{"analyses":[{"ciLowerLimit":"0.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.74","groupDescription":"Primary OS Analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalComment":"one-sided stratified log-rank test","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.81","estimateComment":"Cox PH model stratified by LDH (≤260 vs. \\>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification","groupDescription":"Final OS analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"0.68"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.2","upperLimit":"16.9","value":"15.3"},{"groupId":"OG001","lowerLimit":"9.8","upperLimit":"13.5","value":"11.3"}]}],"title":"Primary OS Analysis"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.2","upperLimit":"16.9","value":"15.3"},{"groupId":"OG001","lowerLimit":"9.9","upperLimit":"13.5","value":"11.5"}]}],"title":"Final OS analysis"}],"denoms":[{"counts":[{"groupId":"OG000","value":"551"},{"groupId":"OG001","value":"280"}],"units":"Participants"}],"description":"Overall Survival (OS) was defined as the time (in months) from the date of randomization to the date of death due to any cause. If the patient was not known to have died, then OS was censored. The censoring date was date of the last study visit, or contact, until the cut-off date. The cut-off date was not used for last contact date, unless the patient was seen or contacted on that date.\n\nFinal OS was analyzed at the time of Primary analysis (Primary Analysis cut-off date = 27-Jan-2021) and an updated descriptive analysis of OS was re-run at the time of final analysis (Final Analysis cut-off date 14-Dec-2023).","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":"Full Analysis Set (FAS)","reportingStatus":"POSTED","timeFrame":"From date of randomization until date of death from any cause, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021) and up to 66 months (Final Analysis cut-off date = 14-Dec-2023)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}