{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.96","value":"-2.29"},{"groupId":"OG001","spread":"14.02","value":"1.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"400"},{"groupId":"OG001","value":"421"}],"units":"Participants"}],"title":"Week 4 Day 22"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.44","value":"-6.64"},{"groupId":"OG001","spread":"16.75","value":"-0.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"360"},{"groupId":"OG001","value":"412"}],"units":"Participants"}],"title":"Week 7, Day 43"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.56","value":"-9.06"},{"groupId":"OG001","spread":"16.18","value":"-0.23"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"356"},{"groupId":"OG001","value":"405"}],"units":"Participants"}],"title":"Week 10 Day 64"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.55","value":"-4.33"},{"groupId":"OG001","spread":"17.00","value":"1.37"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"300"},{"groupId":"OG001","value":"347"}],"units":"Participants"}],"title":"Week 24 Day 162 (300, 347)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.32","value":"-5.09"},{"groupId":"OG001","spread":"18.52","value":"1.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"307"}],"units":"Participants"}],"title":"Week 36 Day 246"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.17","value":"-3.67"},{"groupId":"OG001","spread":"18.87","value":"1.54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"276"}],"units":"Participants"}],"title":"Week 48 Day 330"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.34","value":"-5.30"},{"groupId":"OG001","spread":"17.05","value":"2.84"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"242"},{"groupId":"OG001","value":"255"}],"units":"Participants"}],"title":"Week 60 Day 414"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.19","value":"-4.07"},{"groupId":"OG001","spread":"17.46","value":"1.18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"248"}],"units":"Participants"}],"title":"Week 72 day 498"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.06","value":"-3.90"},{"groupId":"OG001","spread":"17.08","value":"1.84"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"205"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"title":"Week 84 Day 582"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.71","value":"-4.48"},{"groupId":"OG001","spread":"18.67","value":"1.36"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"214"}],"units":"Participants"}],"title":"Week 96 Day 666"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.35","value":"-4.27"},{"groupId":"OG001","spread":"16.72","value":"2.45"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"177"}],"units":"Participants"}],"title":"Week 108 Day 750"}],"denoms":[{"counts":[{"groupId":"OG000","value":"400"},{"groupId":"OG001","value":"421"}],"units":"Participants"}],"description":"Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.","dispersionType":"Standard Deviation","groups":[{"description":"Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).","id":"OG000","title":"Ipilimumab 10mg/kg"},{"description":"Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).","id":"OG001","title":"Placebo"}],"paramType":"MEAN","populationDescription":"All randomized participants (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized participants (ITT) with a measurement at the timepoint were analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline up to 2 years from randomization","title":"Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint","type":"SECONDARY","unitOfMeasure":"units on a scale"}