{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688)."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.93","upperLimit":"9.24","value":"5.23"},{"groupId":"OG001","lowerLimit":"3.49","upperLimit":"9.18","value":"4.51"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"OS was defined as time from initiation of therapy until death from any cause.\n\nData was IPTW adjusted. Medians were estimated using the 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: Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}