{"groups":[{"description":"Participants received TAS-102 orally with a starting dose of 35 milligram per meter square per dose (mg/m\\^2/dose) twice daily (BID) based on body surface area (BSA) along with best supportive care (BSC). The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.","id":"FG000","title":"TAS-102"},{"description":"Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"367"},{"groupId":"FG001","numSubjects":"211"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant refusal"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"534"},{"groupId":"FG001","numSubjects":"266"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"533"},{"groupId":"FG001","numSubjects":"265"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"162"},{"groupId":"FG001","numSubjects":"51"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"372"},{"groupId":"FG001","numSubjects":"215"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Total 1002 participants provided consent, out of which 800 participants were randomized in 2:1 ratio in TAS-102 and placebo treatment groups respectively.","recruitmentDetails":"This was a multicenter study conducted in 101 study centers in 13 countries including the United States, Japan, Spain, Italy, Germany, Belgium, France, Australia, United Kingdom, Austria, Ireland, Sweden, and Czech Republic."}