{"groups":[{"description":"Participants were administered 35 milligrams per square meter per dose (mg/m²/dose) trifluridine/tipiracil (FTD/TPI) orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab (5 milligrams per kilogram \\[mg/kg\\], intravenous \\[IV\\] infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.","id":"FG000","title":"Trifluridine/Tipiracil + Bevacizumab"},{"description":"Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.","id":"FG001","title":"Trifluridine/Tipiracil"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"4"}],"type":"Switched to marketed drug"},{"reasons":[{"groupId":"FG000","numSubjects":"145"},{"groupId":"FG001","numSubjects":"146"}],"type":"Radiological Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"}],"type":"Clinical Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"52"}],"type":"Radiological And Clinical Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"16"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"246"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"246"},{"groupId":"FG001","numSubjects":"246"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Randomization (1:1 ratio): stratified by geographic region (North America, European Union, Rest of the World), time since 1st metastasis diagnosis (less than \\[\\<\\] 18 months, greater than or equal to \\[\\>=\\] 18 months) and rat sarcoma virus status (wild-type, mutant). Primary analysis of overall survival as primary outcome measure was completed with cutoff date of July 19, 2022; no efficacy analysis was conducted after this cutoff and participants were continued to be followed for safety analysis.","recruitmentDetails":"The study was conducted at 99 active sites in 13 countries. A total of 659 participants were screened, of which 492 participants were randomized and treated."}