{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.62","value":"-2.6"},{"groupId":"OG001","spread":"14.52","value":"-4.9"},{"groupId":"OG002","spread":"14.09","value":"-5.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"233"},{"groupId":"OG001","value":"183"},{"groupId":"OG002","value":"221"}],"units":"Participants"}],"title":"Week 5 (n= 233, 183, 221)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.53","value":"-2.4"},{"groupId":"OG001","spread":"14.92","value":"-5.3"},{"groupId":"OG002","spread":"14.69","value":"-5.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"183"},{"groupId":"OG002","value":"218"}],"units":"Participants"}],"title":"Week 7 (n= 239, 183, 218)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.14","value":"-2.4"},{"groupId":"OG001","spread":"13.76","value":"-5.6"},{"groupId":"OG002","spread":"14.72","value":"-6.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"112"},{"groupId":"OG002","value":"163"}],"units":"Participants"}],"title":"Week 11 (n= 201, 112, 163)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.79","value":"-1.7"},{"groupId":"OG001","spread":"14.11","value":"-4.3"},{"groupId":"OG002","spread":"17.47","value":"-5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"106"},{"groupId":"OG002","value":"130"}],"units":"Participants"}],"title":"Week 13 (n= 195, 106, 130)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.82","value":"-1.4"},{"groupId":"OG001","spread":"17.27","value":"-6.7"},{"groupId":"OG002","spread":"13.46","value":"-3.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"104"}],"units":"Participants"}],"title":"Week 17 (n= 158, 84, 104)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.14","value":"0.4"},{"groupId":"OG001","spread":"14.34","value":"-3.7"},{"groupId":"OG002","spread":"17.70","value":"-4.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"98"}],"units":"Participants"}],"title":"Week 19 (n= 164, 96, 98)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.87","value":"0.9"},{"groupId":"OG001","spread":"15.59","value":"-4.0"},{"groupId":"OG002","spread":"15.04","value":"-5.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"75"}],"units":"Participants"}],"title":"Week 23 (n= 134, 86, 75)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.02","value":"1.4"},{"groupId":"OG001","spread":"14.28","value":"-4.2"},{"groupId":"OG002","spread":"16.19","value":"-3.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"144"},{"groupId":"OG001","value":"97"},{"groupId":"OG002","value":"75"}],"units":"Participants"}],"title":"Week 25 (n= 144, 97, 75)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.60","value":"1.9"},{"groupId":"OG001","spread":"12.91","value":"-2.4"},{"groupId":"OG002","spread":"14.62","value":"-2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"51"}],"units":"Participants"}],"title":"Week 31 (n= 123, 92, 51)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.57","value":"2.1"},{"groupId":"OG001","spread":"13.00","value":"-0.8"},{"groupId":"OG002","spread":"13.71","value":"-2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"88"},{"groupId":"OG002","value":"48"}],"units":"Participants"}],"title":"Week 37 (n= 116, 88, 48)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.16","value":"1.9"},{"groupId":"OG001","spread":"13.55","value":"-0.5"},{"groupId":"OG002","spread":"12.71","value":"-1.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"44"}],"units":"Participants"}],"title":"Week 43 (n= 103, 74, 44)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.08","value":"1.3"},{"groupId":"OG001","spread":"12.97","value":"-0.1"},{"groupId":"OG002","spread":"12.31","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"40"}],"units":"Participants"}],"title":"Week 49 (n= 97, 70, 40)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.68","value":"1.8"},{"groupId":"OG001","spread":"13.24","value":"-2.9"},{"groupId":"OG002","spread":"10.57","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"34"}],"units":"Participants"}],"title":"Week 55 (n= 86, 66, 34)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.65","value":"0.2"},{"groupId":"OG001","spread":"13.91","value":"-2.1"},{"groupId":"OG002","spread":"11.35","value":"-0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"title":"Week 61 (n= 85, 61, 31)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.44","value":"0.9"},{"groupId":"OG001","spread":"13.22","value":"-1.7"},{"groupId":"OG002","spread":"10.62","value":"-3.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"29"}],"units":"Participants"}],"title":"Week 67 (n= 76, 61, 29)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.38","value":"0.5"},{"groupId":"OG001","spread":"11.27","value":"-3.5"},{"groupId":"OG002","spread":"7.80","value":"-3.