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Pazopanib Versus Sunitinib in the Treatment of Asian Subjects With Locally Advanced and/or Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01147822
Recruitment Status : Active, not recruiting
First Posted : June 22, 2010
Results First Posted : March 15, 2013
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Renal Cell
Interventions Drug: Pazopanib
Drug: Sunitinib
Enrollment 183
Recruitment Details Study VEG113078 is a substudy of Study VEG108844 (NCT00720941). Due to the projected limited enrollment of Asian participants into Study VEG108844, Study VEG113078 was designed to evaluate the efficacy and safety of pazopanib versus sunitinib for the treatment of Asian participants (par.) enrolled from selected Far-East Asian countries.
Pre-assignment Details Par. from China, Korea, and Taiwan who enrolled in either Study VEG108844 or VEG113078 and par. from Japan who enrolled in Study VEG108844 were pooled for analysis of the Asian population, presented in this report. Only 183 participants were enrolled in Study VEG113078 (as reflected in the Enrollment field in the Protocol record).
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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Period Title: Overall Study
Started 188 179
Not Completed/Ongoing 111 102
Completed 0 0
Not Completed 188 179
Reason Not Completed
Death             66             59
Protocol Violation             0             1
Lost to Follow-up             3             2
Physician Decision             0             2
Withdrawal by Subject             8             13
Not Completed/Ongoing             111             102
Arm/Group Title Pazopanib 800 mg Sunitinib 50 mg Total
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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Total of all reporting groups
Overall Number of Baseline Participants 188 179 367
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 188 participants 179 participants 367 participants
57.7  (11.51) 57.6  (11.19) 57.6  (11.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 179 participants 367 participants
Female
51
  27.1%
42
  23.5%
93
  25.3%
Male
137
  72.9%
137
  76.5%
274
  74.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 188 participants 179 participants 367 participants
Asian - Central/South Asian Heritage 2 1 3
Asian - East Asian Heritage 154 144 298
Asian - Japanese Heritage 29 31 60
Asian - South East Asian Heritage 3 3 6
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 (LD) recorded since the treatment started or the appearance of >=1 new lesion. 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.
Time Frame From randomization to the earliest date of disease progression or death (up to 39 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population (Asian): All randomized participants (par) from Study VEG113078 and Study VEG108844 who enrolled in Japan, China, Taiwan, and Korea.
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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Overall Number of Participants Analyzed 188 179
Median (95% Confidence Interval)
Unit of Measure: Months
8.4
(8.3 to 11.1)
11.1
(8.2 to 14.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pazopanib 800 mg, Sunitinib 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0184
Confidence Interval (2-Sided) 95%
0.7658 to 1.3542
Estimation Comments The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off.
Time Frame From randomization until death (up to 44 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Asian)
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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Overall Number of Participants Analyzed 188 179
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(23.7 to NA)
31.5 [2] 
(29.5 to NA)
[1]
An insufficient number of participants were followed until death; thus, the median could not be calculated. An insufficient number of participants were followed until death; thus, the upper limit of the confidence interval could not be calculated.
[2]
An insufficient number of participants were followed until death; thus, the upper limit of the confidence interval could not be calculated.
3.Secondary Outcome
Title Number of Participants With a Best Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the IRC
Hide Description The number of participants with evidence of CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 millimeters [mm] in the short axis) or 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) was evaluated by an independent review per RECIST, Version 1.
Time Frame From Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Asian)
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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Overall Number of Participants Analyzed 188 179
Measure Type: Number
Unit of Measure: Participants
Complete Response 1 0
Partial Response 66 37
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 confirmed CR (the disappearance of all target lesions. Any pathological lymph node must be less than 10 mm in the short axis) 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 Baseline until the time of response or the earliest date of disease progression/death (up to 39 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Asian). 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 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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Overall Number of Participants Analyzed 67 37
Median (95% Confidence Interval)
Unit of Measure: Weeks
11.9
(6.7 to 12.3)
17.9
(12.0 to 23.9)
5.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR is defined as the time from the first documented evidence of confirmed 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 lesions. Any pathological lymph node must be less than 10 mm in the short axis. 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 response until the earliest date of disease progression/death (up to 38 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Asian). 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 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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
Overall Number of Participants Analyzed 67 37
Median (95% Confidence Interval)
Unit of Measure: Months
15.2
(9.9 to 17.9)
18.0 [1] 
(12.3 to NA)
[1]
An insufficient number of responders were followed until progression to observe the end of response; thus, the upper limit of the confidence interval could not be calculated.
