{"analyses":[{"ciLowerLimit":"1.03","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.41","estimateComment":"The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.","groupDescription":"The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.035","pValueComment":"The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 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":"1.87","statisticalComment":"The p-value was computed using an exact, risk-group stratified, two-sided test.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"57"}],"title":"MRD Positive"},{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"64"}],"title":"MRD Negative"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"121"}],"units":"Participants"}],"description":"MRD-negative is defined as \\<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \\>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.","groups":[{"description":"Patients received Cytarabine + Daunorubicin + Etoposide as their first course of chemotherapy. Subsequent therapy is risk-adapted.","id":"OG000","title":"Cytarabine+Daunorubicin+Etoposide"},{"description":"Patients received Clofarabine + Cytarabine as their first course of chemotherapy. Subsequent therapy is risk-adapted.","id":"OG001","title":"Clofarabine+Cytarabine"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Of 262 randomized patients, 242 patients were included in day 22 MRD analysis. 20 patients were excluded due to: 16 were not evaluable by flow cytometry, 2 died prior to completing the first course of therapy, 2 were off therapy for unacceptable toxicity prior to completion of one course.","reportingStatus":"POSTED","timeFrame":"Day 22 MRD measurement after one course of therapy","title":"Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry","type":"PRIMARY","unitOfMeasure":"Participants"}