51
Neutropenia, G3 2 29
Neutropenia, G4 2 3
Dysgeusia, G2 0 16
Dysgeusia, G3 0 0
Dysgeusia, G4 0 0
Abdominal pain, G2 21 26
Abdominal pain, G3 5 5
Abdominal pain, G4 0 0
Alanine aminotransferase increased, G2 4 22
Alanine aminotransferase increased, G3 0 24
Alanine aminotransferase increased, G4 1 4
Hair color changes, G2 0 13
Hair color changes, G3 0 0
Hair color changes, G4 0 0
Decreased appetite, G2 2 19
Decreased appetite, G3 0 1
Decreased appetite, G4 0 0
Vomiting, G2 8 21
Vomiting, G3 1 4
Vomiting, G4 0 0
Aspartate aminotransferase increased, G2 3 22
Aspartate aminotransferase increased, G3 0 10
Aspartate aminotransferase increased, G4 1 3
Arthralgia, G2 13 19
Arthralgia, G3 3 5
Arthralgia, G4 0 0
Abdominal pain upper, G2 3 20
Abdominal pain upper, G3 1 1
Abdominal pain upper, G4 0 1
Asthenia, G2 8 28
Asthenia, G3 0 6
Asthenia, G4 0 0
Palmar-plantar erythrodysaesthesia syndrome, G2 2 42
Palmar-plantar erythrodysaesthesia syndrome, G3 1 9
Palmar-plantar erythrodysaesthesia syndrome, G4 0 0
Thrombocytopenia, G2 1 15
Thrombocytopenia, G3 1 6
Thrombocytopenia, G4 2 3
Hypothyroidism, G2 9 19
Hypothyroidism, G3 0 0
Hypothyroidism, G4 0 0
Constipation, G2 20 12
Constipation, G3 1 1
Constipation, G4 0 0
17.Secondary Outcome
Title Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade
Hide Description Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.
Time Frame From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Hide Analysis Population Description
All Treated Population. Only those participants contributing toxicity data were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 456 466
Measure Type: Number
Unit of Measure: participants
Hemoglobin, Any grade increase Number Analyzed 456 participants 466 participants
44 68
Hemoglobin, Increase to Grade 3 Number Analyzed 456 participants 466 participants
0 0
Hemoglobin, Increase to Grade 4 Number Analyzed 456 participants 466 participants
0 0
Lymphocytes, Any grade increase Number Analyzed 453 participants 461 participants
75 91
Lymphocytes, Increase to Grade 3 Number Analyzed 453 participants 461 participants
1 13
Lymphocytes, Increase to Grade 4 Number Analyzed 453 participants 461 participants
0 0
Neutrophils, Any grade increase Number Analyzed 455 participants 462 participants
80 236
Neutrophils, Increase to Grade 3 Number Analyzed 455 participants 462 participants
2 44
Neutrophils, Increase to Grade 4 Number Analyzed 455 participants 462 participants
0 5
Platelets, Any grade increase Number Analyzed 456 participants 465 participants
25 167
Platelets, Increase to Grade 3 Number Analyzed 456 participants 465 participants
1 8
Platelets, Increase to Grade 4 Number Analyzed 456 participants 465 participants
1 4
WBC count, Any grade increase Number Analyzed 456 participants 465 participants
77 236
WBC count, Increase to Grade 3 Number Analyzed 456 participants 465 participants
0 11
WBC count, Increase to Grade 4 Number Analyzed 456 participants 465 participants
0 1
18.Secondary Outcome
Title Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade
Hide Description Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.