Time Frame Participants were analyzed from the first dose of study medication until the follow-up contact (up to Study Week 156).
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 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. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason. Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
All-Cause Mortality
Pazopanib 800 mg Sunitinib 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pazopanib 800 mg Sunitinib 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   68/186 (36.56%)   73/177 (41.24%) 
Blood and lymphatic system disorders     
Anemia  1  4/186 (2.15%)  4/177 (2.26%) 
Febrile neutropenia  1  2/186 (1.08%)  0/177 (0.00%) 
Thrombocytopenia  1  2/186 (1.08%)  15/177 (8.47%) 
Neutropenia  1  1/186 (0.54%)  5/177 (2.82%) 
Lymphopenia  1  0/186 (0.00%)  1/177 (0.56%) 
Cardiac disorders     
Cardiac failure congestive  1  1/186 (0.54%)  0/177 (0.00%) 
Cardiopulmonary failure  1  1/186 (0.54%)  0/177 (0.00%) 
Angina unstable  1  0/186 (0.00%)  1/177 (0.56%) 
Ear and labyrinth disorders     
Sudden hearing loss  1  0/186 (0.00%)  1/177 (0.56%) 
Gastrointestinal disorders     
Diarrhea  1  2/186 (1.08%)  1/177 (0.56%) 
Ileus  1  2/186 (1.08%)  0/177 (0.00%) 
Anal fistula  1  1/186 (0.54%)  0/177 (0.00%) 
Ascites  1  1/186 (0.54%)  0/177 (0.00%) 
Colonic polyp  1  1/186 (0.54%)  0/177 (0.00%) 
Duodenal ulcer  1  1/186 (0.54%)  0/177 (0.00%) 
Enterocolitis  1  1/186 (0.54%)  0/177 (0.00%) 
Gastritis erosive  1  1/186 (0.54%)  0/177 (0.00%) 
Lower gastrointestinal hemorrhage  1  1/186 (0.54%)  0/177 (0.00%) 
Nausea  1  1/186 (0.54%)  0/177 (0.00%) 
Small intestinal hemorrhage  1  1/186 (0.54%)  0/177 (0.00%) 
Upper gastrointestinal hemorrhage  1  1/186 (0.54%)  2/177 (1.13%) 
Vomiting  1  1/186 (0.54%)  0/177 (0.00%) 
Abdominal distension  1  0/186 (0.00%)  1/177 (0.56%) 
Gastritis  1  0/186 (0.00%)  1/177 (0.56%) 
Gastrointestinal hemorrhage  1  0/186 (0.00%)  1/177 (0.56%) 
Pancreatitis acute  1  0/186 (0.00%)  1/177 (0.56%) 
General disorders     
Pyrexia  1  3/186 (1.61%)  7/177 (3.95%) 
Disease progression  1  1/186 (0.54%)  0/177 (0.00%) 
Fatigue  1  1/186 (0.54%)  4/177 (2.26%) 
Pain  1  1/186 (0.54%)  0/177 (0.00%) 
Asthenia  1  0/186 (0.00%)  2/177 (1.13%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  6/186 (3.23%)  3/177 (1.69%) 
Cholecystitis acute  1  1/186 (0.54%)  0/177 (0.00%) 
Drug-induced liver injury  1  1/186 (0.54%)  1/177 (0.56%) 
Cholecystitis  1  0/186 (0.00%)  1/177 (0.56%) 
Hepatitis  1  0/186 (0.00%)  1/177 (0.56%) 
Hyperbilirubinemia  1  0/186 (0.00%)  2/177 (1.13%) 
Infections and infestations     
Pneumonia  1  2/186 (1.08%)  1/177 (0.56%) 
Appendicitis  1  1/186 (0.54%)  1/177 (0.56%) 
Cellulitis  1  1/186 (0.54%)  0/177 (0.00%) 
H1N1 influenza  1  1/186 (0.54%)  0/177 (0.00%) 
Infection  1  1/186 (0.54%)  0/177 (0.00%) 
Lung infection  1  1/186 (0.54%)  0/177 (0.00%) 
Septic shock  1  1/186 (0.54%)  0/177 (0.00%) 
Gastroenteritis  1  0/186 (0.00%)  1/177 (0.56%) 
Herpes zoster  1  0/186 (0.00%)  1/177 (0.56%) 
Perinephric abscess  1  0/186 (0.00%)  1/177 (0.56%) 
Peritonitis  1  0/186 (0.00%)  1/177 (0.56%) 
