{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.15","upperLimit":"11.83","value":"8.97"},{"groupId":"OG001","lowerLimit":"3.71","upperLimit":"5.62","value":"4.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"149"}],"units":"Participants"}],"title":"Physical functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.49","upperLimit":"10.94","value":"8.57"},{"groupId":"OG001","lowerLimit":"3.78","upperLimit":"5.06","value":"4.40"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"147"}],"units":"Participants"}],"title":"Role functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.51","upperLimit":"12.12","value":"9.95"},{"groupId":"OG001","lowerLimit":"4.70","upperLimit":"6.60","value":"5.85"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"128"}],"units":"Participants"}],"title":"Emotional functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.34","upperLimit":"12.25","value":"9.36"},{"groupId":"OG001","lowerLimit":"4.07","upperLimit":"6.11","value":"4.73"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"132"}],"units":"Participants"}],"title":"Cognitive functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.85","upperLimit":"11.86","value":"8.97"},{"groupId":"OG001","lowerLimit":"4.14","upperLimit":"5.88","value":"4.93"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"137"}],"units":"Participants"}],"title":"Social functioning"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.11","upperLimit":"9.95","value":"8.21"},{"groupId":"OG001","lowerLimit":"3.19","upperLimit":"4.83","value":"4.04"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"149"}],"units":"Participants"}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.51","upperLimit":"11.86","value":"9.36"},{"groupId":"OG001","lowerLimit":"4.27","upperLimit":"6.31","value":"5.06"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"136"}],"units":"Participants"}],"title":"Nausea and vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.96","upperLimit":"10.41","value":"8.57"},{"groupId":"OG001","lowerLimit":"3.29","upperLimit":"5.16","value":"4.34"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"155"}],"units":"Participants"}],"title":"Pain"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.54","upperLimit":"12.25","value":"9.36"},{"groupId":"OG001","lowerLimit":"4.40","upperLimit":"6.60","value":"5.65"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"title":"Dyspnoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.54","upperLimit":"12.25","value":"9.36"},{"groupId":"OG001","lowerLimit":"4.70","upperLimit":"6.80","value":"5.75"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"129"}],"units":"Participants"}],"title":"Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.70","upperLimit":"10.94","value":"8.34"},{"groupId":"OG001","lowerLimit":"3.94","upperLimit":"6.04","value":"4.66"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"144"}],"units":"Participants"}],"title":"Appetite loss"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.34","upperLimit":"12.12","value":"9.46"},{"groupId":"OG001","lowerLimit":"4.63","upperLimit":"6.67","value":"5.55"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"128"}],"units":"Participants"}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.84","upperLimit":"14.49","value":"10.41"},{"groupId":"OG001","lowerLimit":"4.70","upperLimit":"6.60","value":"5.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"title":"Diarrhoea"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.34","upperLimit":"12.12","value":"9.36"},{"groupId":"OG001","lowerLimit":"5.06","upperLimit":"6.93","value":"6.11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"126"}],"units":"Participants"}],"title":"Financial difficulties"}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"155"}],"units":"Participants"}],"description":"EORTC QLQ-C30: 30 item questionnaires with 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (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 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 and 'number analyzed' = participants with available data for each specified category.","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 Sub-scale Scores - Kaplan-Meier Analysis","type":"SECONDARY","unitOfMeasure":"months"}