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"19"}],"units":"Participants"}],"title":"Week 73 (n= 67, 54, 19)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.99","value":"-1.7"},{"groupId":"OG001","spread":"17.09","value":"-4.3"},{"groupId":"OG002","spread":"6.54","value":"-1.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"21"}],"units":"Participants"}],"title":"Week 79 (n= 67, 54, 21)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.86","value":"-1.6"},{"groupId":"OG001","spread":"12.88","value":"-3.5"},{"groupId":"OG002","spread":"6.11","value":"-2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"18"}],"units":"Participants"}],"title":"Week 85 (n= 68, 51, 18)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.27","value":"-0.4"},{"groupId":"OG001","spread":"14.45","value":"-4.2"},{"groupId":"OG002","spread":"0.00","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"16"}],"units":"Participants"}],"title":"Week 91 (n= 62, 53, 16)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.79","value":"-0.4"},{"groupId":"OG001","spread":"16.53","value":"-4.4"},{"groupId":"OG002","spread":"4.00","value":"-0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"Week 97 (n= 58, 49, 17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.18","value":"-1.5"},{"groupId":"OG001","spread":"15.63","value":"-5.4"},{"groupId":"OG002","spread":"7.05","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"Week 103 (n= 53, 46, 17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.74","value":"1.7"},{"groupId":"OG001","spread":"13.92","value":"-1.2"},{"groupId":"OG002","spread":"3.56","value":"-1.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"14"}],"units":"Participants"}],"title":"Week 109 (n= 44, 39, 14)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.20","value":"0.2"},{"groupId":"OG001","spread":"15.10","value":"-2.0"},{"groupId":"OG002","spread":"3.23","value":"-0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"Week 115 (n= 44, 36, 17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.77","value":"-0.3"},{"groupId":"OG001","spread":"13.58","value":"-3.4"},{"groupId":"OG002","spread":"5.37","value":"-2.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"16"}],"units":"Participants"}],"title":"Week 121 (n= 44, 39, 16)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.21","value":"1.2"},{"groupId":"OG001","spread":"16.75","value":"-3.0"},{"groupId":"OG002","spread":"5.75","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"17"}],"units":"Participants"}],"title":"Week 127 (n= 47, 36, 17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.33","value":"0.2"},{"groupId":"OG001","spread":"14.40","value":"0.4"},{"groupId":"OG002","spread":"6.16","value":"-2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"11"}],"units":"Participants"}],"title":"Week 133 (n= 29, 31, 11)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.94","value":"0.4"},{"groupId":"OG001","spread":"11.40","value":"-3.9"},{"groupId":"OG002","spread":"5.58","value":"-3.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"Week 139 (n= 20, 19, 6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.94","value":"-1.4"},{"groupId":"OG001","spread":"9.06","value":"-6.7"},{"groupId":"OG002","spread":"8.43","value":"-6.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"title":"Week 145 (n= 14, 14, 6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.52","value":"8.6"},{"groupId":"OG001","spread":"12.68","value":"-9.5"},{"comment":"No SD calculated; only one patient analyzed","groupId":"OG002","spread":"NA","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"}],"units":"Participants"}],"title":"Week 151 (n= 7, 7, 1)"},{"categories":[{"measurements":[{"comment":"No SD calculated; only one patient analyzed","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"25.24","value":"-17.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Week 157 (n= 1, 3, 0)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"315"}],"units":"Participants"}],"description":"Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.","dispersionType":"Standard Deviation","groups":[{"description":"Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity","id":"OG000","title":"Nivolumab"},{"description":"Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity","id":"OG001","title":"Nivolumab + Ipilimumab"},{"description":"Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses","id":"OG002","title":"Ipilimumab"}],"paramType":"MEAN","populationDescription":"All randomized participants. Only participants with evaluable EORTC scores at baseline and at particular timepoint are considered in the analysis.","reportingStatus":"POSTED","timeFrame":"Baseline (Day 1) and Week 5, 7, 11, 13, 17, 19, 23, 25, 31, 37, 43, 49, 55, 61, 67, 73, 79, 85, 91, 97, 103, 109, 115, 121, 127, 133, 139, 145, 151 and 157","title":"Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning","type":"SECONDARY","unitOfMeasure":"Points on EORTC scale"}