A Study to Evaluate Pazopanib as an Adjuvant Treatment fo... | NCT01235962 | Trialant
NCT01235962
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Nov 23, 2020Actual
Enrollment
1,538Actual
Phase
Phase 3
Conditions
Renal Cell Carcinoma (RCC)
Cancer
Interventions
pazopanib
placebo
pazopanib
placebo
Countries
United States
Argentina
Austria
Belgium
Brazil
Canada
Chile
China
Czechia
Denmark
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Japan
Luxembourg
Poland
Russia
Slovakia
South Korea
Spain
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01235962
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
113387
Secondary IDs
ID
Type
Description
Link
2010-020965-26
EudraCT Number
CPZP034D2301
Other Identifier
Novartis
Brief Title
A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC)
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy
Acronym
PROTECT
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 30, 2010Actual
Primary Completion Date
Oct 15, 2015Actual
Completion Date
Apr 15, 2019Actual
First Submitted Date
Oct 14, 2010
First Submission Date that Met QC Criteria
Nov 4, 2010
First Posted Date
Nov 8, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 15, 2020
Results First Submitted that Met QC Criteria
Oct 29, 2020
Results First Posted Date
Nov 23, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 26, 2017
Certification/Extension First Submitted that Passed QC Review
Jan 26, 2017
Certification/Extension First Posted Date
Jan 27, 2017Estimated
Last Update Submitted Date
Oct 29, 2020
Last Update Posted Date
Nov 23, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.
Detailed Description
The primary objective of this ongoing study was to evaluate DFS with pazopanib 600 mg daily initial dose as compared with placebo as adjuvant therapy for subjects with localized/locally advanced RCC following nephrectomy.
Subjects with locally recurrent renal cell carcinoma (RCC), bilateral RCC, or history of another malignancy were excluded from enrolling in the study.
The study was comprised of three successive study periods: 1) the Screening/Baseline period, 2) the study treatment period, and 3) the DFS /OS follow-up period. The Screening/Baseline period had a maximum duration of 12 weeks from the date of nephrectomy to the date of randomization.
After a subject met all the eligibility criteria and completed all the required baseline assessments, the subject was randomized in a 1:1 ratio to receive once daily blinded treatment with either pazopanib 600 mg as initial dose or matching placebo based on pre-defined stratification factors.
Subjects received continuous daily treatment until completion of the 12-month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed. During the study treatment and DFS follow-up periods, subjects received routine safety and efficacy assessments.
The study treatment period was 12 months. Subjects received continuous daily treatment until completion of the 12 month treatment period, disease recurrence, or unacceptable toxicity/intolerance. Subsequent adjuvant therapies for RCC were not allowed.
All subjects, regardless of study treatment status (i.e. premature discontinuation or completion of the 12-month treatment), were to be followed with routine imaging assessments and remain blinded until objective evidence of disease recurrence was obtained or until the study achieved the required number of events for the primary endpoint of DFS (319 events). After objective evidence of disease recurrence was obtained, subjects could be unblinded and received the first-line treatment for metastatic RCC per local standard of care.
All subjects were off treatment for at least 4 years at the end of study.
Conditions Module
Conditions
Renal Cell Carcinoma (RCC)
Cancer
Keywords
anti-angiogenic agent
renal cell carcinoma
pazopanib
adjuvant therapy
VEGFR inhibitor
localized or locally
advanced renal cell carcinoma (RCC) following nephrectomy
advanced RCC
Cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,538Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
pazopanib
Experimental
Pazopanib oral agent, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Drug: pazopanib
placebo
Placebo Comparator
placebo matching pazopanib 200 mg tablets, administered at 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months. Dose can be reduced, interrupted or discontinued due to adverse events or intolerance.
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
pazopanib
Drug
Pazopanib monohydrochloride salt was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Disease-free Survival (DFS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS) With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Overall survival is defined as the time from randomization until death due to any cause.
For subjects who did not die, time to death was censored at the last date of known contact.
approximately 8.5 years
DFS Rates at Yearly Time Points With Pazopanib 600 mg Daily Initial Dose vs. Placebo
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
Diagnosis of RCC with clear-cell or predominant clear-cell histology
Subjects with non-metastatic disease (M0) fulfilling any of the following combinations of pathologic staging based on American Joint Committee on Cancer (AJCC) TNM staging version 2010 and Fuhrman nuclear grading.
pT2, G3 or G4, N0; or,
pT3, G any, N0; or,
pT4, G any, N0; or,
pT any, G any, N1
Fulfill all of the following criteria of disease-free status at baseline:
Had complete gross surgical resection of all RCC via radical or partial nephrectomy using either open or laparoscopic technique.
Baseline imaging of chest, abdomen and pelvis shows no metastasis or residual tumor lesions as confirmed centrally by an independent radiologist.
Received no prior adjuvant or neo-adjuvant treatment for RCC
Recovered from nephrectomy: any surgery related toxicities should be reduced to ≤ grade 1 per NCI Common Terminology Criteria for Adverse Events (CTCAE) (Version 4)
Karnofsky performance scale (KPS) of ≥ 80
Adequate organ system function
Exclusion Criteria:
History of another malignancy. Exception: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
Active peptic ulcer disease
Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
Active diarrhea of any grade
Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
Malabsorption syndrome
Major resection of the stomach or small bowel
History of human immunodeficiency virus (HIV) infection
History of active hepatitis
Presence of uncontrolled infection.
