{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270)."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.95","upperLimit":"2.24","value":"1.18"},{"groupId":"OG001","lowerLimit":"0.95","upperLimit":"1.48","value":"1.20"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"EFS was defined as time from initiation of therapy until treatment failure (defined as failure to reach at least a CRi after consolidation or after induction in participants that did not receive consolidation), relapse, or death from any cause. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp, or CR.\n\nData was IPTW adjusted. Medians were estimated using the Kaplan-Meier (KM) method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.","id":"OG000","title":"Phase 2: B-cell (20/56 mg/m^2)"},{"description":"Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.","id":"OG001","title":"Phase 2: T-cell (20/56 mg/m^2)"}],"paramType":"MEDIAN","populationDescription":"Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.","reportingStatus":"POSTED","timeFrame":"Up to approximately 2 years","title":"Phase 2: Event Free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"Months"}