{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"67.2"},{"groupId":"OG001","spread":"24.5","value":"66.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"111"}],"units":"Participants"}],"title":"Global health status/QOL Score at Screening"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.4","value":"57.4"},{"groupId":"OG001","spread":"20.4","value":"66.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"82"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"58.4"},{"groupId":"OG001","spread":"17.5","value":"65.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"135"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 17"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.7","value":"60.5"},{"groupId":"OG001","spread":"19.6","value":"65.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 25"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.0","value":"60.4"},{"groupId":"OG001","spread":"18.9","value":"63.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 33"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.6","value":"60.4"},{"groupId":"OG001","spread":"18.5","value":"73.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 41"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.4","value":"60.9"},{"groupId":"OG001","spread":"17.9","value":"69.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 49"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.3","value":"62.4"},{"groupId":"OG001","spread":"20.9","value":"76.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 57"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.9","value":"60.8"},{"groupId":"OG001","spread":"22.8","value":"65.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 65"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"62.0"},{"groupId":"OG001","spread":"21.6","value":"67.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Global health status/QOL Score at Week 73"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.4","value":"47.0"},{"groupId":"OG001","spread":"25.6","value":"60.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"title":"Global health status/QOL Score at Treatment Discontinuation Visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.1","value":"59.8"},{"groupId":"OG001","spread":"18.0","value":"69.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Global health status/QOL Score at 30-Day Safety Follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.2","value":"80.2"},{"groupId":"OG001","spread":"18.7","value":"82.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"111"}],"units":"Participants"}],"title":"Physical functioning Score at Screening"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.3","value":"74.8"},{"groupId":"OG001","spread":"18.4","value":"81.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"83"}],"units":"Participants"}],"title":"Physical functioning Score at Week 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.5","value":"75.3"},{"groupId":"OG001","spread":"20.9","value":"79.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"title":"Physical functioning Score at Week 17"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.8","value":"75.5"},{"groupId":"OG001","spread":"19.9","value":"80.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"Physical functioning Score at Week 25"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.6","value":"76.6"},{"groupId":"OG001","spread":"23.3","value":"81.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"Physical functioning Score at Week 33"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"75.1"},{"groupId":"OG001","spread":"21.9","value":"83.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Physical functioning Score at Week 41"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.0","value":"77.5"},{"groupId":"OG001","spread":"20.5","value":"83.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Physical functioning Score at Week 49"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.4","value":"74.8"},{"groupId":"OG001","spread":"20.7","value":"83.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"Physical functioning Score at Week 57"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"77.2"},{"groupId":"OG001","spread":"20.2","value":"81.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Physical functioning Score at Week 65"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.1","value":"77.2"},{"groupId":"OG001","spread":"25.6","value":"78.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Physical functioning Score at Week 73"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.8","value":"66.6"},{"groupId":"OG001","spread":"25.0","value":"71.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"title":"Physical functioning Score at Treatment Discontinuation Visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.5","value":"71.7"},{"groupId":"OG001","spread":"23.4","value":"78.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Physical functioning Score at 30-Day Safety Follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.2","value":"75.8"},{"groupId":"OG001","spread":"24.0","value":"71.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"111"}],"units":"Participants"}],"title":"Emotional functioning Score at Screening"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.6","value":"73.1"},{"groupId":"OG001","spread":"22.9","value":"75.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"82"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.2","value":"73.9"},{"groupId":"OG001","spread":"19.1","value":"77.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 17"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.0","value":"76.7"},{"groupId":"OG001","spread":"20.9","value":"78.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 25"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.6","value":"75.1"},{"groupId":"OG001","spread":"20.4","value":"81.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 33"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.0","value":"74.7"},{"groupId":"OG001","spread":"24.9","value":"79.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 41"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.6","value":"77.6"},{"groupId":"OG001","spread":"24.0","value":"79.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 49"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.7","value":"77.7"},{"groupId":"OG001","spread":"26.6","value":"81.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 57"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.6","value":"77.1"},{"groupId":"OG001","spread":"28.7","value":"80.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 65"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.5","value":"73.4"},{"groupId":"OG001","spread":"31.5","value":"69.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Emotional functioning Score at Week 73"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.2","value":"63.6"},{"groupId":"OG001","spread":"23.2","value":"70.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"title":"Emotional functioning Score at Treatment Discontinuation Visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.7","value":"70.5"},{"groupId":"OG001","spread":"17.4","value":"82.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Emotional functioning Score at 30-Day Safety Follow-up"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.9","value":"79.9"},{"groupId":"OG001","spread":"24.8","value":"79.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"111"}],"units":"Participants"}],"title":"Social functioning Score at Screening"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.0","value":"69.5"},{"groupId":"OG001","spread":"28.0","value":"76.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"179"},{"groupId":"OG001","value":"82"}],"units":"Participants"}],"title":"Social functioning Score at Week 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.8","value":"75.6"},{"groupId":"OG001","spread":"23.9","value":"77.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"68"}],"units":"Participants"}],"title":"Social functioning Score at Week 17"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.3","value":"78.7"},{"groupId":"OG001","spread":"23.2","value":"76.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"title":"Social functioning Score at Week 25"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.8","value":"76.0"},{"groupId":"OG001","spread":"26.5","value":"79.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"Social functioning Score at Week 33"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.0","value":"73.4"},{"groupId":"OG001","spread":"25.5","value":"83.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"title":"Social functioning Score at Week 41"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.6","value":"78.5"},{"groupId":"OG001","spread":"16.1","value":"81.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"title":"Social functioning Score at Week 49"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.2","value":"74.0"},{"groupId":"OG001","spread":"27.1","value":"77.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"16"}],"units":"Participants"}],"title":"Social functioning Score at Week 57"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.9","value":"78.3"},{"groupId":"OG001","spread":"31.9","value":"72.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Social functioning Score at Week 65"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.4","value":"75.5"},{"groupId":"OG001","spread":"28.2","value":"75.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"Social functioning Score at Week 73"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.7","value":"63.5"},{"groupId":"OG001","spread":"31.2","value":"66.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"title":"Social functioning Score at Treatment Discontinuation Visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.9","value":"71.1"},{"groupId":"OG001","spread":"27.2","value":"78.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Social functioning Score at 30-Day Safety Follow-up"}],"denoms":[{"counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"113"}],"units":"Participants"}],"description":"EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a global health status/quality of life (QOL) scale, and 6 single-item scales. The global health status/QOL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for global health status/QOL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. In this study, global health status/QOL scale score was identified as the primary patient-reported outcome variable of interest. Physical functioning, emotional functioning, and social functioning scale scores were considered as secondary. Higher scores indicate better quality of life.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.","id":"OG000","title":"MEK 162"},{"description":"Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.","id":"OG001","title":"Physician's Choice"}],"paramType":"MEAN","populationDescription":"Analysis population included all randomized participants (228 participants in MEK162 group, 113 participants in physician's choice group).","reportingStatus":"POSTED","timeFrame":"Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit","title":"Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}