{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49.2"},{"groupId":"OG001","value":"13.1"}]}],"title":"By Week 6"},{"categories":[{"measurements":[{"groupId":"OG000","value":"59.9"},{"groupId":"OG001","value":"19.7"}]}],"title":"By Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64.0"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 18"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64.9"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","value":"65.7"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 30"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.1"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 36"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.5"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 42"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.5"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 48"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.9"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 60"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.9"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 72"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66.9"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 84"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67.4"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 96"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67.4"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 108"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67.8"},{"groupId":"OG001","value":"23.0"}]}],"title":"By Week 120"}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1.\n\nFor patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response.\n\nOutcome data are the percentage of patients with OR by each scheduled tumour assessment.","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 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 374","title":"Time to Objective Response (OR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}