{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80)."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.42","upperLimit":"22.20","value":"7.55"},{"comment":"Upper CI limit not evaluable due to insufficient observations occurring above the median.","groupId":"OG001","lowerLimit":"2.57","upperLimit":"NA","value":"9.01"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"description":"DOR was defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause. CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. 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. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count \\< 100 000/µL. CRh was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 500/µL but \\< 1000/µL ii. Platelet count ≥ 50 000/µL but \\< 100 000/µL.","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. Only participants who achieved CRi or a better remission status were included in the analysis. Data was IPTW adjusted. Medians were estimated using the KM method.","reportingStatus":"POSTED","timeFrame":"Up to approximately 2 years","title":"Phase 2: Duration of Remission (DOR)","type":"SECONDARY","unitOfMeasure":"Months"}