{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.","groups":[{"description":"Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"MDX-010"}],"populationDescription":"No participants proceeded to Phase 2 for evaluation.","reportingStatus":"POSTED","timeFrame":"From registration to progression (up to 2 years)","title":"Time to Progression (Phase 2)","type":"SECONDARY"}