Time Frame From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Hide Analysis Population Description
All Treated Population. Only those participants contributing toxicity data were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 456 465
Measure Type: Number
Unit of Measure: participants
Albumin, Any grade increase Number Analyzed 450 participants 455 participants
33 50
Albumin, Increase to Grade 3 Number Analyzed 450 participants 455 participants
0 0
Albumin, Increase to Grade 4 Number Analyzed 450 participants 455 participants
0 0
Creatinine, Any grade increase Number Analyzed 456 participants 465 participants
27 42
Creatinine, Increase to Grade 3 Number Analyzed 456 participants 465 participants
0 1
Creatinine, Increase to Grade 4 Number Analyzed 456 participants 465 participants
0 0
Hypercalcemia, Any grade increase Number Analyzed 456 participants 462 participants
33 16
Hypercalcemia, Increase to Grade 3 Number Analyzed 456 participants 462 participants
0 0
Hypercalcemia, Increase to Grade 4 Number Analyzed 456 participants 462 participants
0 0
Hyperglycemia, Any grade increase Number Analyzed 446 participants 453 participants
117 128
Hyperglycemia, Increase to Grade 3 Number Analyzed 446 participants 453 participants
10 2
Hyperglycemia, Increase to Grade 4 Number Analyzed 446 participants 453 participants
0 0
Hyperkalemia, Any grade increase Number Analyzed 455 participants 464 participants
39 38
Hyperkalemia, Increase to Grade 3 Number Analyzed 455 participants 464 participants
2 1
Hyperkalemia, Increase to Grade 4 Number Analyzed 455 participants 464 participants
0 2
Hypermagnesemia, Any grade increase Number Analyzed 439 participants 447 participants
11 20
Hypermagnesemia, Increase to Grade 3 Number Analyzed 439 participants 447 participants
1 6
Hypermagnesemia, Increase to Grade 4 Number Analyzed 439 participants 447 participants
1 0
Hypernatremia, Any grade increase Number Analyzed 455 participants 463 participants
26 25
Hypernatremia, Increase to Grade 3 Number Analyzed 455 participants 463 participants
0 0
Hypernatremia, Increase to Grade 4 Number Analyzed 455 participants 463 participants
0 0
Hypocalcemia, Any grade increase Number Analyzed 456 participants 462 participants
21 52
Hypocalcemia, Increase to Grade 3 Number Analyzed 456 participants 462 participants
0 2
Hypocalcemia, Increase to Grade 4 Number Analyzed 456 participants 462 participants
0 0
Hypoglycemia, Any grade increase Number Analyzed 446 participants 453 participants
25 41
Hypoglycemia, Increase to Grade 3 Number Analyzed 446 participants 453 participants
2 0
Hypoglycemia, Increase to Grade 4 Number Analyzed 446 participants 453 participants
2 2
Hypokalemia, Any grade increase Number Analyzed 455 participants 464 participants
31 40
Hypokalemia, Increase to Grade 3 Number Analyzed 455 participants 464 participants
1 2
Hypokalemia, Increase to Grade 4 Number Analyzed 455 participants 464 participants
1 0
Hypomagnesemia, Any grade increase Number Analyzed 439 participants 447 participants
55 65
Hypomagnesemia, Increase to Grade 3 Number Analyzed 439 participants 447 participants
3 1
Hypomagnesemia, Increase to Grade 4 Number Analyzed 439 participants 447 participants
0 2
Hyponatremia, Any grade increase Number Analyzed 455 participants 463 participants
37 45
Hyponatremia, Increase to Grade 3 Number Analyzed 455 participants 463 participants
5 9
Hyponatremia, Increase to Grade 4 Number Analyzed 455 participants 463 participants
0 0
Phosphate, Any grade increase Number Analyzed 409 participants 401 participants
33 24
Phosphate, Increase to Grade 3 Number Analyzed 409 participants 401 participants
4 0
Phosphate, Increase to Grade 4 Number Analyzed 409 participants 401 participants
0 1
19.Secondary Outcome
Title Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L)
Hide Description Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).
Time Frame From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
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Hide Analysis Population Description
All Treated Population. Only those participants with any TSH above 5 MU/L were analyzed.
Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 42 157
Measure Type: Number
Unit of Measure: participants
5 <TSH <=10 MU/L 34 94
10 <TSH <=20 MU/L 4 36
TSH >20 MU/L 4 27
20.Post-Hoc Outcome
Title All Collected Deaths
Hide Description On-treatment deaths were collected from first dose of study treatment up to 28 days after study drug discontinuation, for a maximum duration of 27 months. Deaths post treatment survival follow up were collected after the on treatment period, up to 96 months (8 years).
Time Frame on-treatment: up to 27 months; post-treatment: up to 96 months (8 years).
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Hide Analysis Population Description

Treated set.

One randomized patient in each treatment arm was excluded from the All Treated population because they did not receive treatment. The pazopanib group included 6 patients who were randomized to placebo but took at least one dose of pazopanib.

Four patients (one in placebo, three in pazopanib) had missing death dates and therefore were treated as censored at the last contact date.