History of any one or more of the following cardiovascular conditions within the past 6 months:
Cardiac angioplasty or stenting
Myocardial infarction
Unstable angina
Coronary artery bypass graft surgery
Symptomatic peripheral vascular disease
History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg.
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study (see Section 7.6.2 for instruction on blood pressure measurement and obtaining mean blood pressure values).
Evidence of active bleeding or bleeding diathesis
Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
Unable or unwilling to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study treatment and for the duration of the study.
Concurrent therapy given to treat cancer including treatment with an investigational agent or concurrent participation in another clinical trial involving anti-cancer investigational drug.
Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or excipients that in the opinion of the investigator contraindicates their participation.
Prior or current use of systemic anti-VEGF inhibitors, cytokines (e.g. interferon, interleukin 2).
Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Placebo matching pazopanib was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
placebo
pazopanib
Drug
Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
pazopanib
Votrient
placebo
Drug
placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
placebo
yearly for 4 years
DFS With Pazopanib vs. Placebo
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years
OS With Pazopanib vs. Placebo
Overall survival is defined as the time from randomization until death due to any cause.
For subjects who do not die, time to death will be censored at the last date of known contact.
approximately 8.5 years
DFS Rates at Yearly Time Points With Pazopanib vs. Placebo
yearly for 4 years
DFS Pazopanib 800 mg Daily Initial Dose vs. Placebo
DFS is defined as the interval between the date of randomization and the earliest date of disease recurrence/metastasis or death due to any cause.
approximately 5 years
OS With Pazopanib 800 mg Daily Initial Dose vs. Placebo
Overall survival is defined as the time from randomization until death due to any cause.
For subjects who did not die, time to death was censored at the last date of known contact.
approximately 8.5 years
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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). A negative mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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-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 mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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). A negative mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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). A negative mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score
Health outcome and quality of life measured by EQ-5D thermometer (thermo) score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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). A negative mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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-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 mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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). A negative mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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). A negative mean indicates a worsening of condition.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score
Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Motzer RJ, Russo P, Haas N, Doehn C, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Lim HY, Melichar B, Zemanova M, Rini B, Choueiri TK, Wood L, Reaume MN, Stenzl A, Chowdhury S, McDermott R, Michael A, Izquierdo M, Aimone P, Zhang H, Sternberg CN; PROTECT study investigators. Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial. Eur Urol. 2021 Mar;79(3):334-338. doi: 10.1016/j.eururo.2020.12.029. Epub 2021 Jan 15.
FG002
ITT Pazopanib 600 mg
Pazopanib 600 mg daily initial dose for 8-12 weeks. Dose can be escalated to 800 mg daily based on safety evaluation. Complete treatment is 12 months.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/Functional Assessment of Cancer Therapy-Kidney Symptom Index -19 (FACT FKSI-19) Total Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up
ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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). A negative mean indicates a worsening of condition.
ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Disease Related Symptoms-emotional (DRS-E) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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-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 mean indicates a worsening of condition.
ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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). A negative mean indicates a worsening of condition.
ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using NCCN/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. 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). A negative mean indicates a worsening of condition.
ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.
Health-related Quality of Life (HRQoL) With Pazopanib 600 mg Daily Initial Dose vs. Placebo Assessed Using EuroQoL-5D (EQ-5D) Score
Health outcome and quality of life measured by EQ-5D thermometer (thermo) score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
ITT 600 included all randomized subjects with a scheduled initial dose of 600 mg daily.
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Total Score
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (FKSI-DRS-P, FKSI-DRS-E, FKSI-TSE, FKSI-FWB) experienced in the past 7 days. 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). A negative mean indicates a worsening of condition. DFS: disease-free survival; FU: follow up
Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
OG001
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Secondary
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-physical (DRS-P) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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). A negative mean indicates a worsening of condition.
Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
OG001
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Secondary
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Disease-related Symptoms-emotional (DRS-E) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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-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 mean indicates a worsening of condition.
Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
OG001
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Secondary
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Treatment Side Effects (TSE) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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). A negative mean indicates a worsening of condition.
Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
OG001
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Secondary
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using National Comprehensive Cancer Network (NCCN)/FACT FKSI-19 Scale Functional Well Being (FWB) Domain Score
Health outcome and quality of life measured by NCCN/FACT FKSI-19 questionnaire for ITT ALL. 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). A negative mean indicates a worsening of condition.
Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
OG001
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Secondary
Health-related Quality of Life (HRQoL) With Pazopanib vs. Placebo for ITT ALL Assessed Using EuroQoL-5D (EQ-5D) Score
Health outcome and quality of life measured by using EQ-5D thermometer score and EQ-5D utility index (UI) score. The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Total (ITT All) included all randomized subjects, i.e. subjects either with a scheduled initial dose of 600 or 800 mg daily.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
OG001
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
Units
Post-Hoc
All Collected Deaths
On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months). Deaths post treatment survival follow up were collected after the on-treatment period, up to approx. 8.5 years. Participants who had not died after study drug discontinuation were censored: 82% of participants in the ITT 600 population and 78% of participants in the ITT 800 population.
