{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0056","pValueComment":"Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.","statisticalMethod":"Exact Clopper-Pearson CI, 2 sided"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.67","upperLimit":"64.60","value":"52.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"}],"units":"Participants"}],"description":"Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (\\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments \\>=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.","id":"OG000","title":"Alectinib 600 mg (Fed): Phase II"}],"paramType":"NUMBER","populationDescription":"Phase II Response evaluable (RE) population comprised all Phase II participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 up to 194 weeks (assessed at every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter) (1 cycle = 21 days)","title":"Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II","type":"PRIMARY","unitOfMeasure":"percentage of participants"}