{"analyses":[{"ciLowerLimit":"0.561","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.091","estimateComment":"Hazard ratio = hazard rate for Arm B/hazard rate for Arm A","groupDescription":"To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.074","paramType":"Hazard Ratio (HR)","paramValue":"0.782","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"77.0","upperLimit":"86.4","value":"81.7"},{"groupId":"OG001","lowerLimit":"80.8","upperLimit":"89.4","value":"85.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"416"},{"groupId":"OG001","value":"408"}],"units":"Participants"}],"description":"EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive combination chemotherapy without bortezomib.","id":"OG000","title":"Arm A (Combination Chemotherapy)"},{"description":"Patients received combination therapy with bortezomib (4 doses at 1.3mg/m2 during Induction and 4 doses at 1.3mg/m2 during Delayed Intensification)","id":"OG001","title":"Arm B (Combination Chemotherapy, Bortezomib)"}],"paramType":"NUMBER","populationDescription":"As pre-specified in the protocol, this analysis includes all eligible patients (T-ALL+T-LLy) enrolled on the study. Arms were combined for this analysis as pre-specified in the protocol.","reportingStatus":"POSTED","timeFrame":"3 years","title":"Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}