Safety 800: subjects who received at least one dose of study treatment in the ITT 800 population Safety 600: subjects who received at least one dose of study treatment in the ITT 600 population
Posted
Number
participants
approx. 13 months, approx. 8.5 years
ID
Title
Description
OG000
Safety Pazopanib 800 mg
Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
OG001
Safety Placebo 800 mg
Placebo matching pazopanib 800 mg daily based on safety evaluation. Complete treatment is 12 months.
OG002
Safety Pazopanib 600 mg
Pazopanib 600 mg daily dose based on safety evaluation. Complete treatment is 12 months.
Time Frame
On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of approx. 13 months (treatment duration ranged from 0 to to 13 months).
Description
Adverse Event: Any sign or symptom that occurs during the study treatment plus up to 28 days post treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ITT Pazopanib 800 mg
Pazopanib 800 mg daily dose based on safety evaluation. Complete treatment is 12 months.
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily pazopanib.
4
766
167
766
735
766
EG005
ITT All - Placebo
All randomized subjects with a scheduled initial dose of 600 or 800 mg daily placebo.
0
762
68
762
595
762
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG0032 affected558 at risk
EG0041 affected766 at risk
EG0052 affected762 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0012 affected204 at risk
EG0020 affected568 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Macular hole
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Retinal tear
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Visual impairment
Eye disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0023 affected568 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0021 affected568 at risk
EG003
Chest pain
General disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0012 affected204 at risk
EG0021 affected568 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0021 affected568 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0005 affected198 at risk
EG0010 affected204 at risk
EG0023 affected568 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Lung transplant rejection
Immune system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Appendiceal abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Cystitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Diabetic gangrene
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Sepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0021 affected568 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Viral infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Pubis fracture
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG00015 affected198 at risk
EG0010 affected204 at risk
EG00251 affected568 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG00212 affected568 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0023 affected568 at risk
EG003
Blood glucose increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0024 affected568 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Lipase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Transaminases increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0023 affected568 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0023 affected568 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Biliary neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Gallbladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Ovarian epithelial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Tumour thrombosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Brain hypoxia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Seizure
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Syncope
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Depression
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Panic disorder
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Renal tubular necrosis
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Alveolitis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0011 affected204 at risk
EG0020 affected568 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0022 affected568 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0003 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0002 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0001 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hypotension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0020 affected568 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG0000 affected198 at risk
EG0010 affected204 at risk
EG0021 affected568 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG00012 affected198 at risk
EG0010 affected204 at risk
EG00225 affected568 at risk
EG0032 affected558 at risk
EG00437 affected766 at risk
EG0052 affected762 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (20.1)
Systematic Assessment
EG00012 affected198 at risk
EG0011 affected204 at risk
EG00222 affected568 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (20.1)
Systematic Assessment
EG00024 affected198 at risk
EG0012 affected204 at risk
EG00255 affected568 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00027 affected198 at risk
EG00124 affected204 at risk
EG00285 affected568 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00018 affected198 at risk
EG0015 affected204 at risk
EG00258 affected568 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00017 affected198 at risk
EG00117 affected204 at risk
EG00228 affected568 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG000129 affected198 at risk
EG00148 affected204 at risk
EG002361 affected568 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00017 affected198 at risk
EG00113 affected204 at risk
EG00243 affected568 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG0008 affected198 at risk
EG0016 affected204 at risk
EG00232 affected568 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00089 affected198 at risk
EG00128 affected204 at risk
EG002226 affected568 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00023 affected198 at risk
EG00110 affected204 at risk
EG00255 affected568 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (20.1)
Systematic Assessment
EG00037 affected198 at risk
EG0018 affected204 at risk
EG00295 affected568 at risk
EG003
Asthenia
General disorders
MedDRA (20.1)
Systematic Assessment
EG00024 affected198 at risk
EG00112 affected204 at risk
EG00279 affected568 at risk
EG003
Fatigue
General disorders
MedDRA (20.1)
Systematic Assessment
EG00074 affected198 at risk
EG00153 affected204 at risk
EG002222 affected568 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (20.1)
