{ "FullStudy":{ "Rank":217914, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515189", "OrgStudyIdInfo":{ "OrgStudyId":"CA184-169" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2011-004029-28", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Bristol-Myers Squibb", "OrgClass":"INDUSTRY" }, "BriefTitle":"Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab", "OfficialTitle":"A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma" }, "StatusModule":{ "StatusVerifiedDate":"July 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 17, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 6, 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 17, 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 3, 2017", "ResultsFirstSubmitQCDate":"February 3, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 24, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"July 29, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 31, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bristol-Myers Squibb", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Melanoma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"831", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm 1: Ipilimumab (3 mg/kg)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Ipilimumab" ] } },{ "ArmGroupLabel":"Arm 2: Ipilimumab (10 mg/kg)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Ipilimumab" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Biological", "InterventionName":"Ipilimumab", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1: Ipilimumab (3 mg/kg)", "Arm 2: Ipilimumab (10 mg/kg)" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Yervoy", "BMS-734016" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Overall Survival (OS)", "PrimaryOutcomeDescription":"OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.", "PrimaryOutcomeTimeFrame":"Approximately 48 months (assessed up to February 2016)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Progression Free Survival (PFS) by mWHO Criteria", "SecondaryOutcomeDescription":"PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.", "SecondaryOutcomeTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)" },{ "SecondaryOutcomeMeasure":"Best Overall Response Rate (BORR) by mWHO Criteria", "SecondaryOutcomeDescription":"BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or \"not evaluable\" assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.", "SecondaryOutcomeTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)" },{ "SecondaryOutcomeMeasure":"Disease Control Rate (DCR) by mWHO Criteria", "SecondaryOutcomeDescription":"DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or \"not evaluable\" assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.", "SecondaryOutcomeTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)" },{ "SecondaryOutcomeMeasure":"Duration of Response (DOR) by mWHO Criteria", "SecondaryOutcomeDescription":"Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method.", "SecondaryOutcomeTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)" },{ "SecondaryOutcomeMeasure":"Duration of Stable Disease by mWHO Criteria", "SecondaryOutcomeDescription":"Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.", "SecondaryOutcomeTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)" },{ "SecondaryOutcomeMeasure":"Rate of Overall Survival", "SecondaryOutcomeDescription":"OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.", "SecondaryOutcomeTimeFrame":"Approximately 66 months" },{ "SecondaryOutcomeMeasure":"Overall Survival of Participants With Brain Metastases at Baseline", "SecondaryOutcomeDescription":"OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.", "SecondaryOutcomeTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\nUnresectable Stage III or Stage IV melanoma\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\nBrain metastases with symptoms or requiring treatment\nHistory of autoimmune disease", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bristol-Myers Squibb", "OverallOfficialAffiliation":"Bristol-Myers Squibb", "OverallOfficialRole":"Study Director" } ] }, 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}, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28359784", "ReferenceType":"derived", "ReferenceCitation":"Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbé C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"BMS Clinical Trial Patient Recruiting", "SeeAlsoLinkURL":"http://bms.com/studyconnect/Pages/home.aspx" },{ "SeeAlsoLinkLabel":"Investigator Inquiry Form", "SeeAlsoLinkURL":"http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"831 participants were enrolled; 727 were randomized to a treatment group; 726 received at least one dose of study treatment. Of the 105 participants not treated, 81 no longer met study criteria, 11 withdrew consent, 4 suffered an Adverse Event, 4 died, and 5 were not treated due to investigator decision or other reasons.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Ipilimumab (10 mg/kg)", "FlowGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Ipilimumab (3 mg/kg)", "FlowGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Induction", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Includes 1 subject who was randomized but not treated due to an Adverse Event before treatment", "FlowAchievementNumSubjects":"365" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"362" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"128" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"130" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"237" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"232" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Disease Progression", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"109" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"155" } ] } },{ "FlowDropWithdrawType":"Study drug