{ "FullStudy":{ "Rank":217970, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514448", "OrgStudyIdInfo":{ "OrgStudyId":"CRAD001LDE43" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-003416-23", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Novartis", "OrgClass":"INDUSTRY" }, "BriefTitle":"Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib", "OfficialTitle":"An Open Label, Single Arm Trial to Evaluate Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of First Line Therapy With Sunitinib or Pazopanib" }, "StatusModule":{ "StatusVerifiedDate":"July 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 21, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 1, 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 1, 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 31, 2017", "ResultsFirstSubmitQCDate":"July 17, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 19, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"July 17, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 19, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Novartis Pharmaceuticals", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Metastatic Renal Cell Carcinoma (mRCC)" ] }, "KeywordList":{ "Keyword":[ "Kidney cancer", "mRCC", "metastic renal cell carcinoma", "everolimus", "sunitinib", "pazopanib" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"29", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Everolimus", "ArmGroupType":"Experimental", "ArmGroupDescription":"Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Everolimus (RAD001)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Everolimus (RAD001)", "InterventionDescription":"Everolimus was used as commercially available formulated tablets of 10 mg strength", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Everolimus" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "RAD001" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Progression-free Patients by Month 6", "PrimaryOutcomeDescription":"Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.", "PrimaryOutcomeTimeFrame":"Month 6" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6", "SecondaryOutcomeDescription":"Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.", "SecondaryOutcomeTimeFrame":"Month 6" },{ "SecondaryOutcomeMeasure":"Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months", "SecondaryOutcomeDescription":"Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment", "SecondaryOutcomeTimeFrame":"24 months" },{ "SecondaryOutcomeMeasure":"Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months", "SecondaryOutcomeDescription":"Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.", "SecondaryOutcomeTimeFrame":"48 months" },{ "SecondaryOutcomeMeasure":"Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months", "SecondaryOutcomeDescription":"The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated", "SecondaryOutcomeTimeFrame":"48 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.\nProgression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.\nPatients scheduled for treatment with everolimus.\nPatients with at least one measurable lesion at baseline as per RECIST v1.1.\n\nExclusion Criteria:\n\nPatients who have received >1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.\nPatients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).\nPatients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.\nPatients unwilling or unable to comply with the protocol.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Novartis Pharmaceuticals", "OverallOfficialAffiliation":"Novartis Pharmaceuticals", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Novartis Investigative Site", "LocationCity":"Chemnitz", "LocationZip":"09130", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Dresden", "LocationZip":"01307", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Hannover", "LocationZip":"30559", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Hof", "LocationZip":"95028", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Kassel", "LocationZip":"34125", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Langen", "LocationZip":"63225", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Leipzig", "LocationZip":"04357", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Magdeburg", "LocationZip":"39120", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Muenster", "LocationZip":"48149", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Ravensburg", "LocationZip":"88214", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Velbert", "LocationZip":"42551", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Wiesbaden", "LocationZip":"65191", "LocationCountry":"Germany" },{ "LocationFacility":"Novartis Investigative Site", "LocationCity":"Wolfsburg", "LocationZip":"38440", "LocationCountry":"Germany" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Single arm study of everolimus broken down into 2 subgroups for analyses and safety based on failed 1st line therapy (sunitinib or pazopanib) prior to starting study.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"1st Line SUN", "FlowGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"1st Line PAZ", "FlowGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"13" } ] } },{ "FlowMilestoneType":"Full Analysis Set (FAS)", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"13" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"8" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"8" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"New Cancer Therapy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Demographic and other baseline data (including disease characteristics) were summarized descriptively for all patients for the FAS. The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"1st Line SUN", "BaselineGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"1st Line PAZ", "BaselineGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"12" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"13" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"25" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67.6", "BaselineMeasurementSpread":"6.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"71.3", "BaselineMeasurementSpread":"6.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"69.2", "BaselineMeasurementSpread":"6.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"17" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Progression-free Patients by Month 6", "OutcomeMeasureDescription":"Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"1st Line SUN", "OutcomeGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1st Line PAZ", "OutcomeGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"13" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"46.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6", "OutcomeMeasureDescription":"Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"1st Line SUN", "OutcomeGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1st Line PAZ", "OutcomeGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"13" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months", "OutcomeMeasureDescription":"Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"80% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"24 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"1st Line SUN", "OutcomeGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1st Line PAZ", "OutcomeGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"13" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.8", "OutcomeMeasurementLowerLimit":"2.6", "OutcomeMeasurementUpperLimit":"3.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.0", "OutcomeMeasurementLowerLimit":"3.0", "OutcomeMeasurementUpperLimit":"10.3" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months", "OutcomeMeasureDescription":"Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"80% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"48 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"1st Line SUN", "OutcomeGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1st Line PAZ", "OutcomeGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"12" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"13" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.8", "OutcomeMeasurementLowerLimit":"10.0", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"upper CI could not be calculated due to too few events" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.4", "OutcomeMeasurementLowerLimit":"13.6", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"upper CI could not be calculated due to too few events" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months", "OutcomeMeasureDescription":"The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated", "OutcomeMeasurePopulationDescription":"Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"48 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"1st Line SUN", "OutcomeGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"1st Line PAZ", "OutcomeGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"1st Line SUN", "EventGroupDescription":"Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.", "EventGroupSeriousNumAffected":"6", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"15", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG001", "EventGroupTitle":"1st Line PAZ", "EventGroupDescription":"Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.", "EventGroupSeriousNumAffected":"8", "EventGroupSeriousNumAtRisk":"13", "EventGroupOtherNumAffected":"13", "EventGroupOtherNumAtRisk":"13" },{ "EventGroupId":"EG002", "EventGroupTitle":"Everolimus All Patients", "EventGroupDescription":"Everolimus - All Patients that failed 1st line SUN and 1st Line PAZ and was on Everolimus 10mg orally once daily", "EventGroupSeriousNumAffected":"14", "EventGroupSeriousNumAtRisk":"29", "EventGroupOtherNumAffected":"28", "EventGroupOtherNumAtRisk":"29" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"ANAEMIA", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA (18.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"29" } ] } },{ "SeriousEventTerm":"ATRIOVENTRICULAR BLOCK COMPLETE", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA (18.0)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"13" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"29" } ] } },{ "SeriousEventTerm":"PERICARDIAL EFFUSION", "SeriousEventOrganSystem":"Cardiac disorders", 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