Pneumonia bacterial  1  0/186 (0.00%)  1/177 (0.56%) 
Retroperitoneal abscess  1  0/186 (0.00%)  1/177 (0.56%) 
Injury, poisoning and procedural complications     
Brain herniation  1  1/186 (0.54%)  0/177 (0.00%) 
Contusion  1  1/186 (0.54%)  0/177 (0.00%) 
Fracture  1  0/186 (0.00%)  1/177 (0.56%) 
Patella fracture  1  0/186 (0.00%)  1/177 (0.56%) 
Investigations     
Alanine aminotransferase increased  1  11/186 (5.91%)  3/177 (1.69%) 
Aspartate aminotransferase increased  1  4/186 (2.15%)  0/177 (0.00%) 
Lipase increased  1  4/186 (2.15%)  3/177 (1.69%) 
Neutrophil count decreased  1  2/186 (1.08%)  0/177 (0.00%) 
Blood bilirubin increased  1  1/186 (0.54%)  1/177 (0.56%) 
Blood glucose decreased  1  1/186 (0.54%)  0/177 (0.00%) 
Blood potassium increased  1  1/186 (0.54%)  0/177 (0.00%) 
Gamma-glutamyltransferase increased  1  1/186 (0.54%)  0/177 (0.00%) 
Liver function test abnormal  1  1/186 (0.54%)  0/177 (0.00%) 
Amylase increased  1  0/186 (0.00%)  1/177 (0.56%) 
Blood calcium increased  1  0/186 (0.00%)  1/177 (0.56%) 
Blood creatine phosphokinase increased  1  0/186 (0.00%)  1/177 (0.56%) 
Blood magnesium decreased  1  0/186 (0.00%)  1/177 (0.56%) 
Platelet count decreased  1  0/186 (0.00%)  7/177 (3.95%) 
Metabolism and nutrition disorders     
Hyponatremia  1  3/186 (1.61%)  2/177 (1.13%) 
Decreased appetite  1  2/186 (1.08%)  0/177 (0.00%) 
Hypercalcemia  1  1/186 (0.54%)  0/177 (0.00%) 
Hyperlipasemia  1  1/186 (0.54%)  0/177 (0.00%) 
Hyperuricemia  1  1/186 (0.54%)  2/177 (1.13%) 
Hypocalcemia  1  1/186 (0.54%)  0/177 (0.00%) 
Hyperkalemia  1  0/186 (0.00%)  1/177 (0.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/186 (0.54%)  0/177 (0.00%) 
Back pain  1  1/186 (0.54%)  2/177 (1.13%) 
Bone pain  1  1/186 (0.54%)  0/177 (0.00%) 
Flank pain  1  1/186 (0.54%)  1/177 (0.56%) 
Pain in extremity  1  1/186 (0.54%)  1/177 (0.56%) 
Fistula  1  0/186 (0.00%)  1/177 (0.56%) 
Musculoskeletal pain  1  0/186 (0.00%)  1/177 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  2/186 (1.08%)  0/177 (0.00%) 
Cancer pain  1  1/186 (0.54%)  0/177 (0.00%) 
Metastases to central nervous system  1  1/186 (0.54%)  0/177 (0.00%) 
Tumour rupture  1  1/186 (0.54%)  0/177 (0.00%) 
Gastric cancer  1  0/186 (0.00%)  1/177 (0.56%) 
Tumour hemorrhage  1  0/186 (0.00%)  1/177 (0.56%) 
Nervous system disorders     
Cerebral hemorrhage  1  1/186 (0.54%)  0/177 (0.00%) 
Hemorrhage intracranial  1  1/186 (0.54%)  0/177 (0.00%) 
Subarachnoid hemorrhage  1  0/186 (0.00%)  1/177 (0.56%) 
Syncope  1  0/186 (0.00%)  1/177 (0.56%) 
Tremor  1  0/186 (0.00%)  1/177 (0.56%) 
Central nervous system hemorrhage  1  0/186 (0.00%)  1/177 (0.56%) 
Cerebral infarction  1  0/186 (0.00%)  1/177 (0.56%) 
Hemorrhagic cerebral infarction  1  0/186 (0.00%)  1/177 (0.56%) 
Psychiatric disorders     
Mental status changes  1  1/186 (0.54%)  0/177 (0.00%) 
Renal and urinary disorders     
Hematuria  1  0/186 (0.00%)  1/177 (0.56%) 
Renal failure  1  0/186 (0.00%)  1/177 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Pleuritic pain  1  1/186 (0.54%)  0/177 (0.00%) 
Pulmonary embolism  1  1/186 (0.54%)  0/177 (0.00%) 
Respiratory failure  1  1/186 (0.54%)  2/177 (1.13%) 