toxicity", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"86" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"36" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"24" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"17" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"14" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"9" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"9" } ] } },{ "FlowDropWithdrawType":"No longer meets study criteria", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" } ] } } ] } },{ "FlowPeriodTitle":"First Re-Induction Phase", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"32" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"17" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"15" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Disease progression", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"14" } ] } },{ "FlowDropWithdrawType":"Study drug toxicity", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"No longer meets study criteria", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"All randomized participants", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Ipilimumab (10 mg/kg)", "BaselineGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Ipilimumab (3 mg/kg)", "BaselineGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"365" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"362" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"727" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"224" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"208" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"432" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"141" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"154" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"295" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"58.6", "BaselineMeasurementSpread":"14.52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"60.7", "BaselineMeasurementSpread":"13.22" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"59.7", "BaselineMeasurementSpread":"13.92" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"146" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"131" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"277" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"219" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"231" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"450" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Overall Survival (OS)", "OutcomeMeasureDescription":"OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.", "OutcomeMeasurePopulationDescription":"All randomized participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"Approximately 48 months (assessed up to February 2016)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.70", "OutcomeMeasurementLowerLimit":"11.63", "OutcomeMeasurementUpperLimit":"17.84" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"11.53", "OutcomeMeasurementLowerLimit":"9.86", "OutcomeMeasurementUpperLimit":"13.27" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority", "OutcomeAnalysisPValue":"0.0400", "OutcomeAnalysisPValueComment":"Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"0.84", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.70", "OutcomeAnalysisCIUpperLimit":"0.99", "OutcomeAnalysisEstimateComment":"Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Progression Free Survival (PFS) by mWHO Criteria", "OutcomeMeasureDescription":"PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.", "OutcomeMeasurePopulationDescription":"All randomized participants.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.83", "OutcomeMeasurementLowerLimit":"2.79", "OutcomeMeasurementUpperLimit":"2.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.79", "OutcomeMeasurementLowerLimit":"2.76", "OutcomeMeasurementUpperLimit":"2.83" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority", "OutcomeAnalysisPValue":"0.1548", "OutcomeAnalysisPValueComment":"Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).", "OutcomeAnalysisStatisticalMethod":"Log Rank", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"0.89", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.76", "OutcomeAnalysisCIUpperLimit":"1.04", "OutcomeAnalysisEstimateComment":"Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Best Overall Response Rate (BORR) by mWHO Criteria", "OutcomeMeasureDescription":"BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or \"not evaluable\" assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.", "OutcomeMeasurePopulationDescription":"All randomized participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants with BORR", "OutcomeMeasureTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.3", "OutcomeMeasurementLowerLimit":"11.8", "OutcomeMeasurementUpperLimit":"19.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.2", "OutcomeMeasurementLowerLimit":"9.0", "OutcomeMeasurementUpperLimit":"16.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Disease Control Rate (DCR) by mWHO Criteria", "OutcomeMeasureDescription":"DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or \"not evaluable\" assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.", "OutcomeMeasurePopulationDescription":"All randomized participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants with DC", "OutcomeMeasureTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.5", "OutcomeMeasurementLowerLimit":"26.8", "OutcomeMeasurementUpperLimit":"36.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"27.9", "OutcomeMeasurementLowerLimit":"23.3", "OutcomeMeasurementUpperLimit":"32.