{"analyses":[{"ciLowerLimit":"-12.93","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.80","groupDescription":"Cycle 2 Day 1: Pain","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Least-squares mean difference","paramValue":"-5.1"},{"ciLowerLimit":"-6.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.88","groupDescription":"Cycle 2 Day 1: Appetite Loss","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Least-squares mean difference","paramValue":"0.7"},{"ciLowerLimit":"-5.82","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"14.55","groupDescription":"Cycle 3 Day 1: Pain","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Least-squares mean difference","paramValue":"4.4"},{"ciLowerLimit":"-15.34","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.12","groupDescription":"Cycle 3 Day 1: Appetite Loss","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Least-squares mean difference","paramValue":"-6.1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.94","value":"5.1"},{"groupId":"OG001","spread":"3.49","value":"10.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"Cycle 2 Day 1: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.84","value":"4.3"},{"groupId":"OG001","spread":"3.19","value":"3.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"Cycle 2 Day 1: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.16","value":"2.3"},{"groupId":"OG001","spread":"4.70","value":"-2.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 3 Day 1: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.02","value":"-2.0"},{"groupId":"OG001","spread":"4.24","value":"4.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Cycle 3 Day 1: Appetite Loss"}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"For HRQOL based on QLQ-BIL21, subscales of eating symptoms and pain symptoms were assessed. Each item is a 4-point Likert scale. There are 4 response levels (not at all, a little, quite a bit, and very much). Raw scores are converted into scale scores ranging from 0 to 100. For symptom scales, lower scores=better QOL (negative change from Baseline=improvement).","dispersionType":"Standard Error","groups":[{"description":"Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.","id":"OG000","title":"AG-120"},{"description":"Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.","id":"OG001","title":"Placebo"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"ITT population included all randomized participants, with treatment group designated according to the randomization. Overall Number of Participants Analyzed is the number of participants with data available for analyses at baseline and the given post-baseline timepoints. Number Analyzed at a particular timepoint is the number of participants with data available for analyses at baseline and given timepoint.","reportingStatus":"POSTED","timeFrame":"Cycle 2 Day 1 and Cycle 3 Day 1","title":"Change From Baseline in HRQOL Based on: Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21)","type":"SECONDARY","unitOfMeasure":"score on a scale"}