{"groups":[{"description":"Participants received 35 milligrams per meter square (mg/m\\^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.","id":"FG000","title":"TAS-102+BSC"},{"description":"Participants received 35 mg/m\\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.","id":"FG001","title":"Placebo+BSC"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Randomized, but not Treated"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"3"}],"type":"Ongoing at Date of Cut-Off"},{"reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"11"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"35"}],"type":"Clinical Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"192"},{"groupId":"FG001","numSubjects":"110"}],"type":"Radiological Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"3"}],"type":"Physician's Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Deviation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"337"},{"groupId":"FG001","numSubjects":"170"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"335"},{"groupId":"FG001","numSubjects":"168"}],"comment":"All participants who received at least 1 dose of study treatment.","type":"As-Treated (AT) Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"337"},{"groupId":"FG001","numSubjects":"170"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Overall, 625 participants were screened, of which 118 were screen failures due to inclusion/exclusion criteria not met and 507 were randomized and treated with TAS-102 or placebo along with Best supportive care (BSC) (BSC was given to prevent, control, or relieve complications and side effects with the intention to maximize quality of life (QoL) without a specific antineoplastic regimen).","recruitmentDetails":"The study was conducted at study centers in 17 countries. Participants were involved in the study from 24 February 2016 to 19 December 2019."}