{"description":"Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study. The MedDRA version is 23.1 for Phase 1b, and 27.0 for Phase 2.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":4,"seriousNumAtRisk":5,"title":"Phase 1b: Dose Escalation 1 (20 mg/m^2)"},{"deathsNumAffected":2,"deathsNumAtRisk":6,"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 27 mg/m\\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).","id":"EG001","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":4,"seriousNumAtRisk":6,"title":"Phase 1b: Dose Escalation 1 (20/27 mg/m^2)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 27 mg/m\\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Phase 1b: Dose Escalation 2 (20/27 mg/m^2)"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 36 mg/m\\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"EG003","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":6,"seriousNumAtRisk":7,"title":"Phase 1b: Dose Escalation 2 (20/36 mg/m^2)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 45 mg/m\\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"EG004","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":4,"seriousNumAtRisk":4,"title":"Phase 1b: Dose Escalation 2 (20/45 mg/m^2"},{"deathsNumAffected":3,"deathsNumAtRisk":10,"description":"Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\\^2 for the first dose, followed by the target 56 mg/m\\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).","id":"EG005","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":7,"seriousNumAtRisk":10,"title":"Phase 1b: Dose Escalation 2 (20/56 mg/m^2)"},{"deathsNumAffected":41,"deathsNumAtRisk":62,"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":"EG006","otherNumAffected":61,"otherNumAtRisk":61,"seriousNumAffected":44,"seriousNumAtRisk":61,"title":"Phase 2: B-cell (20/56 mg/m^2)"},{"deathsNumAffected":29,"deathsNumAtRisk":44,"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":"EG007","otherNumAffected":43,"otherNumAtRisk":44,"seriousNumAffected":31,"seriousNumAtRisk":44,"title":"Phase 2: T-cell (20/56 mg/m^2)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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23.1/27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5},{"groupId":"EG001","numAffected":0,"numAtRisk":6},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":7},{"groupId":"EG004","numAffected":0,"numAtRisk":4},{"groupId":"EG005","numAffected":0,"numAtRisk":10},{"groupId":"EG006","numAffected":6,"numAtRisk":61},{"groupId":"EG007","numAffected":4,"numAtRisk":44}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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