{"analyses":[{"ciLowerLimit":"3.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.55","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","paramType":"Odds Ratio (OR)","paramValue":"5.79","statisticalComment":"Two-sided Wald's Chi-square test (stratified)","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"80"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"120"}],"units":"Participants"}],"description":"Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1 per central review assessment.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Response Evaluable Analysis Set","reportingStatus":"POSTED","timeFrame":"From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 32 months (Primary Analysis cut-off date = 27-Jan-2021)","title":"Disease Control Rate (DCR)","type":"SECONDARY","unitOfMeasure":"Participants"}