{"analyses":[{"ciLowerLimit":"1.353","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.891","estimateComment":"Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0005","paramType":"Odds Ratio (OR)","paramValue":"2.254","statisticalComment":"Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"68.2","upperLimit":"82.5","value":"75.8"},{"groupId":"OG001","lowerLimit":"49.4","upperLimit":"65.9","value":"57.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"description":"ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \\<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.","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":"NUMBER","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":"Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}