{"analyses":[{"ciLowerLimit":"0.46","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.19","groupDescription":"Fatigue","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2079","paramType":"Hazard Ratio (HR)","paramValue":"0.74","statisticalComment":"Stratified analysis","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.88","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.15","groupDescription":"Dyspnea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1137","pValueComment":"Stratified analysis","paramType":"Hazard Ratio (HR)","paramValue":"1.66","statisticalMethod":"Log Rank"}],"classes":[{"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":"9.4","upperLimit":"NA","value":"NA"}]}],"title":"Fatigue"},{"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":"Dyspnea"}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"151"}],"units":"Participants"}],"description":"The EORTC QLQ-30 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 global health status or function is defined as a \\>or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \\>or=10-point decrease from 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 European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)","type":"SECONDARY","unitOfMeasure":"months"}