{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.3","upperLimit":"13.3","value":"9.7"},{"groupId":"OG001","lowerLimit":"8.7","upperLimit":"13.5","value":"11.0"},{"groupId":"OG002","lowerLimit":"6.8","upperLimit":"12.3","value":"8.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"302"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"295"}],"units":"Participants"}],"title":"QLQ-LC13 Cough"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.5","upperLimit":"31.3","value":"17.8"},{"groupId":"OG001","lowerLimit":"10.3","upperLimit":"21.4","value":"14.0"},{"groupId":"OG002","lowerLimit":"9.3","upperLimit":"19.3","value":"11.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"318"}],"units":"Participants"}],"title":"QLQ-LC13 Hemoptysis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.2","upperLimit":"6.4","value":"5.4"},{"groupId":"OG001","lowerLimit":"3.8","upperLimit":"6.4","value":"5.0"},{"groupId":"OG002","lowerLimit":"2.6","upperLimit":"4.5","value":"3.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"325"},{"groupId":"OG002","value":"316"}],"units":"Participants"}],"title":"QLQ-LC13 Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.7","upperLimit":"13.3","value":"10.0"},{"groupId":"OG001","lowerLimit":"7.8","upperLimit":"11.8","value":"9.5"},{"groupId":"OG002","lowerLimit":"6.8","upperLimit":"11.4","value":"8.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"322"},{"groupId":"OG002","value":"309"}],"units":"Participants"}],"title":"QLQ-LC13 Pain in Chest"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.6","upperLimit":"10.9","value":"8.9"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"10.3","value":"8.9"},{"groupId":"OG002","lowerLimit":"6.2","upperLimit":"12.0","value":"8.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"312"},{"groupId":"OG001","value":"311"},{"groupId":"OG002","value":"310"}],"units":"Participants"}],"title":"QLQ-LC13 Pain in Arm or Shoulder"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.8","upperLimit":"12.1","value":"9.7"},{"groupId":"OG001","lowerLimit":"6.8","upperLimit":"11.2","value":"8.9"},{"groupId":"OG002","lowerLimit":"4.9","upperLimit":"9.3","value":"5.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"312"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"306"}],"units":"Participants"}],"title":"QLQ-LC13 Pain in Other Parts"}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"326"},{"groupId":"OG002","value":"321"}],"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 treatment-related symptoms 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 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-LC13 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 PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)","type":"SECONDARY","unitOfMeasure":"months"}