{"analyses":[{"ciLowerLimit":"0.88","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.29","groupDescription":"Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.522","pValueComment":"Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.","paramType":"Hazard Ratio (HR)","paramValue":"1.06","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.74","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.12","groupDescription":"Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.380","pValueComment":"Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.","paramType":"Hazard Ratio (HR)","paramValue":"0.91","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","groupDescription":"Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.048","pValueComment":"Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.","paramType":"Hazard Ratio (HR)","paramValue":"0.75","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.19","groupDescription":"Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.626","pValueComment":"Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.","paramType":"Hazard Ratio (HR)","paramValue":"0.94","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"3.7","value":"2.8"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"4.1","value":"3.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"467"},{"groupId":"OG001","value":"230"}],"units":"Participants"}],"title":"Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.5","upperLimit":"7.3","value":"5.6"},{"groupId":"OG001","lowerLimit":"3.7","upperLimit":"6.0","value":"5.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"216"}],"units":"Participants"}],"title":"Cough"},{"categories":[{"measurements":[{"comment":"The median and 95% CIs could not be calculated as they were not reached.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Upper limit of 95% CI could not be calculated as it was not reached.","groupId":"OG001","lowerLimit":"21.2","upperLimit":"NA","value":"29.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"472"},{"groupId":"OG001","value":"232"}],"units":"Participants"}],"title":"Hemoptysis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.4","upperLimit":"18.6","value":"11.1"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"13.8","value":"8.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"463"},{"groupId":"OG001","value":"229"}],"units":"Participants"}],"title":"Chest pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"237"}],"units":"Participants"}],"description":"The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.","id":"OG000","title":"Durvalumab (MEDI4736)"},{"description":"Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≤ 90 were included in the analysis.","reportingStatus":"POSTED","timeFrame":"At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.","title":"Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)","type":"SECONDARY","unitOfMeasure":"Months"}