{"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 OS compared with gemcitabine / cisplatin chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4013","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.715","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.144","groupDescription":"A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.904"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"20.40","upperLimit":"27.33","value":"23.10"},{"groupId":"OG001","lowerLimit":"17.94","upperLimit":"25.56","value":"23.46"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.\n\nMedian time results from unstratified 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":"From randomisation up to 374 weeks","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}