{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.49","upperLimit":"10.94","value":"8.54"},{"groupId":"OG001","lowerLimit":"4.01","upperLimit":"5.78","value":"4.70"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"description":"EORTC QLQ-C30: 30 item questionnaires composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/QOL subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4-point Likert scales with responses from \"not at all\" to \"very much\" and GHS/QoL, scored on scale of 1 (very poor) to 7 (excellent). All scales are transformed from raw scores to linear scales ranging 0 to 100. Higher score for functional \\& GHS/QoL = higher level of functioning, \\& higher score for symptoms scales = higher symptom burden. Time to definitive \\>=10 points deterioration: time from date of randomization to the first deterioration in QoL score \\>=10 points compared to baseline with no later improvement or death due to any cause. Kaplan-Meier method was used.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were administered 35 mg/m²/dose 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; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.","id":"OG000","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":"OG001","title":"Trifluridine/Tipiracil"}],"paramType":"MEDIAN","populationDescription":"Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Date of randomization to first deterioration in QoL score >=10 points or death due to any cause, which ever occurred first (i.e., up to 20 months)","title":"European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30): Time to Definitive Deterioration of >=10 Points in the Global Health Status Score - Kaplan-Meier Analysis","type":"SECONDARY","unitOfMeasure":"months"}