{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"54"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"33"}]}],"title":"TEAEs Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"15"}]}],"title":"Serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Fatal TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"TEAEs Leading to Discontinuation of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"}]}],"title":"TEAEs Leading to Interruption of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"45"}]}],"title":"TRAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"9"}]}],"title":"TRAEs Grade ≥ 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"9"}]}],"title":"Serious TRAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Fatal TRAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"TRAEs Leading to Discontinuation of IP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"}]}],"title":"TRAEs Leading to Interruption of IP"}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"description":"Adverse event (AE): any untoward medical occurrence. Serious AE: an AE meeting at least 1 of the following serious criteria: fatal; life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event. Severity was graded according to the Common Terminology Criteria for AEs (CTCAE) version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Investigational product (IP) in the HC3 arm refers to dexamethasone, methotrexate, daunorubicin, erwinase, ifosfamide, asparaginase, and vincristine, and in the blinatumomab arm refers to blinatumomab. Treatment-related refers to the assessment of a relationship between IP and the event.","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":"Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received.","reportingStatus":"POSTED","timeFrame":"From first dose of IP through the last dose of IP (up to Day 29) plus 30 days.","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)","type":"SECONDARY","unitOfMeasure":"participants"}