{"analyses":[{"groupDescription":"Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.0001","statisticalMethod":"Exact Clopper-Pearson CI"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.80","upperLimit":"60.04","value":"51.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"138"}],"units":"Participants"}],"description":"Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments \\>/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to \\<10 mm. PR was defined as \\>/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.","id":"OG000","title":"Alectinib"}],"paramType":"NUMBER","populationDescription":"Analysis was performed on RE population (Investigator) which included all participants with measurable disease at baseline according to the investigator, who had baseline tumor assessment and received at least one dose of alectinib.","reportingStatus":"POSTED","timeFrame":"Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)","title":"Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in RE Population","type":"SECONDARY","unitOfMeasure":"percentage of participants"}