{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"30.8","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \\<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.","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":"NUMBER","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 Response Rate-Besylate Sub-study","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}