{ "FullStudy":{ "Rank":218055, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513317", "OrgStudyIdInfo":{ "OrgStudyId":"CR100752" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"CNTO328MDS2001", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Janssen Research & Development, LLC" },{ "SecondaryId":"2011-000261-12", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Janssen Research & Development, LLC", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Patients With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome", "OfficialTitle":"A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects With International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome" }, "StatusModule":{ "StatusVerifiedDate":"September 2014", "OverallStatus":"Terminated", "WhyStopped":"The study was stopped after the interim analysis based on lack of sufficient efficacy. There were no safety concerns.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 21, 2011", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"September 24, 2014", "ResultsFirstSubmitQCDate":"September 24, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"September 29, 2014", "ResultsFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"October 4, 2013", "DispFirstSubmitQCDate":"October 4, 2013", "DispFirstPostDateStruct":{ "DispFirstPostDate":"October 28, 2013", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 29, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Janssen Research & Development, LLC", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the efficacy of siltuximab, demonstrated by a reduction in red blood cell (RBC), transfusions to treat the anemia of Myelodysplastic Syndrome (MDS).", "DetailedDescription":"The study treatments will be administered double-blind for 12 weeks, meaning that the patient and study personnel will not know the identity of the treatment. Approximately 75 patients will be randomized (patients are assigned to a treatment by a chance) in a 2:1 ratio to receive siltuximab plus best supportive care (BSC) (Group A) or placebo plus BSC (Group B). BSC includes RBC transfusion, antimicrobials, white blood cell (WBC) growth factors, and platelet transfusions. Patients who complete 12 weeks of treatment may qualify to receive siltuximab as open-label (identity of treatment will be known) treatment. Treatment may continue until death, unacceptable toxicity, withdrawal of consent, or the clinical cutoff (defined as 24 weeks after the last patient is randomized), whichever occurs first. The study will end approximately 36 weeks after the last patient is randomized. Patient safety will be monitored. Siltuximab and matching placebo will be supplied as a sterile, lyophilized formulation for reconstitution and intravenous (IV) infusion. Group A: siltuximab (15 mg/kg) administered as a 1-hour infusion every 4 weeks + BSC, or Group B: placebo administered as a 1-hour infusion every 4 weeks + BSC." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Myelodysplastic Syndrome" ] }, "KeywordList":{ "Keyword":[ "Myelodysplastic Syndrome", "MDS", "Blood and lymphatic diseases", "Siltuximab", "Anemic" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"76", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Siltuximab", "ArmGroupType":"Experimental", "ArmGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Siltuximab", "Drug: Best supportive care (BSC)" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Experimental", "ArmGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + BSC", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo", "Drug: Best supportive care (BSC)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Siltuximab", "InterventionDescription":"15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Siltuximab" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Administered as a 1-hour intravenous infusion every 4 weeks", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } },{ "InterventionType":"Drug", "InterventionName":"Best supportive care (BSC)", "InterventionDescription":"Best supportive care according to local standards and guidelines", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo", "Siltuximab" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)", "PrimaryOutcomeDescription":"Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.", "PrimaryOutcomeTimeFrame":"Up to Week 13" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in the Mean Hemoglobin Concentrations at Week 13", "SecondaryOutcomeTimeFrame":"Baseline and Week 13" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13", "SecondaryOutcomeTimeFrame":"Week 13" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13", "SecondaryOutcomeTimeFrame":"8 weeks" },{ "SecondaryOutcomeMeasure":"Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13", "SecondaryOutcomeTimeFrame":"Baseline and Week 13" },{ "SecondaryOutcomeMeasure":"Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13", "SecondaryOutcomeTimeFrame":"8 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nConfirmed diagnosis of myelodysplastic syndrome (MDS), according to World Heath Organization or the French-American-British Cooperative Group pathologic classification, with an International Prognostic Scoring System score 0, 0.5, or 1.0, indicating Low- or INT-1-risk disease.\nDocumented RBC transfusion of at least 2 units of RBC for the treatment of the anemia of MDS in the 8 weeks preceding the start of the Screening Period.\nAdequate iron stores, demonstrated by either the presence of stainable iron in the bone marrow or a serum ferritin of > 100 ng/mL.\nEastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\nSymptomatic anemia (defined by a score > 0 on the Non-Chemotherapy Anemia Symptom Scale [NCA-SS]).\n\nExclusion Criteria:\n\nHad treatment with drugs or other agents targeting IL-6 or its receptor within 4 weeks of randomization.\nAny condition that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments.\nPatients with Chronic Myelomonocytic Leukemia (CMML).\nCauses other than MDS contributing to anemia, such as Vitamin B12 or folate deficiency, bleeding, hemolysis, hemoglobinopathy, or chronic renal failure.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Janssen Research & Development, LLC Clinical Trial", "OverallOfficialAffiliation":"Janssen Research & Development, LLC", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Tampa", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationCountry":"United States" },{ "LocationCity":"New York", "LocationState":"New York", "LocationCountry":"United States" },{ "LocationCity":"Winston-Salem", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationCity":"Houston", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationCity":"Box Hill", "LocationCountry":"Australia" },{ "LocationCity":"Camperdown", "LocationCountry":"Australia" },{ "LocationCity":"St Leonards", "LocationCountry":"Australia" },{ "LocationCity":"Antwerpen", "LocationCountry":"Belgium" },{ "LocationCity":"Brugge", "LocationCountry":"Belgium" },{ "LocationCity":"Gent", "LocationCountry":"Belgium" },{ "LocationCity":"Yvoir", "LocationCountry":"Belgium" },{ "LocationCity":"Den Haag", "LocationCountry":"Netherlands" },{ "LocationCity":"Dordrecht", "LocationCountry":"Netherlands" },{ "LocationCity":"Krasnodar", "LocationCountry":"Russian Federation" },{ "LocationCity":"Moscow N/A", "LocationCountry":"Russian Federation" },{ "LocationCity":"Nizhny Novgorod", "LocationCountry":"Russian Federation" },{ "LocationCity":"Barcelona", "LocationCountry":"Spain" },{ "LocationCity":"Madrid", "LocationCountry":"Spain" },{ "LocationCity":"Oviedo (Asturias)", "LocationCountry":"Spain" },{ "LocationCity":"Salamanca", "LocationCountry":"Spain" },{ "LocationCity":"Valencia", "LocationCountry":"Spain" },{ "LocationCity":"Stockholm", "LocationCountry":"Sweden" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"All 76 participants were enrolled and randomly assigned in the study.", "FlowRecruitmentDetails":"76 participants were enrolled at 6 sites in Spain, 5 sites in the United States, 4 sites in Belgium, 3 sites each in Australia and the Russian Federation, 2 sites in the Netherlands, and 1 site in Sweden.