{"analyses":[{"ciNumSides":"ONE_SIDED","ciPctValue":"85","ciUpperLimit":"1.403","estimateComment":"Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio","groupDescription":"A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\\<1.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.672","pValueComment":"A priori significance level threshold of alpha=0.15","paramType":"Hazard Ratio (HR)","paramValue":"1.107","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.98","upperLimit":"49.80","value":"38.89"},{"groupId":"OG001","lowerLimit":"25.98","upperLimit":"45.66","value":"35.82"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"67"}],"units":"Participants"}],"description":"Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B.","dispersionType":"90% Confidence Interval","groups":[{"description":"Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV","id":"OG000","title":"Arm B (IR/HR MLL-R Chemotherapy)"},{"description":"Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \\>= 90 days at diagnosis and High Risk (HR) if age \\< 90 days at diagnosis.\n\nAsparaginase: Given IV, IM, or PO\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV or IT\n\nDaunorubicin Hydrochloride: Given IV\n\nDexamethasone: Given IV or PO\n\nEtoposide: Given IV\n\nFilgrastim: Given IV or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLestaurtinib: Given PO\n\nLeucovorin Calcium: Given IV\n\nMercaptopurine: Given PO\n\nMethotrexate: Given IV, IT, or PO\n\nMethylprednisolone: Given IV\n\nPegaspargase: Given IM\n\nPharmacological Study: Correlative studies\n\nPrednisone: Given PO\n\nTherapeutic Hydrocortisone: Given IT\n\nVincristine Sulfate: Given IV","id":"OG001","title":"Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)"}],"paramType":"NUMBER","populationDescription":"All eligible Arm B and ARM C (Dose Level 2) patients were included in the analysis.","reportingStatus":"POSTED","timeFrame":"From start of post-induction therapy for up to 10 years.","title":"Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2","type":"SECONDARY","unitOfMeasure":"percent probability"}