{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.778","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"87.7","upperLimit":"95.5","value":"91.6"},{"groupId":"OG001","lowerLimit":"86.6","upperLimit":"94.8","value":"90.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2).\n\nThe randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (\\<0.01%). Past experience indicate that few patients will fall into these unknown categories.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients randomized on the first day of continuation phase to receive 3500 units/m\\^2 dose of PEG-asparaginase","id":"OG000","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":"OG001","title":"PEG 2500 Units/m^2"}],"paramType":"NUMBER","populationDescription":"Per protocol, the comparison was between the two randomization arms.","reportingStatus":"POSTED","timeFrame":"3.5 years after the last enrollment up to 12.5 years","title":"Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}