{"analyses":[{"ciLowerLimit":"3.9","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"29.8","estimateComment":"Treatment difference (CA180372 - AIEOP-BFM 2000)","groupDescription":"Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.032","pValueComment":"Superiority test versus AIEOP-BFM 2000","paramType":"Estimate of Difference","paramValue":"16.86","statisticalMethod":"Chi-squared"},{"ciLowerLimit":"-3.3","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"17.2","estimateComment":"Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%","groupDescription":"Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control","groupIds":["OG000"],"nonInferiorityComment":"non-inferiority margin = 5%. One-sided type I error rate of 0.05","nonInferiorityType":"NON_INFERIORITY","pValue":"0.271","pValueComment":"Superiority test versus EsPhALL","paramType":"Estimate of difference","paramValue":"6.91","statisticalMethod":"Chi-squared"},{"ciLowerLimit":"-22.7","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.2","estimateComment":"Treatment difference (CA180372 - COG AALL0031)","groupIds":["OG000"],"nonInferiorityComment":"Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control","nonInferiorityType":"SUPERIORITY","pValue":"0.157","paramType":"Estimate of difference","paramValue":"-10.75","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"57.7","upperLimit":"73.7","value":"66.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"106"}],"units":"Participants"}],"description":"3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment.\n\nEvents for EFS are defined as ANY first one of the following:\n\n* Lack of complete response in bone marrow\n* Relapse at any site\n* Development of second malignant neoplasm\n* Death from any cause","dispersionType":"90% Confidence Interval","groups":[{"description":"Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.","id":"OG000","title":"Dasatinib Cohort"}],"paramType":"NUMBER","populationDescription":"All treated partcipants","reportingStatus":"POSTED","timeFrame":"From first dose to 3 years following first dose","title":"3-year Event-free Survival (EFS) Rate","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}