Systematic Assessment
EG00021 affected198 at risk
EG0015 affected204 at risk
EG00246 affected568 at risk
EG003
Oedema peripheral
General disorders
MedDRA (20.1)
Systematic Assessment
EG00012 affected198 at risk
EG00110 affected204 at risk
EG00217 affected568 at risk
EG003
Pyrexia
General disorders
MedDRA (20.1)
Systematic Assessment
EG00013 affected198 at risk
EG0017 affected204 at risk
EG00221 affected568 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG00013 affected198 at risk
EG00112 affected204 at risk
EG00227 affected568 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (20.1)
Systematic Assessment
EG00011 affected198 at risk
EG0017 affected204 at risk
EG00212 affected568 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG00051 affected198 at risk
EG00111 affected204 at risk
EG002146 affected568 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG00048 affected198 at risk
EG0015 affected204 at risk
EG002129 affected568 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG0008 affected198 at risk
EG0015 affected204 at risk
EG00232 affected568 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (20.1)
Systematic Assessment
EG00014 affected198 at risk
EG00114 affected204 at risk
EG00229 affected568 at risk
EG003
Platelet count decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG00010 affected198 at risk
EG0011 affected204 at risk
EG00232 affected568 at risk
EG003
Weight decreased
Investigations
MedDRA (20.1)
Systematic Assessment
EG00010 affected198 at risk
EG0012 affected204 at risk
EG00233 affected568 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (20.1)
Systematic Assessment
EG00042 affected198 at risk
EG00111 affected204 at risk
EG002112 affected568 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00018 affected198 at risk
EG00113 affected204 at risk
EG00247 affected568 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00029 affected198 at risk
EG00115 affected204 at risk
EG00253 affected568 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00013 affected198 at risk
EG00110 affected204 at risk
EG00226 affected568 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00016 affected198 at risk
EG0018 affected204 at risk
EG00239 affected568 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00022 affected198 at risk
EG00112 affected204 at risk
EG00242 affected568 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG00026 affected198 at risk
EG00117 affected204 at risk
EG00250 affected568 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG00043 affected198 at risk
EG0015 affected204 at risk
EG002171 affected568 at risk
EG003
Headache
Nervous system disorders
MedDRA (20.1)
Systematic Assessment
EG00058 affected198 at risk
EG00135 affected204 at risk
EG002139 affected568 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (20.1)
Systematic Assessment
EG00010 affected198 at risk
EG0018 affected204 at risk
EG00229 affected568 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (20.1)
Systematic Assessment
EG00014 affected198 at risk
EG0015 affected204 at risk
EG00224 affected568 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG00015 affected198 at risk
EG00112 affected204 at risk
EG00251 affected568 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG00014 affected198 at risk
EG0012 affected204 at risk
EG00255 affected568 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG00017 affected198 at risk
EG00110 affected204 at risk
EG00235 affected568 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (20.1)
Systematic Assessment
EG00016 affected198 at risk
EG0015 affected204 at risk
EG00247 affected568 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00026 affected198 at risk
EG0016 affected204 at risk
EG00264 affected568 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00014 affected198 at risk
EG0019 affected204 at risk
EG00238 affected568 at risk
EG003
Hair colour changes
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00090 affected198 at risk
EG0019 affected204 at risk
EG002232 affected568 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00042 affected198 at risk
EG0018 affected204 at risk
EG002103 affected568 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00012 affected198 at risk
EG00117 affected204 at risk
EG00225 affected568 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (20.1)
Systematic Assessment
EG00024 affected198 at risk
EG00114 affected204 at risk
EG00263 affected568 at risk
EG003
Hypertension
Vascular disorders
MedDRA (20.1)
Systematic Assessment
EG000108 affected198 at risk
EG00130 affected204 at risk
EG002294 affected568 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
novartis.email@novartis.com
ID
Term
D002292
Carcinoma, Renal Cell
D009369
Neoplasms
Ancestor Terms
ID
Term
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D007680
Kidney Neoplasms
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C516667
pazopanib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
406
BG0041130
=>65 to <75
Title
Measurements
BG00036
BG00155
BG002122
BG003131
BG004344
=>75 to <85
Title
Measurements
BG0008
BG00110
BG00219
BG00327
BG00464
173
BG003164
BG004447
Male
BG000139
BG001154
BG002398
BG003400
BG0041091
471
BG003481
BG0041298
Asian
Title
Measurements
BG00028
BG00126
BG00271
BG00370
BG004195
African American/African Heritage
Title
Measurements
BG0001
BG0010
BG0027
BG0031
BG0049
Other
Title
Measurements
BG0000
BG0011
BG0024
BG0032
BG0047
Missing
Title
Measurements
BG0001
BG0010
BG00218
BG00310
BG00429
571
OG001564
Title
Denominators
Categories
Title
Measurements
OG00089.5(NA to NA)NA = the last follow-up patient in this group died at the end of study, so the median survival was estimated (the survival curve crossed 50%). But the 95% CI was not estimable due to less than 50% events (death) occurring in pazopanib group.
OG001NA(NA to NA)NA = the last follow-up patient in this group was censored at the end of study and less than 50% events (death) occurred, so both median and 95%CI were not estimable
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Log-Rank
0.9880
Adjusted Hazard Ratio
0.998
2-Sided
95
0.759
1.311
Superiority
571
OG001564
Title
Denominators
Categories
DFS at 1 year
ParticipantsOG000423
ParticipantsOG001394
Title
Measurements
OG0000.85(0.81 to 0.88)
OG0010.76(0.72 to 0.79)
DFS at 2 years
ParticipantsOG000308
ParticipantsOG001300
Title
Measurements
OG0000.72(0.67 to 0.75)
OG001
DFS at 3 years
ParticipantsOG000118
ParticipantsOG001118
Title
Measurements
OG0000.65(0.61 to 0.70)
OG001
DFS at 4 years
ParticipantsOG0000
ParticipantsOG0010
769
OG001769
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = DFS median or confidence interval were not determined because not enough events occurred at the analysis.
