{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"78.86","upperLimit":"88.78","value":"83.82"},{"groupId":"OG001","lowerLimit":"84.79","upperLimit":"92.99","value":"88.89"},{"groupId":"OG002","lowerLimit":"83.99","upperLimit":"92.69","value":"88.34"},{"groupId":"OG003","lowerLimit":"86.55","upperLimit":"94.47","value":"90.51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"244"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"245"},{"groupId":"OG003","value":"246"}],"units":"Participants"}],"title":"Standard and Intensified therapy"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"83.63","upperLimit":"91.19","value":"87.41"},{"groupId":"OG001","lowerLimit":"84.76","upperLimit":"91.82","value":"88.29"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"500"},{"groupId":"OG001","value":"509"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"title":"Standard therapy"}],"denoms":[{"counts":[{"groupId":"OG000","value":"500"},{"groupId":"OG001","value":"509"},{"groupId":"OG002","value":"245"},{"groupId":"OG003","value":"246"}],"units":"Participants"}],"description":"EFS for SR-Average with standard and Intensified Consolidation. 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.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and methotrexate. Patients with Down syndrome (DS) receive leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and methotrexate. Patients with DS receive leucovorin calcium), and standard delayed intensification (DI) therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and methotrexate. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"OG000","title":"Group 2-SR-avg ALL, Arm I-combination Chemotherapy"},{"description":"Patients receive standard consolidation therapy (vincristine sulfate, mercaptopurine and MTX. Patients with Down syndrome (DS) receive leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"OG001","title":"Group 2-SR-avg ALL, Arm II-combination Chemotherapy"},{"description":"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), standard interim maintenance therapy (vincristine sulfate, dexamethasone, mercaptopurine and MTX. Patients with DS receive leucovorin calcium), and standard DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine and MTX. Patients with DS receive dexamethasone, leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"OG002","title":"Group 2-SR-avg ALL, Arm III-combination Chemotherapy"},{"description":"Patients receive intensified consolidation therapy (cyclophosphamide, cytarabine, mercaptopurine and vincristine sulfate, pegaspargase, MTX. Patients with DS receive oral leucovorin calcium), augmented interim maintenance therapy (vincristine sulfate, MTX and pegaspargase. Patients with DS receive leucovorin calcium), and augmented DI therapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, cytarabine, thioguanine, MTX. Patients with DS receive dexamethasone and leucovorin calcium), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.\n\ndoxorubicin hydrochloride: Given IV or IT\n\ncytarabine: Given IV or SC\n\ndexamethasone: Given IV or PO\n\npegaspargase: Given IM\n\nmethotrexate: Given IM or IT\n\nleucovorin calcium: Given PO\n\nmercaptopurine: Given PO\n\ncyclophosphamide: Given IV\n\nthioguanine: Given PO\n\nvincristine sulfate: Given IV","id":"OG003","title":"Group 2-SR-avg ALL, Arm IV-combination Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Only eligible patients are included in this population. Populations are based on enrollments for all four arms initially, and then only for Arms I and II (standard therapy) once Arms III and IV (intensified therapy) were closed to accrual.","reportingStatus":"POSTED","timeFrame":"6 years","title":"Event-free Survival (EFS) for SR-Average ALL Patients","type":"PRIMARY","unitOfMeasure":"percent probability"}