{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.335","estimateComment":"Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm","groupDescription":"To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.556","paramType":"Hazard Ratio (HR)","paramValue":"1.019","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"72.4","upperLimit":"81.8","value":"77.11"},{"groupId":"OG001","lowerLimit":"72.8","upperLimit":"80.7","value":"76.75"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"488"}],"units":"Participants"}],"description":"(Completed effective February 15, 2017) DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. Compared using a 1-sided log rank test, alpha of 2.5%.","dispersionType":"95% Confidence Interval","groups":[{"description":"Non-DS VHR patients receive a modified MBFM-IMHDM regimen that contains a second IM (Control Arm)","id":"OG000","title":"Non-DS VHR B-ALL Control Arm"},{"description":"Non-DS VHR patients receive cyclophosphamide + etoposide containing regimen (Experimental Arm 1)","id":"OG001","title":"Non-DS VHR B-ALL Exp Arm1"}],"paramType":"NUMBER","populationDescription":"Non-DS VHR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis.","reportingStatus":"POSTED","timeFrame":"At 4 years","title":"DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)","type":"PRIMARY","unitOfMeasure":"Percentage of patients"}