OG001NA(48.1 to NA)NA = DFS median or upper limit of confidence interval were not determined because not enough events occurred at the analysis.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Log-Rank
0.0126
Adjusted Hazard Ratio
0.802
2-Sided
95
0.675
0.954
Superiority
769
OG001769
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = OS median or confidence interval were not determined because not enough events occurred at the analysis.
OG001NA(NA to NA)NA = OS median or confidence interval were not determined because not enough events occurred at the analysis.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Log-Rank
0.9959
Adjusted Hazard Ratio
1.001
2-Sided
95
0.796
1.257
Superiority
769
OG001769
Title
Denominators
Categories
DFS at 1 year
ParticipantsOG000579
ParticipantsOG001538
Title
Measurements
OG0000.85(0.82 to 0.87)
OG0010.75(0.72 to 0.78)
DFS at 2 years
ParticipantsOG000436
ParticipantsOG001419
Title
Measurements
OG0000.72(0.68 to 0.75)
OG001
DFS at 3 years
ParticipantsOG000231
ParticipantsOG001215
Title
Measurements
OG0000.65(0.62 to 0.69)
OG001
DFS at 4 years
ParticipantsOG00048
ParticipantsOG00146
Title
Measurements
OG0000.62(0.58 to 0.66)
OG001
198
OG001205
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = DFS median or confidence interval were not determined because not enough events occurred at the analysis.
OG00148.1(30.1 to NA)NA = DFS median or upper limit confidence interval were not determined because not enough events occurred at the analysis.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Log-Rank
0.0201
Adjusted Hazard Ratio
0.693
2-Sided
95
0.510
0.943
Superiority
198
OG001205
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA = OS was not determined because not enough events occurred at the analysis.
OG001NA(NA to NA)NA = OS was not determined because not enough events occurred at the analysis.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Stratified Log-Rank
0.9865
Adjusted Hazard Ratio
1.004
2-Sided
95
0.662
1.521
Superiority
Units
Counts
Participants
OG000571
OG001564
Title
Denominators
Categories
Week 52
ParticipantsOG000423
ParticipantsOG001401
Title
Measurements
OG000-3.83± 0.452
OG001-0.43± 0.459
24M DFS FU
ParticipantsOG000335
ParticipantsOG001340
Title
Measurements
OG0000.19± 0.419
OG001
36M DFS FU
ParticipantsOG000294
ParticipantsOG001290
Title
Measurements
OG000-0.14± 0.454
OG001
48M DFS FU
ParticipantsOG000144
ParticipantsOG001140
Title
Measurements
OG000-0.13± 0.526
OG001
54M DFS FU
ParticipantsOG00060
ParticipantsOG00166
Title
Measurements
OG0000.09± 0.653
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
<.001
Mean Difference (Week 52)
-3.397
2-Sided
95
-4.486
-2.307
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.930
Mean Difference (24M DFS FU)
-0.043
2-Sided
95
-1.003
0.917
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.828
Mean Difference (36M DFS FU)
0.119
2-Sided
95
-0.958
1.196
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.603
Mean Difference (48M DFS FU)
-0.347
2-Sided
95
-1.658
0.964
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.841
Mean Difference (54M DFS FU)
-0.170
2-Sided
95
-1.843
1.503
Superiority
Units
Counts
Participants
OG000571
OG001564
Title
Denominators
Categories
Week 52
ParticipantsOG000427
ParticipantsOG001406
Title
Measurements
OG000-2.06± 0.278
OG001-0.44± 0.282
24M DFS FU
ParticipantsOG000340
ParticipantsOG001341
Title
Measurements
OG000-0.32± 0.273
OG001
36M DFS FU
ParticipantsOG000300
ParticipantsOG001293
Title
Measurements
OG000-0.61± 0.291
OG001
48M DFS FU
ParticipantsOG000147
ParticipantsOG001141
Title
Measurements
OG000-0.67± 0.332
OG001
54M DFS FU
ParticipantsOG00061
ParticipantsOG00166
Title
Measurements
OG000-0.21± 0.449
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
<.001
Mean Difference (Week 52)
-1.619
2-Sided
95
-2.283
-0.955
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.726
Mean Difference (24 M DFS FU)
-0.114
2-Sided
95
-0.750
0.522
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.801
Mean Difference (36 M DFS FU)
-0.090
2-Sided
95
-0.789
0.609
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.617
Meat Difference (48 M DFS FU)
-0.212
2-Sided
95
-1.044
0.320
Superiority
OG000
OG001
adjusted for baseline score using mixedm
0.565
Mean Difference (54 M DFS FU)
0.341
2-Sided
95
-0.828
1.510
Superiority
Units
Counts
Participants
OG000571
OG001564
Title
Denominators
Categories
Week 52
ParticipantsOG000425
ParticipantsOG001402
Title
Measurements
OG0000.01± 0.054
OG0010.09± 0.055
24M DFS FU
ParticipantsOG000338
ParticipantsOG001340
Title
Measurements
OG0000.11± 0.056
OG001
36M DFS FU
