{"analyses":[{"ciLowerLimit":"0.693","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.956","groupDescription":"A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0103","pValueComment":"P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.","paramType":"Hazard Ratio (HR)","paramValue":"0.814","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.00","upperLimit":"2.86","value":"2.63"},{"groupId":"OG001","lowerLimit":"1.87","upperLimit":"2.10","value":"1.94"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"398"},{"groupId":"OG001","value":"397"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve (\"respond\"), stay the same (\"stabilize\") or worsen (\"progress\") during treatment. 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.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.","reportingStatus":"POSTED","timeFrame":"First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).","title":"Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1","type":"PRIMARY","unitOfMeasure":"Months"}