Arm/Group Title Placebo Pazopanib 800 mg
Hide Arm/Group Description:
Participants received matching placebo once daily for a maximum of 24 months.
Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
Overall Number of Participants Analyzed 461 477
Measure Type: Number
Unit of Measure: participants
All Treated Population 461 477
Total deaths 252 245
On-treatment Deaths - occurring less than or equal to 28 days from last dose 0 3
Time Frame Adverse events were reported from first dose of study treatment until end of study treatment plus 28 days post treatment, up to a maximum duration of approximately 25 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pazopanib
Hide Arm/Group Description Participants received matching placebo once daily for a maximum of 24 months. Pazopanib
All-Cause Mortality
Placebo Pazopanib
Affected / at Risk (%) Affected / at Risk (%)
Total   0/461 (0.00%)   3/477 (0.63%) 
Hide Serious Adverse Events
Placebo Pazopanib
Affected / at Risk (%) Affected / at Risk (%)
Total   51/461 (11.06%)   121/477 (25.37%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/461 (0.22%)  2/477 (0.42%) 
Neutropenia  1  0/461 (0.00%)  2/477 (0.42%) 
Thrombocytopenia  1  1/461 (0.22%)  4/477 (0.84%) 
Cardiac disorders     
Acute coronary syndrome  1  1/461 (0.22%)  0/477 (0.00%) 
Angina pectoris  1  0/461 (0.00%)  1/477 (0.21%) 
Bradycardia  1  0/461 (0.00%)  1/477 (0.21%) 
Cardiac failure  1  0/461 (0.00%)  1/477 (0.21%) 
Cardiomyopathy  1  0/461 (0.00%)  1/477 (0.21%) 
Coronary artery disease  1  0/461 (0.00%)  1/477 (0.21%) 
Coronary artery insufficiency  1  1/461 (0.22%)  0/477 (0.00%) 
Myocardial infarction  1  0/461 (0.00%)  2/477 (0.42%) 
Myocardial ischaemia  1  0/461 (0.00%)  1/477 (0.21%) 
Sinus bradycardia  1  0/461 (0.00%)  1/477 (0.21%) 
Ventricular tachycardia  1  0/461 (0.00%)  1/477 (0.21%) 
Ear and labyrinth disorders     
Vertigo  1  0/461 (0.00%)  1/477 (0.21%) 
Eye disorders     
Vitreous detachment  1  0/461 (0.00%)  1/477 (0.21%) 
Vitreous floaters  1  0/461 (0.00%)  1/477 (0.21%) 
Vitreous haemorrhage  1  0/461 (0.00%)  2/477 (0.42%) 
Gastrointestinal disorders     
Abdominal mass  1  1/461 (0.22%)  0/477 (0.00%) 
Abdominal pain  1  3/461 (0.65%)  3/477 (0.63%) 
Abdominal pain lower  1  0/461 (0.00%)  1/477 (0.21%) 
Abdominal pain upper  1  1/461 (0.22%)  0/477 (0.00%) 
Anal haemorrhage  1  1/461 (0.22%)  0/477 (0.00%) 
Ascites  1  1/461 (0.22%)  1/477 (0.21%) 
Constipation  1  1/461 (0.22%)  1/477 (0.21%) 
Diarrhoea  1  2/461 (0.43%)  3/477 (0.63%) 
Duodenitis  1  0/461 (0.00%)  1/477 (0.21%) 
Enterocele  1  0/461 (0.00%)  1/477 (0.21%) 
Gastric ulcer perforation  1  0/461 (0.00%)  2/477 (0.42%) 
Gastrointestinal haemorrhage  1  0/461 (0.00%)  1/477 (0.21%) 
Ileus  1  0/461 (0.00%)  2/477 (0.42%) 
Intestinal obstruction  1  3/461 (0.65%)  3/477 (0.63%) 
Large intestinal obstruction  1  1/461 (0.22%)  0/477 (0.00%) 
Nausea  1  1/461 (0.22%)  2/477 (0.42%) 
Pancreatitis acute  1  0/461 (0.00%)  1/477 (0.21%) 
Rectal haemorrhage  1  0/461 (0.00%)  1/477 (0.21%) 
Small intestinal obstruction  1  1/461 (0.22%)  1/477 (0.21%) 
