{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.62","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.50","statisticalComment":"Two-sided stratified log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.3","upperLimit":"13.2","value":"11.5"},{"groupId":"OG001","lowerLimit":"5.2","upperLimit":"8.5","value":"6.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"Time to first Symptomatic Skeletal Event (SSE) was defined as the time (in months) from the date of randomization to the date of the SSE or death from any cause. The SSE date was the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. SSE data for this endpoint were collected up through EOT visit. The censoring date was date of the last study visit (on or before the EOT visit).","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 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":"Time to First Symptomatic Skeletal Event (SSE)","type":"SECONDARY","unitOfMeasure":"Months"}