{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.56","value":"-2.7"},{"groupId":"OG001","spread":"22.20","value":"-5.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"279"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"title":"Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.51","value":"-5.9"},{"groupId":"OG001","spread":"25.80","value":"-7.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"title":"Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.26","value":"-4.1"},{"groupId":"OG001","spread":"22.00","value":"-1.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.54","value":"-3.6"},{"groupId":"OG001","spread":"22.32","value":"-1.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.05","value":"-5.9"},{"groupId":"OG001","spread":"18.16","value":"11.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.05","value":"-8.8"},{"groupId":"OG001","spread":"21.10","value":"15.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.96","value":"-9.5"},{"groupId":"OG001","spread":"4.56","value":"20.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Cycle 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.82","value":"-4.3"},{"groupId":"OG001","spread":"11.79","value":"16.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Cycle 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.12","value":"2.4"},{"groupId":"OG001","spread":"16.67","value":"16.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"Cycle 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.57","value":"-14.4"},{"groupId":"OG001","spread":"11.79","value":"25.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Cycle 10"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"37.27","value":"-16.7"},{"groupId":"OG001","spread":"11.79","value":"25.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Cycle 11"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.79","value":"-8.3"},{"groupId":"OG001","value":"33.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 12"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"33.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 13"},{"categories":[{"measurements":[{"groupId":"OG001","value":"33.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 14"},{"categories":[{"measurements":[{"groupId":"OG001","value":"33.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Cycle 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.91","value":"-8.8"},{"groupId":"OG001","spread":"25.34","value":"-9.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"283"},{"groupId":"OG001","value":"128"}],"units":"Participants"}],"title":"Last Collection Cycle"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.45","value":"-16.5"},{"groupId":"OG001","spread":"18.33","value":"-8.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"Safety Follow-Up"}],"denoms":[{"counts":[{"groupId":"OG000","value":"337"},{"groupId":"OG001","value":"170"}],"units":"Participants"}],"description":"EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received 35 mg/m\\^2 of 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 a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.","id":"OG000","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":"OG001","title":"Placebo+BSC"}],"paramType":"MEAN","populationDescription":"Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category.","reportingStatus":"POSTED","timeFrame":"Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)","title":"Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"units on a scale"}