{"groups":[{"description":"Patients randomized on the first day of continuation phase to receive 3500 units/m\\^2 dose of PEG-asparaginase","id":"FG000","title":"PEG 3500 Units/m^2"},{"description":"Patients randomized on the first day of continuation phase to receive 2,500 units/m\\^2 dose of PEG-asparaginase","id":"FG001","title":"PEG 2500 Units/m^2"},{"description":"Patients who came off study prior to randomization","id":"FG002","title":"Not Randomized"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"13"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"}],"type":"Bone Marrow (BM) or Extramedullary Relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Failure to achieve Complete Remission (CR)"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"5"}],"type":"Participant/Family Withdraw"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Second Malignancy"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"18"}],"type":"Transplant"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}],"type":"Unacceptable Toxicity"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"206"},{"groupId":"FG001","numSubjects":"208"},{"groupId":"FG002","numSubjects":"184"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"194"},{"groupId":"FG001","numSubjects":"188"},{"groupId":"FG002","numSubjects":"133"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"51"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Two (2) were later found ineligible and excluded. Of the 598 eligible patients, 414 patients were randomized to the two treatment arms, 184 were not randomized for various reasons:\n\n* Not Eligible for Randomization (n=41)\n\n  * Death (n=5)\n  * Transplant (n=13)\n  * Withdrawal of Consent (n=3)\n  * Down's Syndrome (n=12)\n  * Poor Organ Function (n=8)\n* Parent/Patient Decision (n=70)\n* Attending Physician Decision (n=4)\n* Enrollment after Completion of Randomization (n=69)","recruitmentDetails":"Between October 29, 2007 and March 26, 2017, 600 patients younger than 19 years of age with newly diagnosed Acute Lymphoblastic Leukemia (ALL) were enrolled."}