{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-14.85","upperLimit":"-11.62","value":"-13.23"},{"groupId":"OG001","lowerLimit":"-12.83","upperLimit":"-9.55","value":"-11.19"}]}],"title":"Coughing Score (Change from Baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-7.66","upperLimit":"-4.99","value":"-6.33"},{"groupId":"OG001","lowerLimit":"-7.98","upperLimit":"-5.25","value":"-6.61"}]}],"title":"Pain in Chest Score (Change from Baseline)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.70","upperLimit":"-1.49","value":"-3.09"},{"groupId":"OG001","lowerLimit":"-7.30","upperLimit":"-4.04","value":"-5.67"}]}],"title":"Dyspnea Score (Change from Baseline)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"253"},{"groupId":"OG001","value":"251"}],"units":"Participants"}],"description":"EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Questions assess cough, hemoptysis, dyspnea, site specific pain, sore mouth, dysphagia, peripheral neuropathy, and alopecia and pain medication. While the QLQ-LC13 includes more scales, only the Coughing, Pain in chest, and Dyspnea subscale scores were analyzed for this endpoint.\n\nNegative change from baseline scores indicates less symptom severity, and thus improvement on health status.\n\nThe score values calculated by averaging across patients overall mean across all visits. The analysis was performed using a MMRM analysis on the change from baseline in the score at each visit, including subject (as a random effect), treatment, visit (as fixed effect and repeated measure) and treatment by visit interaction as explanatory variables, with the baseline score as a covariate along with the baseline score by assessment interaction.","dispersionType":"95% Confidence Interval","groups":[{"description":"Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W","id":"OG000","title":"Randomized: AZD9291 + Chemo"},{"description":"Osimertinib (AZD9291) 80mg QD.","id":"OG001","title":"Randomized: AZD9291"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Full Analysis Set, includes all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to approximately 33 months after the first patient is randomized.","title":"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC13) (Randomized Component)","type":"SECONDARY","unitOfMeasure":"Scores on a Scale"}