{"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"6.8","upperLimit":"NA","value":"14.5"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"7.6","upperLimit":"NA","value":"15.1"},{"groupId":"OG002","lowerLimit":"6.5","upperLimit":"10.9","value":"7.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"55"}],"units":"Participants"}],"title":"QLQ-C30 Global Health Status / HRQoL"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"4.9","upperLimit":"NA","value":"7.6"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"2.3","upperLimit":"NA","value":"6.8"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG002","lowerLimit":"5.7","upperLimit":"NA","value":"6.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Cognitive Functioning"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"6.8","upperLimit":"NA","value":"20.4"},{"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":"6.9","upperLimit":"NA","value":"10.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Emotional Functioning"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"6.0","upperLimit":"NA","value":"21.8"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"5.8","upperLimit":"NA","value":"9.3"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"10.9","value":"7.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Physical Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.9","upperLimit":"21.3","value":"6.8"},{"groupId":"OG001","lowerLimit":"4.2","upperLimit":"13.9","value":"6.4"},{"groupId":"OG002","lowerLimit":"4.1","upperLimit":"10.0","value":"6.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"57"}],"units":"Participants"}],"title":"QLQ-C30 Role Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.3","upperLimit":"14.1","value":"6.7"},{"groupId":"OG001","lowerLimit":"3.9","upperLimit":"13.3","value":"5.8"},{"groupId":"OG002","lowerLimit":"3.3","upperLimit":"8.3","value":"6.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}],"units":"Participants"}],"title":"QLQ-C30 Social Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.3","upperLimit":"6.8","value":"3.7"},{"groupId":"OG001","lowerLimit":"2.9","upperLimit":"9.6","value":"5.3"},{"groupId":"OG002","lowerLimit":"2.2","upperLimit":"5.9","value":"3.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Fatigue"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"4.7","upperLimit":"NA","value":"8.4"},{"groupId":"OG001","lowerLimit":"3.9","upperLimit":"15.5","value":"9.3"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"10.9","value":"8.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Nausea / Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.9","upperLimit":"17.3","value":"6.6"},{"groupId":"OG001","lowerLimit":"5.5","upperLimit":"15.1","value":"6.2"},{"groupId":"OG002","lowerLimit":"4.6","upperLimit":"8.6","value":"6.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Pain"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"2.6","upperLimit":"NA","value":"8.4"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"3.3","upperLimit":"NA","value":"5.8"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"10.0","value":"6.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"57"}],"units":"Participants"}],"title":"QLQ-C30 Appetite Loss"},{"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":"12.0"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG002","lowerLimit":"8.6","upperLimit":"NA","value":"10.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Constipation"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"9.8","upperLimit":"NA","value":"17.3"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"13.3","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG002","lowerLimit":"8.2","upperLimit":"NA","value":"10.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Diarrhea"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"6.0","upperLimit":"NA","value":"11.6"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"9.3","upperLimit":"NA","value":"15.5"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"10.9","value":"7.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"56"}],"units":"Participants"}],"title":"QLQ-C30 Dyspnea"},{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG000","lowerLimit":"5.2","upperLimit":"NA","value":"7.3"},{"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":"7.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"58"}],"units":"Participants"}],"title":"QLQ-C30 Insomnia"}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"62"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 v3 was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or 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 (a decrease 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-C30 function scales and global health status/HRQoL, only patients with baseline scores ≥10 (and with data available) were included in the analysis. For QLQ-C30 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 HRQoL and PRO Symptoms, Assessed Using EORTC QLQ in the China Cohort","type":"SECONDARY","unitOfMeasure":"months"}