{"analyses":[{"ciLowerLimit":"0.414","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.249","estimateComment":"Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.72"}],"classes":[{"categories":[{"measurements":[{"comment":"The values were not estimable because there were insufficient events to estimate the median OS time and 95% confidence interval.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The values were not estimable because there were insufficient events to estimate the median OS time and 95% confidence interval.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death or censoring - start date +1)/30.4375. Participants last known to be alive were censored at date of last contact.","dispersionType":"95% Confidence Interval","groups":[{"description":"Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"OG000","title":"Lorlatinib"},{"description":"Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.","id":"OG001","title":"Crizotinib"}],"paramType":"MEDIAN","populationDescription":"The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization.","reportingStatus":"POSTED","timeFrame":"From time of Study Start up to 33 months","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Months"}