ParticipantsOG000296
ParticipantsOG001291
Title
Measurements
OG0000.13± 0.059
OG001
48M DFS FU
ParticipantsOG000146
ParticipantsOG001141
Title
Measurements
OG0000.08± 0.075
OG001
54M DFS FU
ParticipantsOG00060
ParticipantsOG00166
Title
Measurements
OG0000.04± 0.090
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.238
Mean Difference (Week 52)
-0.077
2-Sided
95
-0.205
0.051
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.442
Mean Difference (24M DFS FU)
-0.052
2-Sided
95
-0.185
0.081
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.819
Mean Difference (36M DFS FU)
0.016
2-Sided
95
-0.125
0.158
Superiority
OG000
OG001
analysis of covariance
analysis of covariance adjusted for baseline score using mixed-model
0.223
Mean Difference (48M DFS FU)
-0.119
2-Sided
95
-0.311
0.073
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.085
Mean Difference (54M DFS FU)
-0.203
2-Sided
95
-0.435
0.028
Superiority
Units
Counts
Participants
OG000571
OG001564
Title
Denominators
Categories
Week 52
ParticipantsOG000426
ParticipantsOG001404
Title
Measurements
OG000-1.73± 0.101
OG001-0.34± 0.103
24M DFS FU
ParticipantsOG000338
ParticipantsOG001341
Title
Measurements
OG0000.12± 0.061
OG001
36M DFS FU
ParticipantsOG000299
ParticipantsOG001292
Title
Measurements
OG0000.05± 0.067
OG001
48M DFS FU
ParticipantsOG000146
ParticipantsOG001140
Title
Measurements
OG000-0.04± 0.087
OG001
54M DFS FU
ParticipantsOG00061
ParticipantsOG00166
Title
Measurements
OG0000.07± 0.089
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
<.001
Mean Difference (Week 52)
-1.394
2-Sided
95
-1.660
-1.129
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.083
Mean difference (24M DFS FU)
0.117
2-Sided
95
-0.015
0.249
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.307
Mean Difference (36M DFS FU)
0.081
2-Sided
95
-0.074
0.236
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.796
Mean Difference (48M DFS FU)
-0.029
2-Sided
95
-0.249
0.191
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-models
0.885
Mean Difference (54M DFS FU)
-0.016
2-Sided
95
-0.237
0.205
Superiority
Units
Counts
Participants
OG000571
OG001564
Title
Denominators
Categories
Week 52
ParticipantsOG000426
ParticipantsOG001406
Title
Measurements
OG0000.06± 0.153
OG0010.33± 0.155
24M DFS FU
ParticipantsOG000339
ParticipantsOG001341
Title
Measurements
OG0000.39± 0.168
OG001
36M DFS FU
ParticipantsOG000299
ParticipantsOG001293
Title
Measurements
OG0000.43± 0.177
OG001
48M DFS FU
ParticipantsOG000146
ParticipantsOG001141
Title
Measurements
OG0000.51± 0.219
OG001
54M DFS FU
ParticipantsOG00061
ParticipantsOG00166
Title
Measurements
OG0000.31± 0.308
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.143
Mean Differencec (Week 52)
-0.270
2-Sided
95
-0.633
0.092
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.736
Mean Difference (24M DFS FU)
0.069
2-Sided
95
-0.336
0.475
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.397
Mean Difference (36M DFS FU)
0.188
2-Sided
95
-0.247
0.623
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.781
Mean Difference (48M DFS FU)
0.081
2-Sided
95
-0.488
0.649
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.503
Mean Difference (54M DFS FU)
-0.278
2-Sided
95
-1.094
0.539
Superiority
Units
Counts
Participants
OG000571
OG001564
Title
Denominators
Categories
Week 52 thermo. score
ParticipantsOG000417
ParticipantsOG001399
Title
Measurements
OG0000.713± 0.858
OG0011.430± 0.868
24M DFS FU thermo. score
ParticipantsOG000328
ParticipantsOG001334
Title
Measurements
OG0003.356± 0.882
OG001
36M DFS FU thermo. score
ParticipantsOG000288
ParticipantsOG001287
Title
Measurements
OG0003.640± 0.882
OG001
48M DFS FU thermo. score
ParticipantsOG000144
ParticipantsOG001141
Title
Measurements
OG0003.909± 1.014
OG001
54M DFS FU thermo. score
ParticipantsOG00060
ParticipantsOG00165
Title
Measurements
OG0003.076± 1.607
OG001
Week 52 UI score
ParticipantsOG000419
ParticipantsOG001401
Title
Measurements
OG000-0.019± 0.009
OG001
24M DFS FU UI score
ParticipantsOG000334
ParticipantsOG001337
Title
Measurements
OG000-0.004± 0.010
OG001
36M DFS FU UI score
ParticipantsOG000294
ParticipantsOG001288
Title
Measurements
OG0000.002± 0.011
OG001
48M DFS FU UI score
ParticipantsOG000144
ParticipantsOG001141
Title
Measurements
OG000-0.002± 0.013
OG001
54M DFS FU UI score
ParticipantsOG00061
ParticipantsOG00165
Title
Measurements
OG0000.004± 0.017
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.490
Mean Difference (Week 52 thermo)
-0.717
2-Sided
95
-2.751
1.318
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.788
Mean Difference (24M DFS FU- thermo)
-0.285
2-Sided
95
-2.358
1.788
