{"analyses":[{"ciLowerLimit":"0.74","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.413","estimateComment":"Hazard ratio = hazard rate for Arm B/hazard rate for Arm A","groupDescription":"To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.893","paramType":"Hazard Ratio (HR)","paramValue":"1.022","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"90.7","upperLimit":"94.3","value":"92.48"},{"groupId":"OG001","lowerLimit":"90.5","upperLimit":"94.2","value":"92.33"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"868"},{"groupId":"OG001","value":"866"}],"units":"Participants"}],"description":"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 2-sided log rank test, alpha = 5%. (Completed effective March 19, 2018)","dispersionType":"95% Confidence Interval","groups":[{"description":"Non-DS HR patients receive post induction age-adjusted intrathecal (IT) methotrexate (MTX)","id":"OG000","title":"Non-DS HR B-ALL Arm A"},{"description":"Non-DS HR patients receive post-Induction age-adjusted intrathecal triple therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose methotrexate (IMHDM) backbone","id":"OG001","title":"Non-DS HR B-ALL Arm B"}],"paramType":"NUMBER","populationDescription":"Non-DS HR B-ALL patients with post induction therapies (includes patients from AALL0932). Inevaluable patients were excluded from analysis.","reportingStatus":"POSTED","timeFrame":"At 5 years","title":"DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone","type":"PRIMARY","unitOfMeasure":"Percentage of patients"}