{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"15.9","value":"5.8"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"10.8","value":"7.1"}]}],"title":"Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"15.8","value":"5.6"},{"groupId":"OG001","lowerLimit":"8.8","upperLimit":"17.0","value":"12.9"}]}],"title":"Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"19.0","value":"7.4"},{"groupId":"OG001","lowerLimit":"10.5","upperLimit":"21.2","value":"15.9"}]}],"title":"Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"28.4","value":"14.8"},{"groupId":"OG001","lowerLimit":"13.3","upperLimit":"26.1","value":"19.7"}]}],"title":"Cycle 4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"36"}],"units":"Participants"}],"description":"Will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) symptom score. The QLQ-C30 questionnaire is made up of 30 questions and contains five functional scales (physical, role, emotional, cognitive, and social functioning), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), and six single items (appetite loss, diarrhea, dyspnea, constipation, insomnia, and financial impact). The questionnaire uses a four-point response scale (\"not at all\", \"a little\", \"quite a bit\", and \"very much\"), with the exception of the global QoL scale, which has a seven-point response format. The scores were linearly transformed to a score between 0 and 100. For the functioning and the global QoL scales, a higher score indicates better health. For the symptoms scales, a higher score indicates more symptom burden. Linearly transformed scores for the nausea and vomiting item are reported here.","dispersionType":"95% Confidence Interval","groups":[{"description":"Responders were defined as patients who reached an objective tumour response (eg, partial or complete response) according to RECIST by cycle four","id":"OG000","title":"Responders"},{"description":"Non-responders were defined as patients who did not reach an objective tumour response (eg, partial or complete response) according to RECIST by cycle four","id":"OG001","title":"Non-responders"}],"paramType":"MEAN","populationDescription":"This objective was analyzed differently to investigate the link between symptom burden and treatment response; therefore, results are reported by response status (responders vs non-responders).","reportingStatus":"POSTED","timeFrame":"Outcomes are measured at Cycle 1 to Cycle 4 between responders and non-responders","title":"Subject-reported Outcomes","type":"SECONDARY","unitOfMeasure":"score on a scale"}