{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0062","pValueComment":"Two-sided p-value from log-rank test stratified by EGFR mutation group and race.","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.401","ciPctValue":"95","ciUpperLimit":"0.866","estimateComment":"Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\\<1 then favours Afatinib 40 mg.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2133","paramType":"Hazard Ratio (HR)","paramValue":"0.589","statisticalComment":"Cox PH regression stratified by EGFR mutation group and race.","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"comment":"As only 82 patients (35.7 percent) in the Afatinib 40 mg deteriorated, the upper limit of Confidence Interval (CI) was not estimable.","groupId":"OG000","lowerLimit":"19.22","upperLimit":"NA","value":"26.97"},{"comment":"As only 44 patients (38.3 percent) in the Pemetrexed/Cisplatin Chemotherapy deteriorated, the upper limit of the CI was not estimable.","groupId":"OG001","lowerLimit":"4.44","upperLimit":"NA","value":"8.02"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"115"}],"units":"Participants"}],"description":"HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.","id":"OG000","title":"Afatinib 40 mg"},{"description":"Patients received Pemetrexed 500 mg/m\\^2 lyophilised powder as intravenous infusion after Cisplatin 75 mg/m\\^2 solution for infusion as intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles.","id":"OG001","title":"Pemetrexed/Cisplatin Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"RS.","reportingStatus":"POSTED","timeFrame":"Throughout the trial until progression (every 3 weeks).","title":"Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing","type":"SECONDARY","unitOfMeasure":"Months."}