{"analyses":[{"ciLowerLimit":"8.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"65.1","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","paramType":"Odds Ratio (OR)","paramValue":"23.6","statisticalComment":"Two-sided Wald's Chi-square test (stratified)","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.3","upperLimit":"37.9","value":"33.0"},{"groupId":"OG001","lowerLimit":"0.6","upperLimit":"5.1","value":"2.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"PSA80 response was defined as the proportion of participants who had a \\>= 80% decrease in PSA from baseline confirmed by a PSA measurement \\>= 4 weeks later.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used","id":"OG000","title":"Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)"},{"description":"Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator","id":"OG001","title":"Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone"}],"paramType":"NUMBER","populationDescription":"PFS Full Analysis Set (PFS-FAS)","reportingStatus":"POSTED","timeFrame":"From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)","title":"Prostate-specific Antigen 80 (PSA80) Response","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}