{"analyses":[{"ciLowerLimit":"0.98","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.32","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0551","pValueComment":"Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.","paramType":"Odds Ratio (OR)","paramValue":"2.06","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.","groups":[{"description":"Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.","id":"OG000","title":"Afatinib"},{"description":"Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.","id":"OG001","title":"Erlotinib"}],"paramType":"NUMBER","populationDescription":"RS","reportingStatus":"POSTED","timeFrame":"First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).","title":"Number of Participants With Objective Response According to RECIST 1.1","type":"SECONDARY","unitOfMeasure":"Participants"}