{"analyses":[{"ciLowerLimit":"0.35","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.66","estimateComment":"The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.","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 intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).","paramType":"Hazard Ratio (HR)","paramValue":"0.481","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.46","upperLimit":"43.20","value":"24.016"},{"groupId":"OG001","lowerLimit":"9.13","upperLimit":"13.01","value":"11.072"},{"groupId":"OG002","lowerLimit":"10.12","upperLimit":"23.85","value":"16.821"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"65"}],"units":"Participants"}],"description":"PFS as assessed by Blinded Independent Review Committee (BIRC), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, was defined as the time interval from the date of randomization until the date of the first documented PD event. The data was censored for participants without a PFS event.","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.","reportingStatus":"POSTED","timeFrame":"Up to end of study (Up to 56 months)","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}