{"analyses":[{"ciLowerLimit":"1.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.06","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0020","paramType":"Odds Ratio (OR)","paramValue":"1.56","statisticalComment":"Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"157"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. 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 Disease Control According to RECIST 1.1","type":"SECONDARY","unitOfMeasure":"Participants"}