{"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.","groupId":"OG000","lowerLimit":"2.9","upperLimit":"NA","value":"3.9"},{"groupId":"OG001","lowerLimit":"1.6","upperLimit":"3.0","value":"2.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"511"},{"groupId":"OG001","value":"478"}],"units":"Participants"}],"description":"Recurrence-free survival is defined as the time from randomization to recurrence or death, whichever occurs first. The following criteria constitute the only acceptable evidence of disease recurrence.\n\nLung and liver: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease.\n\nCentral Nervous System: A positive brain CT or MRI scan or CSF cytology. Cutaneous, Subcutaneous and Lymph Node Recurrence: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease.\n\nBone and Other Organs: Positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease identified on two different radiologic studies: i.e., positive nuclear bone scan or PET scan and contrast GI series or ultrasound, X-ray or CT of abdomen for abdominal disease.","dispersionType":"95% Confidence Interval","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)"}],"paramType":"MEDIAN","populationDescription":"Concurrently randomized patients on Arms A and B","reportingStatus":"POSTED","timeFrame":"Assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years","title":"Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])","type":"PRIMARY","unitOfMeasure":"years"}