Subileus  1  3/461 (0.65%)  1/477 (0.21%) 
Vomiting  1  2/461 (0.43%)  4/477 (0.84%) 
General disorders     
Asthenia  1  1/461 (0.22%)  0/477 (0.00%) 
Fatigue  1  0/461 (0.00%)  2/477 (0.42%) 
Fibrosis  1  0/461 (0.00%)  1/477 (0.21%) 
General physical health deterioration  1  1/461 (0.22%)  4/477 (0.84%) 
Hernia  1  1/461 (0.22%)  2/477 (0.42%) 
Ill-defined disorder  1  1/461 (0.22%)  0/477 (0.00%) 
Influenza like illness  1  1/461 (0.22%)  0/477 (0.00%) 
Pyrexia  1  2/461 (0.43%)  9/477 (1.89%) 
Hepatobiliary disorders     
Cholecystitis  1  0/461 (0.00%)  1/477 (0.21%) 
Cholecystitis acute  1  0/461 (0.00%)  1/477 (0.21%) 
Hepatocellular injury  1  0/461 (0.00%)  1/477 (0.21%) 
Hepatotoxicity  1  0/461 (0.00%)  3/477 (0.63%) 
Immune system disorders     
Cytokine release syndrome  1  0/461 (0.00%)  1/477 (0.21%) 
Drug hypersensitivity  1  0/461 (0.00%)  1/477 (0.21%) 
Hypersensitivity  1  0/461 (0.00%)  2/477 (0.42%) 
Sarcoidosis  1  1/461 (0.22%)  0/477 (0.00%) 
Infections and infestations     
Bronchitis  1  1/461 (0.22%)  0/477 (0.00%) 
Erysipelas  1  1/461 (0.22%)  0/477 (0.00%) 
Gastroenteritis  1  1/461 (0.22%)  1/477 (0.21%) 
Gastroenteritis norovirus  1  0/461 (0.00%)  1/477 (0.21%) 
Infected lymphocele  1  1/461 (0.22%)  1/477 (0.21%) 
Infectious colitis  1  1/461 (0.22%)  0/477 (0.00%) 
Infectious pleural effusion  1  0/461 (0.00%)  1/477 (0.21%) 
Localised infection  1  1/461 (0.22%)  0/477 (0.00%) 
Pelvic abscess  1  0/461 (0.00%)  1/477 (0.21%) 
Pharyngotonsillitis  1  0/461 (0.00%)  1/477 (0.21%) 
Pneumonia  1  0/461 (0.00%)  2/477 (0.42%) 
Pyelonephritis  1  0/461 (0.00%)  1/477 (0.21%) 
Respiratory tract infection  1  0/461 (0.00%)  1/477 (0.21%) 
Subcutaneous abscess  1  0/461 (0.00%)  1/477 (0.21%) 
Tooth abscess  1  1/461 (0.22%)  0/477 (0.00%) 
Urinary tract infection  1  3/461 (0.65%)  0/477 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/461 (0.22%)  0/477 (0.00%) 
Fall  1  1/461 (0.22%)  0/477 (0.00%) 
Incisional hernia  1  1/461 (0.22%)  0/477 (0.00%) 
Overdose  1  1/461 (0.22%)  0/477 (0.00%) 
Procedural complication  1  0/461 (0.00%)  1/477 (0.21%) 
Thermal burn  1  0/461 (0.00%)  1/477 (0.21%) 
Tibia fracture  1  1/461 (0.22%)  0/477 (0.00%) 
Upper limb fracture  1  1/461 (0.22%)  0/477 (0.00%) 
Wound dehiscence  1  0/461 (0.00%)  1/477 (0.21%) 
Investigations     
Alanine aminotransferase increased  1  0/461 (0.00%)  18/477 (3.77%) 
Aspartate aminotransferase increased  1  0/461 (0.00%)  7/477 (1.47%) 
Blood bilirubin increased  1  0/461 (0.00%)  2/477 (0.42%) 
Blood lactate dehydrogenase increased  1  0/461 (0.00%)  1/477 (0.21%) 
Ejection fraction decreased  1  0/461 (0.00%)  1/477 (0.21%) 
Electrocardiogram QT prolonged  1  1/461 (0.22%)  0/477 (0.00%) 
Electrocardiogram abnormal  1  0/461 (0.00%)  1/477 (0.21%) 
Gamma-glutamyltransferase increased  1  0/461 (0.00%)  2/477 (0.42%) 
Hepatic enzyme increased  1  0/461 (0.00%)  5/477 (1.05%) 
Liver function test abnormal  1  0/461 (0.00%)  1/477 (0.21%) 
Neutrophil count decreased  1  0/461 (0.00%)  1/477 (0.21%) 
