{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"16.1","value":"0.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"}],"units":"Participants"}],"description":"Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.","dispersionType":"90% Confidence Interval","groups":[{"description":"MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.","id":"OG000","title":"MLN8237"}],"paramType":"NUMBER","populationDescription":"Eligible and Treated Patients","reportingStatus":"POSTED","timeFrame":"Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.","title":"Progression-free Survival (PFS) > 6 Months","type":"PRIMARY","unitOfMeasure":"percentage of participants"}