{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"10.2","value":"8.3"},{"groupId":"OG001","lowerLimit":"6.5","upperLimit":"9.5","value":"7.8"},{"groupId":"OG002","lowerLimit":"4.4","upperLimit":"7.5","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"321"},{"groupId":"OG002","value":"318"}],"units":"Participants"}],"title":"QLQ-C30 Global Health Status / HRQoL"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.9","upperLimit":"9.4","value":"7.7"},{"groupId":"OG001","lowerLimit":"6.6","upperLimit":"10.0","value":"8.3"},{"groupId":"OG002","lowerLimit":"4.2","upperLimit":"6.5","value":"5.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"325"},{"groupId":"OG002","value":"320"}],"units":"Participants"}],"title":"QLQ-C30 Physical Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.4","upperLimit":"8.3","value":"6.6"},{"groupId":"OG001","lowerLimit":"5.8","upperLimit":"9.3","value":"7.4"},{"groupId":"OG002","lowerLimit":"3.6","upperLimit":"6.2","value":"4.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"314"},{"groupId":"OG001","value":"313"},{"groupId":"OG002","value":"304"}],"units":"Participants"}],"title":"QLQ-C30 Role Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.1","upperLimit":"9.7","value":"7.6"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"9.3","value":"7.4"},{"groupId":"OG002","lowerLimit":"4.6","upperLimit":"7.5","value":"5.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"323"},{"groupId":"OG001","value":"323"},{"groupId":"OG002","value":"318"}],"units":"Participants"}],"title":"QLQ-C30 Cognitive Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.6","upperLimit":"11.3","value":"8.5"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"12.0","value":"9.5"},{"groupId":"OG002","lowerLimit":"5.8","upperLimit":"11.0","value":"7.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"322"},{"groupId":"OG002","value":"315"}],"units":"Participants"}],"title":"QLQ-C30 Emotional Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.6","upperLimit":"9.4","value":"6.4"},{"groupId":"OG001","lowerLimit":"5.0","upperLimit":"9.6","value":"7.1"},{"groupId":"OG002","lowerLimit":"4.6","upperLimit":"7.4","value":"5.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"320"},{"groupId":"OG001","value":"319"},{"groupId":"OG002","value":"314"}],"units":"Participants"}],"title":"QLQ-C30 Social Functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"5.0","value":"3.7"},{"groupId":"OG001","lowerLimit":"2.9","upperLimit":"4.9","value":"3.8"},{"groupId":"OG002","lowerLimit":"2.1","upperLimit":"3.7","value":"2.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"317"},{"groupId":"OG001","value":"318"},{"groupId":"OG002","value":"314"}],"units":"Participants"}],"title":"QLQ-C30 Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.2","upperLimit":"10.9","value":"8.9"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"8.6","value":"6.5"},{"groupId":"OG002","lowerLimit":"4.6","upperLimit":"7.2","value":"5.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"311"},{"groupId":"OG002","value":"298"}],"units":"Participants"}],"title":"QLQ-C30 Pain"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.6","upperLimit":"10.0","value":"7.8"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"6.6","value":"5.6"},{"groupId":"OG002","lowerLimit":"4.2","upperLimit":"7.5","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"322"},{"groupId":"OG001","value":"322"},{"groupId":"OG002","value":"319"}],"units":"Participants"}],"title":"QLQ-C30 Nausea / Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.8","upperLimit":"9.8","value":"7.9"},{"groupId":"OG001","lowerLimit":"5.8","upperLimit":"8.9","value":"6.9"},{"groupId":"OG002","lowerLimit":"5.5","upperLimit":"8.8","value":"6.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"310"},{"groupId":"OG001","value":"310"},{"groupId":"OG002","value":"301"}],"units":"Participants"}],"title":"QLQ-C30 Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"10.4","value":"8.3"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"9.8","value":"7.4"},{"groupId":"OG002","lowerLimit":"4.2","upperLimit":"7.2","value":"5.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"311"},{"groupId":"OG001","value":"304"},{"groupId":"OG002","value":"301"}],"units":"Participants"}],"title":"QLQ-C30 Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.7","upperLimit":"9.4","value":"7.2"},{"groupId":"OG001","lowerLimit":"4.7","upperLimit":"8.8","value":"7.2"},{"groupId":"OG002","lowerLimit":"5.6","upperLimit":"9.6","value":"7.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"308"},{"groupId":"OG001","value":"316"},{"groupId":"OG002","value":"305"}],"units":"Participants"}],"title":"QLQ-C30 Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"12.2","value":"9.2"},{"groupId":"OG001","lowerLimit":"6.5","upperLimit":"10.0","value":"8.7"},{"groupId":"OG002","lowerLimit":"4.8","upperLimit":"7.5","value":"6.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"315"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"306"}],"units":"Participants"}],"title":"QLQ-C30 Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.3","upperLimit":"13.6","value":"11.0"},{"groupId":"OG001","lowerLimit":"8.1","upperLimit":"12.9","value":"9.8"},{"groupId":"OG002","lowerLimit":"9.2","upperLimit":"15.1","value":"10.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"324"},{"groupId":"OG001","value":"324"},{"groupId":"OG002","value":"320"}],"units":"Participants"}],"title":"QLQ-C30 Diarrhea"}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"321"}],"units":"Participants"}],"description":"The EORTC QLQ-Core 30 version 3 (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 was defined as time from randomization until the date of first clinically meaningful deterioration that was 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 (combination) stage:\n\nPatients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 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 (in combination with durvalumab) at Week 16 post-chemotherapy.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"OG000","title":"T + D + SoC"},{"description":"During chemotherapy (combination) stage:\n\nPatients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"OG001","title":"D + SoC"},{"description":"During chemotherapy (combination) stage:\n\nPatients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.","id":"OG002","title":"SoC Alone"}],"paramType":"MEDIAN","populationDescription":"Global cohort: The FAS included all randomized patients. 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 came first). Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).","title":"Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)","type":"SECONDARY","unitOfMeasure":"months"}