{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.00","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0295","pValueComment":"p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.","paramType":"Least Square Mean Difference","paramValue":"5.79","statisticalComment":"A mixed effect model is used with an unstructured covariance matrix.","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.7563","value":"4.007"},{"groupId":"OG001","spread":"27.4748","value":"-4.088"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"description":"HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement.","dispersionType":"Standard Deviation","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"}],"paramType":"MEAN","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 and Month 36","title":"Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 (Version 3.0)","type":"SECONDARY","unitOfMeasure":"score on a scale"}