{"analyses":[{"ciLowerLimit":"-8.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-1.11","groupDescription":"QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0108","paramType":"Mean Difference (Net)","paramValue":"-4.8149","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-12.06","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-4.72","groupDescription":"QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-8.3926","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.78","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.11","groupDescription":"QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5938","paramType":"Mean Difference (Net)","paramValue":"0.6651","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-11.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-6.06","groupDescription":"QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-9.0080","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-1.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.06","groupDescription":"QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0656","paramType":"Mean Difference (Net)","paramValue":"-0.8828","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-9.22","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-2.88","groupDescription":"QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","paramType":"Mean Difference (Net)","paramValue":"-6.0475","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-11.35","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-4.84","groupDescription":"QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Mean Difference (Net)","paramValue":"-8.0959","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-10.24","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-3.31","groupDescription":"QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","paramType":"Mean Difference (Net)","paramValue":"-6.7717","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"0.11","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.59","groupDescription":"QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0427","paramType":"Mean Difference (Net)","paramValue":"3.3521","statisticalMethod":"Mixed Models Analysis"},{"ciLowerLimit":"-5.00","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.69","groupDescription":"QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1382","paramType":"Mean Difference (Net)","paramValue":"-2.1521","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-6.99","upperLimit":"-1.99","value":"-4.4879"},{"groupId":"OG001","lowerLimit":"-2.40","upperLimit":"3.06","value":"0.3271"}]}],"title":"QLQ-LC13 Alopecia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-18.92","upperLimit":"-14.05","value":"-16.4819"},{"groupId":"OG001","lowerLimit":"-10.83","upperLimit":"-5.35","value":"-8.0893"}]}],"title":"QLQ-LC13 Coughing"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.82","upperLimit":"2.35","value":"0.7618"},{"groupId":"OG001","lowerLimit":"-1.76","upperLimit":"1.95","value":"0.09660"}]}],"title":"QLQ-LC13 Dysphagia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-11.20","upperLimit":"-7.20","value":"-9.2029"},{"groupId":"OG001","lowerLimit":"-2.36","upperLimit":"1.97","value":"-0.1948"}]}],"title":"QLQ-LC13 Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.83","upperLimit":"-2.61","value":"-3.2197"},{"groupId":"OG001","lowerLimit":"-3.05","upperLimit":"-1.62","value":"-2.3369"}]}],"title":"QLQ-LC13 Haemoptysis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-12.26","upperLimit":"-8.08","value":"-10.1693"},{"groupId":"OG001","lowerLimit":"-6.51","upperLimit":"-1.74","value":"-4.1218"}]}],"title":"QLQ-LC13 Pain in Arm or Shoulder"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-10.31","upperLimit":"-5.98","value":"-8.1437"},{"groupId":"OG001","lowerLimit":"-2.48","upperLimit":"2.38","value":"-0.04790"}]}],"title":"QLQ-LC13 Pain in Chest"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-10.28","upperLimit":"-5.87","value":"-8.0757"},{"groupId":"OG001","lowerLimit":"-3.97","upperLimit":"1.36","value":"-1.3040"}]}],"title":"QLQ-LC13 Pain in Other Parts"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.04","upperLimit":"5.31","value":"3.1779"},{"groupId":"OG001","lowerLimit":"-2.60","upperLimit":"2.25","value":"-0.1742"}]}],"title":"QLQ-LC13 Peripheral Neuropathy"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.36","upperLimit":"4.13","value":"2.2472"},{"groupId":"OG001","lowerLimit":"2.27","upperLimit":"6.53","value":"4.3993"}]}],"title":"QLQ-LC13 Sore Mouth"}],"denoms":[{"counts":[{"groupId":"OG000","value":"166"},{"groupId":"OG001","value":"163"}],"units":"Participants"}],"description":"QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess the specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of patients with lung cancer receiving chemotherapy. All multi-item scales and single-item measures range from 0 to 100, where higher score indicates greater degree of symptom severity.","dispersionType":"95% Confidence Interval","groups":[{"description":"Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.","id":"OG000","title":"Crizotinib"},{"description":"Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\\*min/mL, approximately 30 min after end of pemetrexed infusion.","id":"OG001","title":"Chemotherapy"}],"paramType":"MEAN","populationDescription":"The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.","reportingStatus":"POSTED","timeFrame":"Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)","title":"Change From Baseline in Lung Cancer Symptom Scores as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)","type":"SECONDARY","unitOfMeasure":"units on a scale"}