{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.237","value":"2.13"},{"groupId":"OG001","spread":"15.154","value":"1.58"},{"groupId":"OG002","spread":"14.930","value":"0.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"100"},{"groupId":"OG002","value":"91"}],"units":"Participants"}],"title":"Cycle 2, Day 1 (C2D1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.598","value":"4.65"},{"groupId":"OG001","spread":"18.310","value":"2.75"},{"groupId":"OG002","spread":"16.525","value":"2.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"85"}],"units":"Participants"}],"title":"C3D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.505","value":"6.22"},{"groupId":"OG001","spread":"20.383","value":"3.00"},{"groupId":"OG002","spread":"17.446","value":"2.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"89"},{"groupId":"OG002","value":"75"}],"units":"Participants"}],"title":"C4D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.385","value":"3.31"},{"groupId":"OG001","spread":"18.414","value":"4.72"},{"groupId":"OG002","spread":"18.957","value":"0.32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"52"}],"units":"Participants"}],"title":"C5D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.302","value":"5.63"},{"groupId":"OG001","spread":"19.356","value":"3.38"},{"groupId":"OG002","spread":"20.552","value":"-1.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"C6D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.965","value":"6.87"},{"groupId":"OG001","spread":"22.005","value":"1.80"},{"groupId":"OG002","spread":"16.399","value":"-3.79"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"11"}],"units":"Participants"}],"title":"C9D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.019","value":"4.44"},{"groupId":"OG001","spread":"20.650","value":"9.15"},{"groupId":"OG002","spread":"13.486","value":"-3.57"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"7"}],"units":"Participants"}],"title":"C12D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.769","value":"7.35"},{"groupId":"OG001","spread":"19.325","value":"9.40"},{"groupId":"OG002","spread":"13.608","value":"-5.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"C15D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.606","value":"6.73"},{"groupId":"OG001","spread":"20.983","value":"14.44"},{"groupId":"OG002","spread":"13.944","value":"-3.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"5"}],"units":"Participants"}],"title":"C18D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.250","value":"22.62"},{"groupId":"OG001","spread":"18.898","value":"4.17"},{"groupId":"OG002","spread":"0.000","value":"-16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"title":"C19D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.176","value":"13.89"},{"groupId":"OG001","spread":"12.199","value":"9.52"},{"groupId":"OG002","spread":"0.000","value":"-16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"title":"C20D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.336","value":"11.36"},{"groupId":"OG001","spread":"20.592","value":"15.71"},{"groupId":"OG002","spread":"13.608","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"4"}],"units":"Participants"}],"title":"C21D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.226","value":"20.00"},{"groupId":"OG001","spread":"9.272","value":"5.95"},{"groupId":"OG002","value":"-16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"title":"C22D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.745","value":"11.67"},{"groupId":"OG001","spread":"4.811","value":"12.50"},{"groupId":"OG002","spread":"11.785","value":"-8.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"title":"C23D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.040","value":"8.33"},{"groupId":"OG001","spread":"23.295","value":"14.29"},{"groupId":"OG002","spread":"9.623","value":"-11.11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"3"}],"units":"Participants"}],"title":"C24D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.694","value":"8.89"},{"groupId":"OG001","spread":"18.285","value":"19.05"},{"groupId":"OG002","spread":"41.944","value":"-22.22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"3"}],"units":"Participants"}],"title":"C27D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.408","value":"10.94"},{"groupId":"OG001","spread":"17.918","value":"13.64"},{"groupId":"OG002","spread":"19.245","value":"-5.56"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"3"}],"units":"Participants"}],"title":"C30D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.429","value":"12.82"},{"groupId":"OG001","spread":"17.543","value":"14.17"},{"groupId":"OG002","spread":"23.570","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"title":"C33D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.713","value":"12.50"},{"groupId":"OG001","spread":"17.936","value":"13.24"},{"groupId":"OG002","value":"16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"title":"C36D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.00"},{"groupId":"OG002","value":"16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"title":"C39D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C40D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.00"},{"groupId":"OG002","value":"16.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"title":"C42D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C45D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C48D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C51D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C54D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C57D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C60D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C63D1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"C66D1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.455","value":"4.05"},{"groupId":"OG001","spread":"21.260","value":"3.14"},{"groupId":"OG002","spread":"20.839","value":"3.87"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"56"}],"units":"Participants"}],"title":"Follow-up 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.785","value":"8.33"},{"groupId":"OG001","value":"33.33"},{"groupId":"OG002","spread":"22.704","value":"3.21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"13"}],"units":"Participants"}],"title":"Follow-up 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.33"},{"groupId":"OG002","spread":"5.893","value":"4.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}],"units":"Participants"}],"title":"Follow-up 3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"102"},{"groupId":"OG002","value":"91"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-\"How would you rate your overall health during the past week?\" and \"How would you rate your overall quality of life during the past week?\"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received cemiplimab plus platinum-based doublet chemotherapy","id":"OG000","title":"Part 1: Cemiplimab + Chemotherapy"},{"description":"Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab","id":"OG001","title":"Part 1: Cemiplimab+AbbrevChemo+Ipilimumab"},{"description":"Participants received platinum-based doublet chemotherapy","id":"OG002","title":"Part 1: Chemotherapy"}],"paramType":"MEAN","populationDescription":"Includes only participants in part 1 with both baseline and at least one post-baseline value. Overall number of participants analysed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint","reportingStatus":"POSTED","timeFrame":"Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months","title":"Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}