{"analyses":[{"ciLowerLimit":"4.522","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.679","groupDescription":"A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"7.572","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"61.5","upperLimit":"73.6","value":"67.8"},{"groupId":"OG001","lowerLimit":"15.8","upperLimit":"31.4","value":"23.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR.\n\nCR is defined as the disappearance of all target lesions and non-target lesions and no new lesions.\n\nPR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions.\n\n(Exact 95% Confidence interval by Clopper and Pearson.)","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":"NUMBER","populationDescription":"The randomised set.","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 374","title":"Objective Response (OR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}