{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval \\[CI\\]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31)."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.9","upperLimit":"23.7","value":"14.8"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"23.8","value":"13.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"CR was defined as:\n\n1. Attainment of M1 bone marrow status (less than 5% blasts in a bone marrow aspirate and at least 200 cells counted) with no evidence of circulating blasts or extramedullary disease.\n2. Recovery of peripheral counts:\n\n   * Absolute neutrophil count (ANC) greater than or equal to 1000/µL\n   * Platelet count greater than or equal to 100000/µL.\n   * Assessed between days 29 and 45\n\nData was adjusted as inverse probability of treatment weight (IPTW) for the average treatment effect of the treated (IPTW-ATTW).","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":"NUMBER","populationDescription":"Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.","reportingStatus":"POSTED","timeFrame":"Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [Day 36 to Day 50 for infants])","title":"Phase 2: Percentage of Participants With Complete Remission (CR) After Induction Therapy","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}