{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0001","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.303","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.692","groupDescription":"Cox proportional hazard model stratified by EGFR mutation group","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.458"}],"classes":[{"categories":[{"measurements":[{"comment":"As only 84 patients (34.7 percent) in Afatinib 40mg deteriorated, the upper limit of the confidence interval was not estimable.","groupId":"OG000","lowerLimit":"17.45","upperLimit":"NA","value":"31.05"},{"comment":"As only 39 patients (32.0 percent) in Gemcitabine / Cisplatin deteriorated, the upper limit of the confidence interval was not estimable.","groupId":"OG001","lowerLimit":"4.63","upperLimit":"NA","value":"10.28"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1.\n\nTime to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.","id":"OG000","title":"Afatinib 40 Milligram (mg)"},{"description":"Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.","id":"OG001","title":"Gemcitabine / Cisplatin Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"The randomised set.","reportingStatus":"POSTED","timeFrame":"Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.","title":"Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing","type":"SECONDARY","unitOfMeasure":"months"}