Hiccups  1  0/186 (0.00%)  1/177 (0.56%) 
Laryngeal hemorrhage  1  0/186 (0.00%)  1/177 (0.56%) 
Pleural effusion  1  0/186 (0.00%)  4/177 (2.26%) 
Pneumonia aspiration  1  0/186 (0.00%)  1/177 (0.56%) 
Pneumonitis  1  0/186 (0.00%)  1/177 (0.56%) 
Pneumothorax  1  0/186 (0.00%)  1/177 (0.56%) 
Pulmonary artery thrombosis  1  0/186 (0.00%)  1/177 (0.56%) 
Vascular disorders     
Deep vein thrombosis  1  1/186 (0.54%)  0/177 (0.00%) 
Hypertension  1  1/186 (0.54%)  2/177 (1.13%) 
Arterial rupture  1  0/186 (0.00%)  1/177 (0.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events 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   182/186 (97.85%)   173/177 (97.74%) 
Blood and lymphatic system disorders     
Neutropenia  1  43/186 (23.12%)  75/177 (42.37%) 
Leukopenia  1  40/186 (21.51%)  59/177 (33.33%) 
Thrombocytopenia  1  29/186 (15.59%)  79/177 (44.63%) 
Anemia  1  10/186 (5.38%)  48/177 (27.12%) 
Lymphopenia  1  3/186 (1.61%)  11/177 (6.21%) 
Endocrine disorders     
Hypothyroidism  1  29/186 (15.59%)  50/177 (28.25%) 
Hyperthyroidism  1  3/186 (1.61%)  11/177 (6.21%) 
Eye disorders     
Eyelid oedema  1  17/186 (9.14%)  29/177 (16.38%) 
Gastrointestinal disorders     
Diarrhea  1  100/186 (53.76%)  81/177 (45.76%) 
Nausea  1  44/186 (23.66%)  40/177 (22.60%) 
Vomiting  1  39/186 (20.97%)  26/177 (14.69%) 
Abdominal pain upper  1  29/186 (15.59%)  21/177 (11.86%) 
Stomatitis  1  25/186 (13.44%)  53/177 (29.94%) 
Abdominal pain  1  18/186 (9.68%)  15/177 (8.47%) 
Dyspepsia  1  18/186 (9.68%)  23/177 (12.99%) 
Mouth ulceration  1  17/186 (9.14%)  27/177 (15.25%) 
Constipation  1  14/186 (7.53%)  31/177 (17.51%) 
Abdominal discomfort  1  12/186 (6.45%)  16/177 (9.04%) 
Gingivitis  1  12/186 (6.45%)  8/177 (4.52%) 
Abdominal distension  1  10/186 (5.38%)  10/177 (5.65%) 
Gingival bleeding  1  6/186 (3.23%)  9/177 (5.08%) 
Toothache  1  5/186 (2.69%)  9/177 (5.08%) 
General disorders     
Fatigue  1  78/186 (41.94%)  89/177 (50.28%) 
Pyrexia  1  18/186 (9.68%)  25/177 (14.12%) 
Mucosal inflammation  1  12/186 (6.45%)  20/177 (11.30%) 
Oedema peripheral  1  12/186 (6.45%)  20/177 (11.30%) 
Oedema  1  8/186 (4.30%)  17/177 (9.60%) 
Face oedema  1  7/186 (3.76%)  32/177 (18.08%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  17/186 (9.14%)  10/177 (5.65%) 
Infections and infestations     
Nasopharyngitis  1  15/186 (8.06%)  19/177 (10.73%) 
Upper respiratory tract infection  1  9/186 (4.84%)  11/177 (6.21%) 
Investigations     
Aspartate aminotransferase increased  1  74/186 (39.78%)  59/177 (33.33%) 
Alanine aminotransferase increased  1  71/186 (38.17%)  55/177 (31.07%) 
Blood bilirubin increased  1  34/186 (18.28%)  26/177 (14.69%) 
Blood creatinine increased  1  31/186 (16.67%)  48/177 (27.12%) 
Platelet count decreased  1  30/186 (16.13%)  58/177 (32.77%) 
Blood lactate dehydrogenase increased  1  26/186 (13.98%)  43/177 (24.29%) 
Neutrophil count decreased  1  25/186 (13.44%)  47/177 (26.55%) 
White blood cell count decreased  1  24/186 (12.90%)  52/177 (29.38%) 
Haemoglobin decreased  1  21/186 (11.29%)  48/177 (27.12%) 
Amylase increased  1  20/186 (10.75%)  13/177 (7.34%) 
