{"analyses":[{"estimateComment":"A normal score \\< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Stratification factors were: age (1 to 9 years vs other \\[\\< 1 year and \\> 9 years\\]), and marrow/MRD status (M1 with MRD level \\< 10\\^-3 vs M1 with MRD level ≥ 10\\^-3 vs M2).","paramType":"Normal score","paramValue":"-11.54","statisticalMethod":"Stratified log-rank test"},{"estimateComment":"A normal score \\< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.001","paramType":"Normal score","paramValue":"-11.16","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.19","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.66","estimateComment":"Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \\< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Stratified hazard ratio (HR)","paramValue":"0.36"},{"ciLowerLimit":"0.22","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.70","estimateComment":"Cox proportional hazard model. (HR \\< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Unstratified HR","paramValue":"0.39"},{"ciLowerLimit":"0.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.64","estimateComment":"Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \\<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Stratified HR w/time-dependent covariate","paramValue":"0.36"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.5","upperLimit":"12.7","value":"7.4"},{"comment":"NA=not estimable (median EFS and upper confidence interval \\[CI\\] were not reached at time of data cutoff)","groupId":"OG001","lowerLimit":"12.0","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"EFS is calculated from the time of randomization until the date of relapse or M2 marrow (representative bone marrow aspirate or biopsy with ≥ 5% and \\< 25% blasts) after having achieved a complete remission (CR), failure to achieve a CR at the end of treatment, second malignancy, or death due to any cause, whichever occurs first. Participants who failed to achieve a CR following treatment with investigational product (IP) or who died before the disease assessment at the end of treatment were considered treatment failures and assigned an EFS duration of 1 day. Participants still alive and event-free were censored on their last disease assessment date.\n\nParticipants were said to be in CR when they had the following:\n\n* M1 marrow\n* Peripheral blood without blasts\n* Absence of extramedullary leukemic involvement\n\nMonths are calculated as days from randomization date 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":"Full Analysis Set: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received (primary analysis population).","reportingStatus":"POSTED","timeFrame":"As of the primary analysis data cutoff date (17 July 2019), overall median follow-up time for EFS was 22.4 months.","title":"Kaplan Meier Estimate: Event-Free Survival (EFS; Primary Analysis)","type":"PRIMARY","unitOfMeasure":"months"}