{"analyses":[{"ciLowerLimit":"0.24","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.38","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","paramType":"Cox Proportional Hazard","paramValue":"0.30","statisticalComment":"Two-sided stratified log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.2","upperLimit":"6.6","value":"5.9"},{"groupId":"OG001","lowerLimit":"2.2","upperLimit":"3.0","value":"2.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time (in months) from the date of randomization to the date of first evidence of radiographic, clinical or PSA progression or death due to any cause, whichever occurred first.","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":"MEDIAN","populationDescription":"PFS Full Analysis Set (PFS-FAS)","reportingStatus":"POSTED","timeFrame":"From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}