{"groups":[{"description":"Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.","id":"FG000","title":"Dacomitinib"},{"description":"Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.","id":"FG001","title":"Gefitinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"152"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"14"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Did not meet eligibility criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"49"}],"type":"Other reasons and patients who completed the 48-month follow-up period"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Study terminated by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease progression"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"225"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"224"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"225"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The study completed enrollment on 25 Mar 2015 with 452 participants randomized, 227 participants to the dacomitinib arm and 225 participants to the gefitinib arm. After the last data cutoff (DCO) date of 13 May 2019, 11 participants remained in the study to continue dacomitinib treatment. All 11 participants were discontinued from the study by last participant last visit (LPLV) on 27 Jan 2022."}