{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"80","upperLimit":"88","value":"84"},{"groupId":"OG001","lowerLimit":"43","upperLimit":"59","value":"51"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"description":"To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)","dispersionType":"95% Confidence Interval","groups":[{"description":"Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles.\n\nSubjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.","id":"OG000","title":"Stratum 1"},{"description":"Subjects that are in remission after any previous relapse or refractory therapy.\n\nSubjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.","id":"OG001","title":"Stratum 2"}],"paramType":"MEAN","populationDescription":"One subject removed from Stratum 1 due to not fitting study criteria upon review","reportingStatus":"POSTED","timeFrame":"2 Years","title":"Number of Participants With Event Free Survival (EFS) During Study.","type":"PRIMARY","unitOfMeasure":"percentage of subjects without an event"}