{"analyses":[{"ciLowerLimit":"0.31","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.89","estimateComment":"hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.015","paramType":"Hazard Ratio (HR)","paramValue":"0.53","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median RFS not reached The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.","groupId":"OG000","lowerLimit":"37.1","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"30.3","upperLimit":"69.0","value":"35.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"112"},{"groupId":"OG001","value":"112"}],"units":"Participants"}],"description":"RFS was defined as time from randomization to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment.\n\nRelapse/Persistent Disease\n\nPersistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:\n\n* Reappearance or persistence of blasts in the blood\n* Presence of \\> 5% blasts, not attributable to another cause (e.g., bone marrow regeneration).\n* In the case of isolated CNS relapse such as a positive cytospin examination of CSF, please consult with Study Chair. Perform bone marrow biopsy (if not already done) to confirm presence or lack of medullary relapse.","dispersionType":"95% Confidence Interval","groups":[{"description":"MRD negative patients received induction treatment and intensification treatment and then were randomized to receive blinatumomab plus chemotherapy.","id":"OG000","title":"MRD Negative - Blinatumomab + Chemotherapy"},{"description":"MRD negative patients received induction treatment and intensification treatment and then were randomized to receive chemotherapy.","id":"OG001","title":"MRD Negative - Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"All MRD-negative patients randomized to either blinatumomab + chemotherapy or chemotherapy alone were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years","title":"Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy","type":"SECONDARY","unitOfMeasure":"months"}