{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245)."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.2","upperLimit":"55.0","value":"42.6"},{"groupId":"OG001","lowerLimit":"14.1","upperLimit":"40.4","value":"27.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"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.\n\nCRi was defined as:\n\n1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease\n2. ANC and platelet counts not fulfilling criteria for CR with partial hematologic recovery (CRh), CR without platelet recovery (CRp), or CR.\n\nCRp was defined as:\n\na. 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.\n\nCRh was defined as:\n\n1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease\n2. Recovery of peripheral counts:\n\ni. ANC ≥ 500/µL but \\< 1000/µL ii. Platelet count ≥ 50 000/µL but \\< 100 000/µL. Data was IPTW adjusted.","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 [up to Day 50 for infants])","title":"Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}