{"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":"-10.14","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":"-10.32","statisticalMethod":"Unstratified log-rank test"},{"ciLowerLimit":"0.16","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 survival for blinatumomab relative to HC3.)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Stratified HR","paramValue":"0.33"},{"ciLowerLimit":"0.16","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.65","estimateComment":"Cox proportional hazard model. (HR \\< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Unstratified HR","paramValue":"0.32"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper 95% CI was not estimable due to too few events.","groupId":"OG000","lowerLimit":"17.5","upperLimit":"NA","value":"25.6"},{"comment":"Median and 95% CIs were not estimable due to too few events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"OS was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.\n\nMonths were 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":"FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.","reportingStatus":"POSTED","timeFrame":"At final analysis, overall median follow-up time for OS was 55.2 months.","title":"Kaplan Meier Estimate: Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}