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Siltuximab", "FlowGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Placebo", "FlowGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"26" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"34" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"24" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"15" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Study terminated by sponsor", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"18" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"18" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Siltuximab", "BaselineGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Placebo", "BaselineGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"50" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"26" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"76" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"70.2", "BaselineMeasurementSpread":"7.7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"72", "BaselineMeasurementSpread":"7.61" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"70.8", "BaselineMeasurementSpread":"7.67" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"44" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Australia", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"Belgium", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } },{ "BaselineClassTitle":"Netherlands", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Russian Federation", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" } ] } } ] } },{ "BaselineClassTitle":"Spain", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"15" } ] } } ] } },{ "BaselineClassTitle":"Sweden", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"34" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)", "OutcomeMeasureDescription":"Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.", "OutcomeMeasurePopulationDescription":"Intent-to-treat population: Included all randomized participants", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of participants", "OutcomeMeasureTimeFrame":"Up to Week 13", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Siltuximab", "OutcomeGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.271", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Difference in proportions", "OutcomeAnalysisParamValue":"0.082", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.03", "OutcomeAnalysisCIUpperLimit":"0.20", "OutcomeAnalysisEstimateComment":"The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in the Mean Hemoglobin Concentrations at Week 13", "OutcomeMeasurePopulationDescription":"Intent-to-treat population: Included all randomized participants with evaluable data at Week 13", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"g/dL", "OutcomeMeasureTimeFrame":"Baseline and Week 13", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Siltuximab", "OutcomeGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"31" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"18" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.07", "OutcomeMeasurementSpread":"1.503" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.13", "OutcomeMeasurementSpread":"1.375" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.872", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Difference in LS means", "OutcomeAnalysisParamValue":"0.07", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.79", "OutcomeAnalysisCIUpperLimit":"0.93", "OutcomeAnalysisEstimateComment":"The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13", "OutcomeMeasurePopulationDescription":"Intent-to-treat population: Included all randomized participants", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Week 13", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Siltuximab", "OutcomeGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.494", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Difference in proportions", "OutcomeAnalysisParamValue":"0.042", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.06", "OutcomeAnalysisCIUpperLimit":"0.15", "OutcomeAnalysisEstimateComment":"The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13", "OutcomeMeasurePopulationDescription":"Intent-to-treat population: Included all randomized participants", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Siltuximab", "OutcomeGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"50" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"26" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.8" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.986", "OutcomeAnalysisStatisticalMethod":"Cochran-Mantel-Haenszel", "OutcomeAnalysisParamType":"Difference in proportions", "OutcomeAnalysisParamValue":"0.002", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.09", "OutcomeAnalysisCIUpperLimit":"0.09", "OutcomeAnalysisEstimateComment":"The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13", "OutcomeMeasurePopulationDescription":"Intent-to-treat population: Included all randomized participants with evaluable data at Week 13", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percentage of Bone Marrow Blast Cells", "OutcomeMeasureTimeFrame":"Baseline and Week 13", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Siltuximab", "OutcomeGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"31" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"15" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.1", "OutcomeMeasurementSpread":"8.22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementSpread":"2.08" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.363", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisParamType":"Difference in LS means", "OutcomeAnalysisParamValue":"1.96", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-2.35", "OutcomeAnalysisCIUpperLimit":"6.27", "OutcomeAnalysisEstimateComment":"The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13", "OutcomeMeasurePopulationDescription":"Intent-to-treat population: Included all randomized participants who completed Week 13 unblinding", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"RBC Transfusions", "OutcomeMeasureTimeFrame":"8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Siltuximab", "OutcomeGroupDescription":"15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"36" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"22" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"25" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.073", "OutcomeAnalysisStatisticalMethod":"ANCOVA", 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