{"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI could not be calculated as they were not reached.","groupId":"OG000","lowerLimit":"6.8","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"5.8","upperLimit":"NA","value":"15.5"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG002","lowerLimit":"6.8","upperLimit":"NA","value":"8.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"54"}],"units":"Participants"}],"title":"QLQ-LC13 Coughing"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"3.4","upperLimit":"NA","value":"6.9"},{"groupId":"OG001","lowerLimit":"5.3","upperLimit":"15.5","value":"8.1"},{"groupId":"OG002","lowerLimit":"2.5","upperLimit":"8.6","value":"4.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-LC13 Dyspnea"},{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI could not be calculated as they were not reached.","groupId":"OG000","lowerLimit":"17.3","upperLimit":"NA","value":"NA"},{"comment":"Median and upper limit of 95% CI could not be calculated as they were not reached.","groupId":"OG001","lowerLimit":"11.2","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG002","lowerLimit":"6.9","upperLimit":"NA","value":"10.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-LC13 Hemoptysis"},{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI could not be calculated as they were not reached.","groupId":"OG000","lowerLimit":"6.9","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"5.6","upperLimit":"NA","value":"15.5"},{"groupId":"OG002","lowerLimit":"6.3","upperLimit":"10.9","value":"8.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-LC13 Pain in Arm or Shoulder"},{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI could not be calculated as they were not reached.","groupId":"OG000","lowerLimit":"6.8","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"6.8","upperLimit":"NA","value":"15.5"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG002","lowerLimit":"6.9","upperLimit":"NA","value":"10.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"57"}],"units":"Participants"}],"title":"QLQ-LC13 Pain in Chest"},{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI could not be calculated as they were not reached.","groupId":"OG000","lowerLimit":"7.0","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"6.2","upperLimit":"NA","value":"9.3"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"10.9","value":"8.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"57"}],"units":"Participants"}],"title":"QLQ-LC13 Pain in Other Parts"}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"62"}],"units":"Participants"}],"description":"The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and side effects from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration (calculated using the Kaplan-Meier technique) was defined as time from randomization until the date of first clinically meaningful deterioration (an increase in score from baseline of ≥10) that is confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.","dispersionType":"95% Confidence Interval","groups":[{"description":"During Chemotherapy:\n\nPatients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nPost-Chemotherapy:\n\nPatients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.","id":"OG000","title":"China Cohort: D + T + EP"},{"description":"During Chemotherapy:\n\nPatients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nPost-Chemotherapy:\n\nPatients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.","id":"OG001","title":"China Cohort: D + EP"},{"description":"For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.","id":"OG002","title":"China Cohort: EP"}],"paramType":"MEDIAN","populationDescription":"The China FAS included all randomized patients in the China cohort. For QLQ-L13 symptom scales/items, only patients with baseline scores ≤90 (and with data available) were included in the analysis.","reportingStatus":"POSTED","timeFrame":"At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever comes first). Assessed until China cohort second analysis DCO (maximum of approximately 29 months).","title":"Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-LC13 in the China Cohort","type":"SECONDARY","unitOfMeasure":"months"}