{"classes":[{"categories":[{"measurements":[{"comment":"insufficient number of participants to calculate CI","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"29"},{"groupId":"OG002","lowerLimit":"29","upperLimit":"88","value":"58.5"},{"groupId":"OG003","lowerLimit":"22","upperLimit":"57","value":"29"}]}],"title":"Time to PSA Progression"},{"categories":[{"measurements":[{"comment":"insufficient number of participants to calculate CI","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"29"},{"groupId":"OG002","lowerLimit":"29","upperLimit":"88","value":"58.5"},{"groupId":"OG003","lowerLimit":"22","upperLimit":"57","value":"29"}]}],"title":"PSA Progression Free Survival"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"5"}],"units":"Participants"}],"description":"Time to PSA progression: first dose to first PSA progression. Missing date of progression was censored: if death during the study, time to progression was right-censored at last PSA assessment; if no progression from first dose and still alive at end of study, time to progression was right-censored at last PSA assessment by end of study; if no PSA progression and one has discontinued from the study (other than death or PSA progression), time to progression was right-censored at last PSA assessment. PSA progression free survival (PFS): first dose to first PSA progression or death, whichever comes first. Missing date of progression was censored: if one did not have PSA progression from first dose and was still alive at end of study, PSA PFS was right-censored at last PSA assessment; if one does not have any progression and discontinued from the study for reasons other than death or progression, PFS was right-censored at last assessment. CI computed using Brookmeyer and Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG000","title":"0.3 mg/kg Nivolumab"},{"description":"1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG001","title":"1 mg/kg Nivolumab"},{"description":"3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG002","title":"3 mg/kg Nivolumab"},{"description":"10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG003","title":"10 mg/kg Nivolumab"}],"paramType":"MEDIAN","populationDescription":"The PSA evaluable population include all participants in the study who received complete dose(s) of nivolumab and had a baseline PSA assessment and at least 1 post-baseline PSA assessment.","reportingStatus":"POSTED","timeFrame":"Day 1 to 2 Years","title":"Median Time to PSA Progression in Days and Median PSA Progression Free Survival in Days in PSA Evaluable Population","type":"SECONDARY","unitOfMeasure":"days"}