{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.6","upperLimit":"10.9","value":"6.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.","id":"OG000","title":"All Participants in Besylate Substudy"}],"paramType":"MEDIAN","populationDescription":"All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.","reportingStatus":"POSTED","timeFrame":"Median of 1.87 months of drug exposure","title":"Overall Survival-Besylate Sub-study","type":"SECONDARY","unitOfMeasure":"Months"}