{"analyses":[{"ciLowerLimit":"0.16","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.52","estimateComment":"The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \\< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.29"},{"ciLowerLimit":"0.15","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.48","estimateComment":"The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \\< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Stratified hazard ratio (HR)","paramValue":"0.27"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.8","upperLimit":"18.6","value":"7.9"},{"comment":"NA=not estimable (median CIR and confidence intervals were not reached at final analysis)","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"CIR estimate, presented as median months to relapse, calculated from date of achievement of first CR, using the cumulative incidence method (Fine JP, Gray RJ:1999). Deaths prior to relapse not considered related to an otherwise undocumented relapse were treated as a competing risk. Participants still alive without a date of relapse were censored at the time of last follow-up.\n\nRelapse=presence of ≥1 of the following:\n\n* isolated bone marrow relapse (M3 marrow \\[representative bone marrow aspirate or biopsy with ≥25% blasts\\] in the absence of extramedullary involvement)\n* combined bone marrow relapse (M2 \\[representative bone marrow aspirate or biopsy with ≥5% and \\<25% blasts\\] or M3 marrow and ≥1 extramedullary manifestation of acute lymphoblastic leukemia)\n* central nervous system extramedullary relapse\n* testicular extramedullary relapse\n* extramedullary relapse at other sites\n\nMonths were calculated as days from randomization to event/censor date, divided by 30.5.","dispersionType":"95% Confidence Interval","groups":[{"description":"One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\\^2 IV for 1 hour on Days 2-4), and pegylated \\[PEG\\]-asparaginase (1000 U/m\\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\\^2 IV or IM every 48 hours for a total of 6 doses).","id":"OG000","title":"HC3 Chemotherapy"},{"description":"One 4-week cycle of blinatumomab 15 μg/m\\^2/day as a continuous intravenous infusion (CIVI).","id":"OG001","title":"Blinatumomab"}],"paramType":"MEDIAN","populationDescription":"FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.","reportingStatus":"POSTED","timeFrame":"At final analysis, the overall maximum follow-up time was 82.0 months.","title":"Cumulative Incidence of Relapse (CIR)","type":"SECONDARY","unitOfMeasure":"months"}