Platelet count decreased  1  0/461 (0.00%)  1/477 (0.21%) 
Transaminases increased  1  0/461 (0.00%)  3/477 (0.63%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/461 (0.00%)  1/477 (0.21%) 
Dehydration  1  0/461 (0.00%)  1/477 (0.21%) 
Hypoglycaemia  1  0/461 (0.00%)  1/477 (0.21%) 
Hypokalaemia  1  1/461 (0.22%)  0/477 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/461 (0.00%)  1/477 (0.21%) 
Intervertebral disc protrusion  1  0/461 (0.00%)  1/477 (0.21%) 
Musculoskeletal chest pain  1  0/461 (0.00%)  1/477 (0.21%) 
Myalgia intercostal  1  0/461 (0.00%)  1/477 (0.21%) 
Rheumatoid arthritis  1  1/461 (0.22%)  0/477 (0.00%) 
Rotator cuff syndrome  1  1/461 (0.22%)  0/477 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenoma benign  1  1/461 (0.22%)  0/477 (0.00%) 
Intraductal proliferative breast lesion  1  1/461 (0.22%)  0/477 (0.00%) 
Malignant lymphoma unclassifiable low grade  1  1/461 (0.22%)  0/477 (0.00%) 
Malignant neoplasm of unknown primary site  1  0/461 (0.00%)  1/477 (0.21%) 
Metastases to abdominal cavity  1  0/461 (0.00%)  1/477 (0.21%) 
Squamous cell carcinoma of skin  1  1/461 (0.22%)  0/477 (0.00%) 
Thyroid adenoma  1  0/461 (0.00%)  1/477 (0.21%) 
Ulcerated haemangioma  1  0/461 (0.00%)  1/477 (0.21%) 
Nervous system disorders     
Cranial nerve disorder  1  1/461 (0.22%)  0/477 (0.00%) 
Headache  1  0/461 (0.00%)  2/477 (0.42%) 
Intercostal neuralgia  1  0/461 (0.00%)  1/477 (0.21%) 
Ischaemic stroke  1  0/461 (0.00%)  1/477 (0.21%) 
Migraine  1  0/461 (0.00%)  2/477 (0.42%) 
Paraesthesia  1  0/461 (0.00%)  1/477 (0.21%) 
Posterior reversible encephalopathy syndrome  1  0/461 (0.00%)  1/477 (0.21%) 
Presyncope  1  0/461 (0.00%)  1/477 (0.21%) 
Seizure  1  0/461 (0.00%)  1/477 (0.21%) 
Transverse sinus thrombosis  1  0/461 (0.00%)  1/477 (0.21%) 
Product Issues     
Device breakage  1  1/461 (0.22%)  0/477 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/461 (0.00%)  1/477 (0.21%) 
Hydronephrosis  1  2/461 (0.43%)  0/477 (0.00%) 
Urinary retention  1  1/461 (0.22%)  0/477 (0.00%) 
Urinary tract obstruction  1  0/461 (0.00%)  1/477 (0.21%) 
Reproductive system and breast disorders     
Female genital tract fistula  1  0/461 (0.00%)  1/477 (0.21%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  0/461 (0.00%)  1/477 (0.21%) 
Pleural effusion  1  1/461 (0.22%)  1/477 (0.21%) 
Pulmonary embolism  1  0/461 (0.00%)  2/477 (0.42%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  0/461 (0.00%)  1/477 (0.21%) 
Erythema multiforme  1  0/461 (0.00%)  1/477 (0.21%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/461 (0.00%)  2/477 (0.42%) 
Rash  1  0/461 (0.00%)  1/477 (0.21%) 
Vascular disorders     
Arterial thrombosis  1  0/461 (0.00%)  1/477 (0.21%) 
Hypertension  1  0/461 (0.00%)  8/477 (1.68%) 
Hypertensive crisis  1  0/461 (0.00%)  4/477 (0.84%) 
Lymphocele  1  1/461 (0.22%)  0/477 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pazopanib
Affected / at Risk (%) Affected / at Risk (%)
Total   381/461 (82.65%)   462/477 (96.86%) 
Blood and lymphatic system disorders     
Leukopenia  1  5/461 (1.08%)  44/477 (9.22%) 