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.266
Mean Difference (36M DFS FU- thermo)
1.180
2-Sided
95
-0.901
3.262
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.570
Mean Difference (48M DFS FU - thermo)
0.725
2-Sided
95
-1.779
3.229
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.346
Mean Difference (54M DFS FU - thermo)
2.023
2-Sided
95
-2.205
6.251
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.111
Mean Difference (Week 52 - UI)
-0.018
2-Sided
95
-0.040
0.004
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.094
Mean Difference (24M DFS FU - UI)
-0.020
2-Sided
95
-0.044
0.003
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.490
Mean Difference (36M DFS FU - UI)
0.010
2-Sided
95
-0.018
0.037
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.580
Mean Difference (48M DFS FU - UI)
-0.009
2-Sided
95
-0.043
0.024
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.473
Mean Difference (54M DFS FU - UI)
0.017
2-Sided
95
-0.029
0.063
Superiority
Units
Counts
Participants
OG000769
OG001769
Title
Denominators
Categories
Week 52
ParticipantsOG000575
ParticipantsOG001554
Title
Measurements
OG000-4.01± 0.385
OG001-0.47± 0.388
24M DFS FU
ParticipantsOG000462
ParticipantsOG001458
Title
Measurements
OG0000.23± 0.361
OG001
36M DFS FU
ParticipantsOG000405
ParticipantsOG001392
Title
Measurements
OG0000.16± 0.385
OG001
48M DFS FU
ParticipantsOG000244
ParticipantsOG001232
Title
Measurements
OG0000.47± 0.421
OG001
54M DFS FU
ParticipantsOG000156
ParticipantsOG001153
Title
Measurements
OG0000.27± 0.505
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
<.001
Mean Difference (Week 52)
-3.536
2-Sided
95
-4.466
-2.606
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.812
Mean difference (24M DFS FU)
-0.102
2-Sided
95
-0.942
0.738
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.621
Mean Difference (36M DFS FU)
0.233
2-Sided
95
-0.690
1.155
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.878
Mean Difference (48M DFS FU)
0.082
2-Sided
95
-0.959
1.122
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.533
Mean Difference (54M DFS FU)
0.412
2-Sided
95
-0.887
1.712
Superiority
Units
Counts
Participants
OG000769
OG001769
Title
Denominators
Categories
Week 52
ParticipantsOG000579
ParticipantsOG001559
Title
Measurements
OG000-2.03± 0.235
OG001-0.51± 0.237
24M DFS FU
ParticipantsOG000467
ParticipantsOG001460
Title
Measurements
OG000-0.24± 0.232
OG001
36M DFS FU
ParticipantsOG000412
ParticipantsOG001395
Title
Measurements
OG000-0.41± 0.247
OG001
48M DFS FU
ParticipantsOG000248
ParticipantsOG001233
Title
Measurements
OG000-0.25± 0.270
OG001
54M DFS FU
ParticipantsOG000157
ParticipantsOG001153
Title
Measurements
OG000-0.23± 0.329
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
<.001
Mean Difference (Week 52)
-1.515
2-Sided
95
-2.078
-0.952
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.961
Mean Difference (24M DFS FU)
0.014
2-Sided
95
-0.534
0.561
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.888
Mean Difference (36M DFS FU)
0.043
2-Sided
95
-0.555
0.641
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.858
Mean Difference (48M DFS FU)
-0.061
2-Sided
95
-0.736
0.614
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.300
Mean Difference (54M DFS FU)
0.452
2-Sided
95
-0.404
1.309
Superiority
Units
Counts
Participants
OG000769
OG001769
Title
Denominators
Categories
Week 52
ParticipantsOG000578
ParticipantsOG001555
Title
Measurements
OG0000.04± 0.045
OG0010.14± 0.046
24M DFS FU
ParticipantsOG000465
ParticipantsOG001458
Title
Measurements
OG0000.15± 0.048
OG001
36M DFS FU
ParticipantsOG000407
ParticipantsOG001393
Title
Measurements
OG0000.19± 0.050
OG001
48M DFS FU
ParticipantsOG000246
ParticipantsOG001243
Title
Measurements
OG0000.16± 0.059
OG001
54M DFS FU
ParticipantsOG000156
ParticipantsOG001153
Title
Measurements
OG0000.16± 0.065
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.059
Mean Difference (Week 52)
-0.103
2-Sided
95
-0.211
0.004
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.487
Mean Difference (24M DFS FU)
-0.041
2-Sided
95
-0.155
0.074
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.885
Mean Difference (36M DFS FU)
0.037
2-Sided
95
-0.085
0.160
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.676
Mean Difference (48M DFS FU)
-0.032
2-Sided
95
-0.183
0.119
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.859
Mean Difference (54M DFS FU)
-0.015
2-Sided
95
-0.183
0.153
Superiority
Units
Counts
Participants
OG000769
OG001769
Title
Denominators
Categories
Week 52
ParticipantsOG000578
ParticipantsOG001557
Title
Measurements
OG000-1.86± 0.089
OG001-0.33± 0.090
24M DFS FU