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Duration of Response (DOR) by mWHO Criteria", "OutcomeMeasureDescription":"Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method.", "OutcomeMeasurePopulationDescription":"All randomized participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.33", "OutcomeMeasurementLowerLimit":"5.98", "OutcomeMeasurementUpperLimit":"23.98" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.90", "OutcomeMeasurementLowerLimit":"10.35", "OutcomeMeasurementUpperLimit":"NA", "OutcomeMeasurementComment":"The upper 95% CI for DOR was not reached." } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Duration of Stable Disease by mWHO Criteria", "OutcomeMeasureDescription":"Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.", "OutcomeMeasurePopulationDescription":"All randomized participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.55", "OutcomeMeasurementLowerLimit":"3.02", "OutcomeMeasurementUpperLimit":"8.02" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.19", "OutcomeMeasurementLowerLimit":"2.73", "OutcomeMeasurementUpperLimit":"5.55" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Rate of Overall Survival", "OutcomeMeasureDescription":"OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.", "OutcomeMeasurePopulationDescription":"All randomized participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Approximately 66 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"365" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"362" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Survival rate at 1 year", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"54.28", "OutcomeMeasurementLowerLimit":"49.01", "OutcomeMeasurementUpperLimit":"59.25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"47.62", "OutcomeMeasurementLowerLimit":"42.35", "OutcomeMeasurementUpperLimit":"52.70" } ] } } ] } },{ "OutcomeClassTitle":"Survival rate at 2 years", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"38.46", "OutcomeMeasurementLowerLimit":"33.44", "OutcomeMeasurementUpperLimit":"43.45" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"30.97", "OutcomeMeasurementLowerLimit":"26.21", "OutcomeMeasurementUpperLimit":"35.84" } ] } } ] } },{ "OutcomeClassTitle":"Survival rate at 3 years", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31.16", "OutcomeMeasurementLowerLimit":"26.44", "OutcomeMeasurementUpperLimit":"35.98" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23.15", "OutcomeMeasurementLowerLimit":"18.88", "OutcomeMeasurementUpperLimit":"27.69" } ] } } ] } },{ "OutcomeClassTitle":"Survival rate at 4 years", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26.63", "OutcomeMeasurementLowerLimit":"22.17", "OutcomeMeasurementUpperLimit":"31.28" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20.25", "OutcomeMeasurementLowerLimit":"16.21", "OutcomeMeasurementUpperLimit":"24.62" } ] } } ] } },{ "OutcomeClassTitle":"Survival rate at 5 years", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24.90", "OutcomeMeasurementLowerLimit":"20.54", "OutcomeMeasurementUpperLimit":"29.48" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"18.78", "OutcomeMeasurementLowerLimit":"14.87", "OutcomeMeasurementUpperLimit":"23.05" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Survival of Participants With Brain Metastases at Baseline", "OutcomeMeasureDescription":"OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.", "OutcomeMeasurePopulationDescription":"All randomized participants with brain metastases at baseline", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"months", "OutcomeMeasureTimeFrame":"From date of randomization until 540 death events occurred (approximately 48 months)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Ipilimumab (10 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Ipilimumab (3 mg/kg)", "OutcomeGroupDescription":"Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"65" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"62" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.00", "OutcomeMeasurementLowerLimit":"3.98", "OutcomeMeasurementUpperLimit":"12.78" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.67", "OutcomeMeasurementLowerLimit":"4.21", "OutcomeMeasurementUpperLimit":"6.97" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority", "OutcomeAnalysisParamType":"Hazard Ratio (HR)", "OutcomeAnalysisParamValue":"0.71", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"0.49", "OutcomeAnalysisCIUpperLimit":"1.04", "OutcomeAnalysisEstimateComment":"Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases." } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"From Day 1 of study treatment until 90 days following last day of study treatment, up to study completion (August 2017)", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"10 MG/KG IPILIMUMAB", "EventGroupSeriousNumAffected":"245", "EventGroupSeriousNumAtRisk":"364", "EventGroupOtherNumAffected":"319", "EventGroupOtherNumAtRisk":"364" },{ "EventGroupId":"EG001", "EventGroupTitle":"3 MG/KG IPILIMUMAB", "EventGroupSeriousNumAffected":"194", "EventGroupSeriousNumAtRisk":"362", "EventGroupOtherNumAffected":"302", "EventGroupOtherNumAtRisk":"362" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 20.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"364" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"362" } ] } },{ "SeriousEventTerm":"Bicytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 20.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"364" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"362" } ] } },{ "SeriousEventTerm":"Disseminated intravascular coagulation", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 20.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"364" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"362" } ] } },{ "SeriousEventTerm":"Febrile neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 20.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"364" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"362" } ] } },{ "SeriousEventTerm":"Pancytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 20.0", 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