{"analyses":[{"ciLowerLimit":"0.101","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.17","groupDescription":"MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Odds Ratio (OR)","paramValue":"0.131","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4378"},{"groupId":"OG001","value":"258"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4609"},{"groupId":"OG001","value":"362"}],"units":"Participants"}],"description":"Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)","groups":[{"description":"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \\< 0.1% OR MRD \\>= 0.1% and \\< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \\>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nvincristine sulfate: Given IV","id":"OG000","title":"All Patients for Induction, MRD Negative"},{"description":"All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \\< 0.1% OR MRD \\>= 0.1% and \\< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \\>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nvincristine sulfate: Given IV","id":"OG001","title":"All Patients for Induction, MRD Positive"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.","reportingStatus":"POSTED","timeFrame":"Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.","title":"Early Marrow Status (EMS) by MRD Status End Induction (Day 29)","type":"SECONDARY","unitOfMeasure":"Participants"}