ParticipantsOG000465
ParticipantsOG001460
Title
Measurements
OG0000.12± 0.052
OG001
36M DFS FU
ParticipantsOG000411
ParticipantsOG001394
Title
Measurements
OG0000.11± 0.057
OG001
48M DFS FU
ParticipantsOG000247
ParticipantsOG001232
Title
Measurements
OG0000.05± 0.065
OG001
54M DFS FU
ParticipantsOG000157
ParticipantsOG001153
Title
Measurements
OG0000.09± 0.074
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
<.001
Mean Diffeence (Week 52)
-1.535
2-Sided
95
-1.769
-1.300
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.127
Mean Diffeence (24M DFS FU)
0.089
2-Sided
95
-0.025
0.202
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.069
Mean Diffeence (36M DFS FU)
0.123
2-Sided
95
-0.009
0.255
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.544
Mean Diffeence (48M DFS FU)
0.049
2-Sided
95
-0.110
0.208
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.518
Mean Difference (54M DFS FU)
0.061
2-Sided
95
-0.124
0.246
Superiority
Units
Counts
Participants
OG000769
OG001769
Title
Denominators
Categories
Week 52
ParticipantsOG000579
ParticipantsOG001559
Title
Measurements
OG000-0.08± 0.134
OG0010.30± 0.136
24M DFS FU
ParticipantsOG000467
ParticipantsOG001460
Title
Measurements
OG0000.30± 0.147
OG001
36M DFS FU
ParticipantsOG000411
ParticipantsOG001395
Title
Measurements
OG0000.3± 0.151
OG001
48M DFS FU
ParticipantsOG000247
ParticipantsOG001243
Title
Measurements
OG0000.50± 0.179
OG001
54M DFS FU
ParticipantsOG000157
ParticipantsOG001153
Title
Measurements
OG0000.39± 0.206
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.022
Mean Diffeence (Week 52)
-0.374
2-Sided
95
-0.695
-0.053
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.567
Mean Diffeence (24M DFS FU)
-0.104
2-Sided
95
-0.462
0.253
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.706
Mean Difference (36M DFS FU)
0.072
2-Sided
95
-0.302
0.446
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.612
Mean Difference (48M DFS FU)
0.120
2-Sided
95
-0.343
0.583
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.870
Mean Difference (54M DFS FU)
-0.045
2-Sided
95
-0.587
0.496
Superiority
Counts
Participants
OG000769
OG001769
Title
Denominators
Categories
Week 52 thermo.
ParticipantsOG000568
ParticipantsOG001546
Title
Measurements
OG0000.744± 0.733
OG0012.859± 0.742
24M DFS FU thermo.
ParticipantsOG000452
ParticipantsOG001450
Title
Measurements
OG0004.043± 0.741
OG001
36M DFS FU thermo.
ParticipantsOG000398
ParticipantsOG001387
Title
Measurements
OG0003.997± 0.774
OG001
48M DFS FU thermo.
ParticipantsOG000245
ParticipantsOG001232
Title
Measurements
OG0004.683± 0.863
OG001
54M DFS FU thermos.
ParticipantsOG000155
ParticipantsOG001149
Title
Measurements
OG0003.650± 1.028
OG001
Week 52 UI score
ParticipantsOG000571
ParticipantsOG001548
Title
Measurements
OG000-0.023± 0.008
OG001
24M DFS FU UI score
ParticipantsOG000460
ParticipantsOG001453
Title
Measurements
OG0000.001± 0.008
OG001
36M DFS FU UI score
ParticipantsOG000404
ParticipantsOG001387
Title
Measurements
OG0000.004± 0.009
OG001
48M DFS FU UI score
ParticipantsOG000244
ParticipantsOG001231
Title
Measurements
OG000-0.004± 0.010
OG001
54M DFS FU UI score
ParticipantsOG000156
ParticipantsOG001147
Title
Measurements
OG000-0.004± 0.012
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.018
Mean Difference (Week 52 - thermo.)
-2.116
2-Sided
95
-3.872
-0.359
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.778
Mean Difference (24M DFS FU - thermo)
-0.253
2-Sided
95
-2.014
1.508
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.376
Mean Difference (36M DFS FU - thermo)
0.847
2-Sided
95
-1.030
2.724
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.905
Mean Difference (48M DFS FU - thermo)
0.131
2-Sided
95
-2.032
2.294
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.768
Mean Difference (54M DFS FU - thermo)
0.401
2-Sided
95
-2.269
3.071
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.007
Mean Difference (Week 52 - UI)
-0.026
2-Sided
95
-0.044
-0.007
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.130
Mean Difference (24M DFS FU - UI)
-0.016
2-Sided
95
-0.036
0.005
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.520
Mean Difference (36M DFS FU - UI)
0.007
2-Sided
95
-0.015
0.030
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.276
Mean Difference (48M DFS FU - UI)
-0.014
2-Sided
95
-0.040
0.011
Superiority
OG000
OG001
analysis of covariance
adjusted for baseline score using mixed-model
0.665
Mean Difference (54M DFS FU - UI)
-0.007
2-Sided
95
-0.037
0.024
Superiority
OG003
Safety Placebo 600 mg
Placebo matching pazopanib 600 mg daily based on safety evaluation. Complete treatment is 12 months.