{"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":"FG000","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":"FG001","title":"Erlotinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}],"type":"Other than listed"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"34"}],"type":"Worsening of underlying cancer disease"},{"reasons":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"52"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"20"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"265"},{"groupId":"FG001","numSubjects":"279"}],"type":"Withdrew due to Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}],"type":"Randomised but bot treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"398"},{"groupId":"FG001","numSubjects":"397"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"392"},{"groupId":"FG001","numSubjects":"395"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"398"},{"groupId":"FG001","numSubjects":"397"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Patients screened to ensure that they met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met. Tumor assessments at screening were completed within 21 days and other screening assessments were completed within 28 days, of randomization.","recruitmentDetails":"Open-Label Phase-III trial to compare the efficacy of afatinib with erlotinib for the second-line treatment of patients with advanced non-small cell lung cancer, who completed at least 4 cycles of platinum-based doublet chemotherapy. Randomization ratio was 1:1. Stratification was based on race."}