{"analyses":[{"ciLowerLimit":"0.17","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.51","estimateComment":"The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).","paramType":"Hazard Ratio (HR)","paramValue":"0.293","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.91","upperLimit":"30.78","value":"23.951"},{"groupId":"OG001","lowerLimit":"3.71","upperLimit":"7.52","value":"5.520"},{"comment":"Upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.","groupId":"OG002","lowerLimit":"12.58","upperLimit":"NA","value":"24.542"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"42"}],"units":"Participants"}],"description":"Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).","id":"OG000","title":"Randomized Phase: Brigatinib 90 mg QD/180 QD"},{"description":"Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).","id":"OG001","title":"Randomized Phase: Crizotinib 250 mg BID"},{"description":"Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).","id":"OG002","title":"Crossover Phase: Brigatinib 90 mg QD/180 mg QD"}],"paramType":"MEDIAN","populationDescription":"ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.","reportingStatus":"POSTED","timeFrame":"Baseline up to end of study (Up to 56 months)","title":"Intracranial Progression Free Survival","type":"SECONDARY","unitOfMeasure":"months"}