{"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 PFS compared with gemcitabine / cisplatin chemotherapy.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.203","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.389","groupDescription":"A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.281"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.66","upperLimit":"13.73","value":"11.01"},{"groupId":"OG001","lowerLimit":"4.67","upperLimit":"6.70","value":"5.59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS.\n\nOnly data collected up until the analysis cut-off date (27 December 2013) were considered. Median 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 (RS) included all patients randomised to receive treatment, whether treated or not.","reportingStatus":"POSTED","timeFrame":"Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"months"}