{"analyses":[{"ciLowerLimit":"0.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.70","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.50","statisticalComment":"Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the CI could not be estimated in the alectinib arm at the time of data cutoff date (9 Feb 2017).","groupId":"OG000","lowerLimit":"19.9","upperLimit":"NA","value":"25.7"},{"groupId":"OG001","lowerLimit":"7.7","upperLimit":"14.6","value":"10.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"151"}],"units":"Participants"}],"description":"PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG000","title":"Alectinib"},{"description":"Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG001","title":"Crizotinib"}],"paramType":"MEDIAN","populationDescription":"ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)","title":"PFS Independent Review Committee (IRC)-Assessed","type":"SECONDARY","unitOfMeasure":"months"}