{"analyses":[{"ciLowerLimit":"0.66","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.93","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0024","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"1-sided stratified log rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.4","upperLimit":"10.7","value":"8.2"},{"groupId":"OG001","lowerLimit":"1.9","upperLimit":"5.9","value":"3.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"360"},{"groupId":"OG001","value":"357"}],"units":"Participants"}],"description":"Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.\n\nDue to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and midostaurin 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and midostaurin at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of midostaurin 50 mg orally twice daily.","id":"OG000","title":"Induction and Consolidation Chemotherapy Plus Midostaurin"},{"description":"Patients will receive daunorubicin 60 mg/m\\^2 by IV push days 1-3 plus cytarabine 200 mg/m\\^2 IV days 1-7, and placebo 50 mg orally twice daily days 8-21. Participants achieving remission will receive four 28 day cycles of high dose cytarabine (3000 mg/m\\^2) days 1, 3, \\& 5 and placebo at 50 mg orally twice daily days 8-14. Maintenance therapy was given to participants who continued in remission for 12 28-day cycles of placebo 50 mg orally twice daily.","id":"OG001","title":"Induction and Consolidation Chemotherapy Plus Placebo"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Duration of study (Up to 10 years)","title":"Event- Free Survival","type":"SECONDARY","unitOfMeasure":"months"}