{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13.8"},{"groupId":"OG001","value":"8.0"}]}],"title":"CTCAE Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36.0"},{"groupId":"OG001","value":"29.2"}]}],"title":"CTCAE Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39.3"},{"groupId":"OG001","value":"38.1"}]}],"title":"CTCAE Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.2"},{"groupId":"OG001","value":"21.2"}]}],"title":"CTCAE Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6.7"},{"groupId":"OG001","value":"2.7"}]}],"title":"CTCAE Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"113"}],"units":"Participants"}],"description":"Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.","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 treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.","reportingStatus":"POSTED","timeFrame":"From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.","title":"Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}