Lipase increased  1  20/186 (10.75%)  18/177 (10.17%) 
Blood alkaline phosphatase increased  1  19/186 (10.22%)  12/177 (6.78%) 
Bilirubin conjugated increased  1  17/186 (9.14%)  6/177 (3.39%) 
Blood thyroid stimulating hormone increased  1  17/186 (9.14%)  32/177 (18.08%) 
Blood triglycerides increased  1  17/186 (9.14%)  22/177 (12.43%) 
Gamma-glutamyltransferase increased  1  17/186 (9.14%)  6/177 (3.39%) 
Weight decreased  1  17/186 (9.14%)  5/177 (2.82%) 
Blood bilirubin unconjugated increased  1  16/186 (8.60%)  8/177 (4.52%) 
Blood albumin decreased  1  12/186 (6.45%)  14/177 (7.91%) 
Blood urea increased  1  9/186 (4.84%)  12/177 (6.78%) 
Blood glucose increased  1  8/186 (4.30%)  10/177 (5.65%) 
Blood phosphorus decreased  1  8/186 (4.30%)  11/177 (6.21%) 
Haematocrit decreased  1  6/186 (3.23%)  12/177 (6.78%) 
Red blood cell count decreased  1  2/186 (1.08%)  9/177 (5.08%) 
Xanthochromia  1  1/186 (0.54%)  10/177 (5.65%) 
Metabolism and nutrition disorders     
Decreased appetite  1  77/186 (41.40%)  66/177 (37.29%) 
Hyponatremia  1  11/186 (5.91%)  16/177 (9.04%) 
Hypophosphatemia  1  11/186 (5.91%)  16/177 (9.04%) 
Hyperglycemia  1  8/186 (4.30%)  15/177 (8.47%) 
Hypoalbuminemia  1  4/186 (2.15%)  11/177 (6.21%) 
Hypocalcemia  1  2/186 (1.08%)  11/177 (6.21%) 
Hyperuricemia  1  0/186 (0.00%)  9/177 (5.08%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  21/186 (11.29%)  17/177 (9.60%) 
Myalgia  1  14/186 (7.53%)  12/177 (6.78%) 
Arthralgia  1  13/186 (6.99%)  10/177 (5.65%) 
Pain in extremity  1  13/186 (6.99%)  18/177 (10.17%) 
Flank pain  1  0/186 (0.00%)  9/177 (5.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hypogeusia  1  9/186 (4.84%)  12/177 (6.78%) 
Nervous system disorders     
Headache  1  27/186 (14.52%)  20/177 (11.30%) 
Dysgeusia  1  25/186 (13.44%)  37/177 (20.90%) 
Dizziness  1  16/186 (8.60%)  17/177 (9.60%) 
Psychiatric disorders     
Insomnia  1  10/186 (5.38%)  14/177 (7.91%) 
Renal and urinary disorders     
Proteinuria  1  60/186 (32.26%)  53/177 (29.94%) 
Haematuria  1  8/186 (4.30%)  10/177 (5.65%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  20/186 (10.75%)  23/177 (12.99%) 
Epistaxis  1  14/186 (7.53%)  27/177 (15.25%) 
Dysphonia  1  13/186 (6.99%)  4/177 (2.26%) 
Oropharyngeal pain  1  11/186 (5.91%)  14/177 (7.91%) 
Dyspnoea  1  8/186 (4.30%)  19/177 (10.73%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  1  93/186 (50.00%)  114/177 (64.41%) 
Hair colour changes  1  67/186 (36.02%)  14/177 (7.91%) 
Rash  1  27/186 (14.52%)  35/177 (19.77%) 
Alopecia  1  23/186 (12.37%)  11/177 (6.21%) 
Skin hypopigmentation  1  16/186 (8.60%)  4/177 (2.26%) 
Pruritus  1  4/186 (2.15%)  16/177 (9.04%) 
Yellow skin  1  4/186 (2.15%)  43/177 (24.29%) 
Vascular disorders     
Hypertension  1  103/186 (55.38%)  94/177 (53.11%) 
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
Name/Title: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01147822     History of Changes
Other Study ID Numbers: 113078
First Submitted: May 20, 2010
First Posted: June 22, 2010
Results First Submitted: January 18, 2013
Results First Posted: March 15, 2013
Last Update Posted: February 21, 2018