{"analyses":[{"ciLowerLimit":"0.44","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.74","groupDescription":"Coughing","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.7042","pValueComment":"Stratified analysis","paramType":"Hazard Ratio (HR)","paramValue":"0.88","statisticalMethod":"Log Rank"},{"ciLowerLimit":"1.05","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.92","groupDescription":"Dyspnea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0285","pValueComment":"Stratified analysis","paramType":"Hazard Ratio (HR)","paramValue":"1.76","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.61","groupDescription":"Pain in arm and shoulder","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2377","pValueComment":"Stratified analysis","paramType":"Hazard Ratio (HR)","paramValue":"1.43","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.24","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.10","groupDescription":"Pain in chest","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0796","pValueComment":"Stratified analysis","paramType":"Hazard Ratio (HR)","paramValue":"0.51","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.68","groupDescription":"Composite score","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6435","pValueComment":"Stratified analysis","paramType":"Hazard Ratio (HR)","paramValue":"1.10","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median deterioration not reached at CCOD","groupId":"OG000","lowerLimit":"24.0","upperLimit":"NA","value":"NA"},{"comment":"Median deterioration not reached at CCOD","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Coughing"},{"categories":[{"measurements":[{"comment":"Upper limit of the CI not reached at CCOD","groupId":"OG000","lowerLimit":"11.8","upperLimit":"NA","value":"22.8"},{"comment":"Median deterioration not reached at CCOD","groupId":"OG001","lowerLimit":"21.0","upperLimit":"NA","value":"NA"}]}],"title":"Dyspnea"},{"categories":[{"measurements":[{"comment":"Median deterioration not reached at CCOD","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median deterioration not reached at CCOD","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Pain in arm and shoulder"},{"categories":[{"measurements":[{"comment":"Median deterioration not reached at CCOD","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median deterioration not reached at CCOD","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Pain in chest"},{"categories":[{"measurements":[{"comment":"Upper limit of the CI not reached at CCOD","groupId":"OG000","lowerLimit":"5.0","upperLimit":"NA","value":"12.7"},{"comment":"Upper limit of the CI not reached at CCOD","groupId":"OG001","lowerLimit":"9.8","upperLimit":"NA","value":"21.0"}]}],"title":"Composite score (c, p in c, d)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"151"}],"units":"Participants"}],"description":"The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \\>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \\>or=10-point increase above baseline followed by death within 5 weeks from the last assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received alectinib at 600 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG000","title":"Alectinib"},{"description":"Participants received crizotinib at 250 mg orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG001","title":"Crizotinib"}],"paramType":"MEDIAN","populationDescription":"ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline, every 4 weeks until disease progression (up to 33 months)","title":"Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)","type":"SECONDARY","unitOfMeasure":"months"}