{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.9","value":"-3.7"},{"groupId":"OG001","spread":"2.7","value":"-0.7"},{"groupId":"OG002","spread":"5.1","value":"-2.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"109"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"97"}],"units":"Participants"}],"description":"The diarrhea subscale of The Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) is an 11-item questionnaire with a scale of 0-4. The FACIT-D diarrhea subscale score ranges between 0 and 44. The higher the score, the better the quality of life. Change in FACIT-D diarrhea subscale score from baseline to 3 months was 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 FACIT-D diarrhea subscale 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 FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months","type":"SECONDARY","unitOfMeasure":"score on a scale"}