Neutropenia  1  23/461 (4.99%)  103/477 (21.59%) 
Thrombocytopenia  1  8/461 (1.74%)  48/477 (10.06%) 
Endocrine disorders     
Hypothyroidism  1  15/461 (3.25%)  49/477 (10.27%) 
Gastrointestinal disorders     
Abdominal pain  1  94/461 (20.39%)  88/477 (18.45%) 
Abdominal pain upper  1  30/461 (6.51%)  67/477 (14.05%) 
Constipation  1  72/461 (15.62%)  38/477 (7.97%) 
Diarrhoea  1  79/461 (17.14%)  252/477 (52.83%) 
Dyspepsia  1  17/461 (3.69%)  24/477 (5.03%) 
Nausea  1  81/461 (17.57%)  174/477 (36.48%) 
Stomatitis  1  7/461 (1.52%)  27/477 (5.66%) 
Vomiting  1  39/461 (8.46%)  71/477 (14.88%) 
General disorders     
Asthenia  1  55/461 (11.93%)  66/477 (13.84%) 
Fatigue  1  66/461 (14.32%)  133/477 (27.88%) 
Mucosal inflammation  1  10/461 (2.17%)  32/477 (6.71%) 
Infections and infestations     
Urinary tract infection  1  33/461 (7.16%)  32/477 (6.71%) 
Viral upper respiratory tract infection  1  24/461 (5.21%)  27/477 (5.66%) 
Investigations     
Alanine aminotransferase increased  1  25/461 (5.42%)  73/477 (15.30%) 
Aspartate aminotransferase increased  1  24/461 (5.21%)  66/477 (13.84%) 
Blood alkaline phosphatase increased  1  3/461 (0.65%)  24/477 (5.03%) 
Blood bilirubin increased  1  1/461 (0.22%)  29/477 (6.08%) 
Blood thyroid stimulating hormone increased  1  1/461 (0.22%)  32/477 (6.71%) 
Neutrophil count decreased  1  11/461 (2.39%)  36/477 (7.55%) 
Platelet count decreased  1  1/461 (0.22%)  30/477 (6.29%) 
Metabolism and nutrition disorders     
Decreased appetite  1  15/461 (3.25%)  79/477 (16.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  68/461 (14.75%)  71/477 (14.88%) 
Back pain  1  38/461 (8.24%)  30/477 (6.29%) 
Muscle spasms  1  20/461 (4.34%)  35/477 (7.34%) 
Myalgia  1  34/461 (7.38%)  45/477 (9.43%) 
Pain in extremity  1  18/461 (3.90%)  38/477 (7.97%) 
Nervous system disorders     
Dizziness  1  22/461 (4.77%)  26/477 (5.45%) 
Dysgeusia  1  13/461 (2.82%)  95/477 (19.92%) 
Headache  1  70/461 (15.18%)  135/477 (28.30%) 
Psychiatric disorders     
Insomnia  1  27/461 (5.86%)  24/477 (5.03%) 
Renal and urinary disorders     
Proteinuria  1  8/461 (1.74%)  40/477 (8.39%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  20/461 (4.34%)  24/477 (5.03%) 
Dyspnoea  1  21/461 (4.56%)  31/477 (6.50%) 
Skin and subcutaneous tissue disorders     
Hair colour changes  1  8/461 (1.74%)  95/477 (19.92%) 
Palmar-plantar erythrodysaesthesia syndrome  1  7/461 (1.52%)  61/477 (12.79%) 
Rash  1  22/461 (4.77%)  42/477 (8.81%) 
Vascular disorders     
Hot flush  1  29/461 (6.29%)  23/477 (4.82%) 
Hypertension  1  87/461 (18.87%)  256/477 (53.67%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
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
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Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00866697    
Other Study ID Numbers: 110655
2008-004672-50 ( EudraCT Number )
CPZP034C2301 ( Other Identifier: Novartis )
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: July 3, 2013
Results First Posted: December 19, 2013
Last Update Posted: February 16, 2021