{"analyses":[{"ciLowerLimit":".832","ciPctValue":"95","ciUpperLimit":"3.205","estimateComment":"The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.","groupDescription":"The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".1559","pValueComment":"The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.","paramType":"Odds Ratio (OR)","paramValue":"1.624","statisticalComment":"The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"43"}]}],"title":"MRD Positive"},{"categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"63"}]}],"title":"MRD Negative"}],"denoms":[{"counts":[{"groupId":"OG000","value":"99"},{"groupId":"OG001","value":"106"}],"units":"Participants"}],"description":"Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\\>=0.1%).","groups":[{"description":"High-dose Cytarabine (HDAC)","id":"OG000","title":"Arm 1: (HDAC)"},{"description":"Low-dose Cytarabine (LDAC)","id":"OG001","title":"Arm 2:(LDAC)"}],"paramType":"NUMBER","populationDescription":"Of the 223 randomized patients, 205 patients were included in the day 22 MRD analysis. 18 patients were not included in the day 22 MRD analysis. 5 patients had inadequate sample for MRD, 11 patients had no suitable phenotype to determine MRD, 1 patient was not done on MRD, and 1 patient was lost for follow-up.","reportingStatus":"POSTED","timeFrame":"Day 22 MRD measurement","title":"Minimal Residual Disease (MRD).","type":"PRIMARY","unitOfMeasure":"participants"}