{"analyses":[{"groupDescription":"This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).","groupIds":["OG000","OG001"],"nonInferiorityComment":"This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.","nonInferiorityType":"SUPERIORITY","pValue":"0.044","statisticalComment":"Stratified logrank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.62","upperLimit":"0.72","value":"0.67"},{"groupId":"OG001","lowerLimit":"0.68","upperLimit":"0.76","value":"0.72"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"528"},{"groupId":"OG001","value":"523"}],"units":"Participants"}],"description":"Overall survival is defined as the time from randomization to death or date last known alive.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","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":"OG001","title":"Arm C (LIP)"}],"paramType":"NUMBER","populationDescription":"Concurrently randomized patients on Arms B and C","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months for 2 years, then every 6 months for years 3-5","title":"5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])","type":"PRIMARY","unitOfMeasure":"proportion of participants"}