{"denoms":[{"counts":[{"groupId":"BG000","value":"242"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"364"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"Gemcitabine / Cisplatin Chemotherapy"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"11.2","value":"56.7"},{"groupId":"BG001","spread":"10.1","value":"55.6"},{"groupId":"BG002","spread":"10.9","value":"56.4"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"242"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"364"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"Treated Set","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"155"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"238"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"87"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"126"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"242"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"364"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Race and Ethnicity were not collected from any participant.","title":"Race and Ethnicity Not Collected","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"138"}],"title":"L858R (L858R alone and L858R + Deletion Exon 19)"},{"measurements":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"186"}],"title":"Deletion Exon 19 (alone)"},{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"40"}],"title":"Other"}],"denoms":[{"counts":[{"groupId":"BG000","value":"242"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"364"}],"units":"Participants"}]}],"description":"EGFR mutation group (L858R / Deletion Exon 19 / other) was a stratification factor.","paramType":"COUNT_OF_PARTICIPANTS","title":"Epidermal growth factor receptor (EGFR)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"89"}],"title":"ECOG PS 0 (baseline)"},{"measurements":[{"groupId":"BG000","value":"194"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"275"}],"title":"ECOG PS 1 (baseline)"}],"denoms":[{"counts":[{"groupId":"BG000","value":"242"},{"groupId":"BG001","value":"122"},{"groupId":"BG002","value":"364"}],"units":"Participants"}]}],"description":"ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work; 2=Ambulatory (\\>50 percent of waking hours), capable of all selfcare, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed or chair more then 50 percent of waking hours; 4=Completely disabled, cannot carry on any selfcare, totally confined to bed or chair; 5=Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) performance status (PS)","unitOfMeasure":"Participants"}],"populationDescription":"The randomised set (RS) included all patients randomised to receive treatment, whether treated or not."}