{"analyses":[{"ciLowerLimit":"0.822","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.444","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","pValue":"0.7293","paramType":"Hazard Ratio (HR)","paramValue":"1.09","statisticalComment":"Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.","statisticalMethod":"one-sided stratified log-rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"4.7","value":"3.3"},{"groupId":"OG001","lowerLimit":"2.0","upperLimit":"5.5","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"139"}],"units":"Participants"}],"description":"The EORTC QLQ LC13 consists of 13 questions and includes 1 multi-item scale and 9 single items assessing symptoms (dyspnea, cough, haemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication use. The scale scores rang from 0 to 100, with higher scores indicating higher (\"worse\") level of symptoms. TTD in pain in chest, dyspnea, or cough was defined as the time from randomization to the first time the participant's score showed a 10 point or greater increase after baseline in any of the 3 symptoms. TTD in months was calculated as (date of deterioration or censoring - randomization date +1)/30.4375.","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":"Participants in the EORTC QLQ-LC13 PRO analysis population with change from baseline scores within each treatment group and subscale.","reportingStatus":"POSTED","timeFrame":"From Baseline up to 33 months","title":"Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13","type":"SECONDARY","unitOfMeasure":"Months"}