{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.58","estimateComment":"Reference level = placebo arm","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.48","statisticalComment":"One-sided test","statisticalMethod":"Gray's test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"62.7","upperLimit":"72.5","value":"67.9"},{"groupId":"OG001","lowerLimit":"38.8","upperLimit":"49.1","value":"44.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"376"},{"groupId":"OG001","value":"384"}],"units":"Participants"}],"description":"Second PSA recurrence (SPSAR) rates (i.e. first PSA failure on study) were estimated by the cumulative incidence method, with failure defined as the first occurrence of one of the following events: 1. Increase in PSA following protocol treatment according to the following criteria met during protocol treatment: If PSA dropped to undetectable level (\\<0.2 ng/ml) during protocol treatment (PT) then failure = increase after PT to \\>= 0.5 ng/ml ; If PSA decreased to a detectable level (≥ 0.2 ng/ml) during PT, then failure = increase PT of \\>= 0.3 ng/ml above the lowest detectable level; If PSA did not decrease during PT then failure = increase in PSA after PT of \\>= 0.5 ng/ml above entry PSA level. 2. The start of salvage hormone therapy. Patients alive without SPSAR at time of analysis were censored. Death without SPSAR was treated as a competing risk. Four-year follow-up was required of all patients, but twelve-year rates were reported. Patients are followed until death.","dispersionType":"95% Confidence Interval","groups":[{"description":"Radiation therapy (64.8 Gy) + placebo (daily 2 years)","id":"OG000","title":"Placebo"},{"description":"Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)","id":"OG001","title":"Bicalutamide"}],"paramType":"NUMBER","populationDescription":"Eligible patients who did not withdraw consent.","reportingStatus":"POSTED","timeFrame":"From date of randomization to 12 years.","title":"Second PSA Recurrence (12-year Rates Reported)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}