{"analyses":[{"groupDescription":"MRD response by PCR","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Cochran-Mantel-Haenszel test adjusting for the stratification factors: 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).","statisticalMethod":"Cochran-Mantel-Haenszel"},{"groupDescription":"MRD response by flow cytometry","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","pValueComment":"Cochran-Mantel-Haenszel test adjusting for the stratification factors: 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).","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38.3","upperLimit":"67.5","value":"53.1"},{"groupId":"OG001","lowerLimit":"83.1","upperLimit":"98.7","value":"93.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"MRD Response by PCR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"45.9","upperLimit":"73.0","value":"60.0"},{"groupId":"OG001","lowerLimit":"82.1","upperLimit":"97.9","value":"92.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"title":"MRD Response by Flow Cytometry"}],"denoms":[{"counts":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory.\n\nMRD response was defined as MRD level \\< 10\\^-4, by polymerase chain reaction (PCR) or flow cytometry, at the end of treatment (Cycle 1 Day 29) with study drug. Participants who were part of the MRD Evaluable Set and were missing the end of treatment (Cycle 1 Day 29) assessment for a respective MRD assessment method were considered not to have achieved a response.","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":"NUMBER","populationDescription":"MRD Evaluable Set: participants for whom an evaluable baseline MRD marker can be found with either of the MRD assessment methods of PCR or flow cytometry.","reportingStatus":"POSTED","timeFrame":"Up to End of Treatment (Cycle 1, Day 29)","title":"Percentage of Participants With an MRD Response Within 29 Days of Treatment Initiation","type":"SECONDARY","unitOfMeasure":"percentage of participants"}