{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.1","upperLimit":"53.5","value":"34"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"}],"units":"Participants"}],"description":"To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD.\n\nSubjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit.","dispersionType":"95% Confidence Interval","groups":[{"description":"RP2D 225 mg For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.\n\nPhase II: X-396 (ensartinib): Expanded Cohort","id":"OG000","title":"X-396 (Ensartinib) 225 mg"}],"paramType":"NUMBER","populationDescription":"The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment.","reportingStatus":"POSTED","timeFrame":"18 months","title":"Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD","type":"SECONDARY","unitOfMeasure":"participants"}