{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"-8.3"},{"groupId":"OG001","spread":"20.4","value":"-22.7"},{"groupId":"OG002","spread":"18.9","value":"-6.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"97"}],"units":"Participants"}],"description":"The Functional Assessment of Cancer Therapy - Biologic Response Modifiers (FACT-BRM) is a questionnaire including FACT-G (The Functional Assessment of Cancer Therapy - General) and additional sections addressing physical and mental quality of life aspects. It is a 40-item questionnaire with a scale of 0-4. The FACT-BRM total score ranges between 0 and 160. The higher the score, the better the quality of life. Change in FACT-BRM total score from baseline to 3 months is calculated as month 3 score - baseline score.","dispersionType":"Standard Deviation","groups":[{"description":"Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A (HIP)"},{"description":"Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Arm B (HDI)"},{"description":"Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Arm C (LIP)"}],"paramType":"MEAN","populationDescription":"Patients with baseline and 3-month FACT-BRM assessments were included in this analysis. Pediatric patients did not participate in the quality of life part of the study.","reportingStatus":"POSTED","timeFrame":"Assessed at baseline and 3 months","title":"Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months","type":"SECONDARY","unitOfMeasure":"score on a scale"}