{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.7"},{"groupId":"OG001","value":"27.3"}]}],"title":"skin reactions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100.0"},{"groupId":"OG001","value":"97.0"}]}],"title":"gastrointestinal (GI)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"99"}],"units":"Participants"}],"description":"Safety of afatinib as indicated by incidence of specified adverse events: skin reactions (a preferred term of the system organ class: Skin and subcutaneous tissue disorders) and gastrointestinal (GI) (a system organ class).","groups":[{"description":"Subjects receiving starting doses 40 mg of Afatinib daily.","id":"OG000","title":"BIBW 40mg"},{"description":"Subjects receiving starting doses 50 mg of Afatinib daily.","id":"OG001","title":"BIBW 50mg"}],"paramType":"NUMBER","populationDescription":"Treated set","reportingStatus":"POSTED","timeFrame":"First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.","title":"Safety of BIBW 2992 as Indicated by Incidence of Specified Adverse Events.","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}