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These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.","groupDescription":"Financial Impact change from baseline","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5717","paramType":"Mean Difference (Final Values)","paramValue":"-1.7","statisticalMethod":"ANCOVA","testedNonInferiority":false},{"ciLowerLimit":"-5.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.4","estimateComment":"Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.","groupDescription":"Financial Impact change from baseline","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6949","paramType":"Mean Difference (Final Values)","paramValue":"1.4","statisticalMethod":"ANCOVA","testedNonInferiority":false},{"ciLowerLimit":"-8.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.6","estimateComment":"Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.","groupDescription":"Financial Impact change from baseline","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2849","paramType":"Mean Difference (Final Values)","paramValue":"-3.1","statisticalMethod":"ANCOVA","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-10.4","upperLimit":"-4.3","value":"-7.4"},{"groupId":"OG001","lowerLimit":"-13.5","upperLimit":"-4.1","value":"-8.8"},{"groupId":"OG002","lowerLimit":"-15.3","upperLimit":"-5.5","value":"-10.4"}]}],"title":"Global QOL (n=226, 83, 77)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-8.9","upperLimit":"-3.4","value":"-6.2"},{"groupId":"OG001","lowerLimit":"-9.4","upperLimit":"-0.8","value":"-5.1"},{"groupId":"OG002","lowerLimit":"-14.5","upperLimit":"-5.7","value":"-10.1"}]}],"title":"Physical (n=226 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-13.4","upperLimit":"-5.3","value":"-9.3"},{"groupId":"OG001","lowerLimit":"-16.8","upperLimit":"-4.1","value":"-10.5"},{"groupId":"OG002","lowerLimit":"-20.2","upperLimit":"-7.2","value":"-13.7"}]}],"title":"Role Change (n=226, 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.8","upperLimit":"-0.3","value":"-3.1"},{"groupId":"OG001","lowerLimit":"-8.6","upperLimit":"0.0","value":"-4.3"},{"groupId":"OG002","lowerLimit":"-7.8","upperLimit":"1.0","value":"-3.4"}]}],"title":"Cognitive (n=226, 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-4.2","upperLimit":"1.1","value":"-1.5"},{"groupId":"OG001","lowerLimit":"-7.7","upperLimit":"0.6","value":"-3.6"},{"groupId":"OG002","lowerLimit":"-5.8","upperLimit":"2.7","value":"-1.5"}]}],"title":"Emotional (n=227, 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-9.2","upperLimit":"-2.0","value":"-5.6"},{"groupId":"OG001","lowerLimit":"-13.2","upperLimit":"-1.9","value":"-7.5"},{"groupId":"OG002","lowerLimit":"-10.1","upperLimit":"1.8","value":"-4.2"}]}],"title":"Social (n=227, 83, 76)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.0","upperLimit":"14.1","value":"10.6"},{"groupId":"OG001","lowerLimit":"7.0","upperLimit":"18.1","value":"12.5"},{"groupId":"OG002","lowerLimit":"8.8","upperLimit":"20.2","value":"14.5"}]}],"title":"Fatigue (n=226, 82, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.9","upperLimit":"7.3","value":"4.6"},{"groupId":"OG001","lowerLimit":"-1.0","upperLimit":"7.3","value":"3.1"},{"groupId":"OG002","lowerLimit":"0.1","upperLimit":"8.7","value":"4.4"}]}],"title":"Nausea and Vomiting (n=226, 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.0","upperLimit":"9.3","value":"5.6"},{"groupId":"OG001","lowerLimit":"2.2","upperLimit":"13.6","value":"7.9"},{"groupId":"OG002","lowerLimit":"6.0","upperLimit":"17.7","value":"11.9"}]}],"title":"Pain (n=227, 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"6.9","value":"3.5"},{"groupId":"OG001","lowerLimit":"-0.1","upperLimit":"10.7","value":"5.3"},{"groupId":"OG002","lowerLimit":"3.6","upperLimit":"14.6","value":"9.1"}]}],"title":"Dyspnea (n=222, 81, 77)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.3","upperLimit":"10.7","value":"6.5"},{"groupId":"OG001","lowerLimit":"3.6","upperLimit":"16.6","value":"10.1"},{"groupId":"OG002","lowerLimit":"4.3","upperLimit":"17.8","value":"11.0"}]}],"title":"Sleep Disturbance (n=225, 83, 76)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.4","upperLimit":"12.5","value":"8.5"},{"groupId":"OG001","lowerLimit":"5.3","upperLimit":"17.9","value":"11.6"},{"groupId":"OG002","lowerLimit":"3.8","upperLimit":"16.8","value":"10.3"}]}],"title":"Appetite Loss (n=225, 83, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.7","upperLimit":"8.7","value":"5.2"},{"groupId":"OG001","lowerLimit":"-3.5","upperLimit":"7.2","value":"1.9"},{"groupId":"OG002","lowerLimit":"6.2","upperLimit":"17.4","value":"11.8"}]}],"title":"Constipation (n=225, 83, 77)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"10.1","value":"6.4"},{"groupId":"OG001","lowerLimit":"3.4","upperLimit":"14.7","value":"9.1"},{"groupId":"OG002","lowerLimit":"-3.7","upperLimit":"7.9","value":"2.1"}]}],"title":"Diarrhea (n=223, 82, 78)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-3.2","upperLimit":"3.2","value":"0.0"},{"groupId":"OG001","lowerLimit":"-1.9","upperLimit":"8.1","value":"3.1"},{"groupId":"OG002","lowerLimit":"-3.5","upperLimit":"6.9","value":"1.7"}]}],"title":"Financial Impact (n=226, 83, 76)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"381"},{"groupId":"OG001","value":"131"},{"groupId":"OG002","value":"131"}],"units":"Participants"}],"description":"The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).","dispersionType":"95% Confidence Interval","groups":[{"description":"Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\\[288V\\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\\[210M\\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.","id":"OG000","title":"Ipilimumab Plus gp100"},{"description":"Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.","id":"OG001","title":"Ipilimumab Monotherapy"},{"description":"Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\\[288V\\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\\[210M\\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.","id":"OG002","title":"gp100"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.","reportingStatus":"POSTED","timeFrame":"Baseline (Day 1, Cycle1), Week 12","title":"Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12","type":"SECONDARY","unitOfMeasure":"units on a scale"}