{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.63","value":"3.6"},{"groupId":"OG001","spread":"17.85","value":"-7.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"304"},{"groupId":"OG001","value":"100"}],"units":"Participants"}],"title":"Cycle 2, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.48","value":"3.8"},{"groupId":"OG001","spread":"14.00","value":"-2.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"269"},{"groupId":"OG001","value":"52"}],"units":"Participants"}],"title":"Cycle 3, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.93","value":"5.4"},{"groupId":"OG001","spread":"18.40","value":"-1.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Cycle 4, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.24","value":"4.0"},{"groupId":"OG001","spread":"27.83","value":"-5.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"181"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Cycle 5, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.22","value":"4.1"},{"groupId":"OG001","spread":"26.87","value":"-5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"title":"Cycle 6, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.47","value":"4.9"},{"groupId":"OG001","spread":"17.89","value":"-2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Cycle 7, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.87","value":"3.8"},{"groupId":"OG001","spread":"32.76","value":"-13.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Cycle 8, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.22","value":"3.8"},{"groupId":"OG001","spread":"5.92","value":"6.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"title":"Cycle 9, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.27","value":"0.0"},{"groupId":"OG001","spread":"14.14","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Cycle 10, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.99","value":"-0.8"},{"groupId":"OG001","spread":"33.71","value":"8.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"Cycle 11, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.11","value":"10.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Cycle 12, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"comment":"NA: Only one participant analyzed","groupId":"OG000","spread":"NA","value":"30.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Cycle 13, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.64","value":"-9.4"},{"groupId":"OG001","spread":"18.59","value":"-10.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"161"},{"groupId":"OG001","value":"86"}],"units":"Participants"}],"title":"End of Treatment (EoT) change from BL"}],"denoms":[{"counts":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"The FACT-P total score (range 0-156) consist of five subscales (Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24)) and a functional well-being and prostate cancer subscale (range 0-48). Higher scores indicate higher degree of functioning and better quality of life.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"PFS Full Analysis Set (PFS-FAS). Only participants with non-missing score both at Baseline and at post-baseline visits were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Baseline (BL), Cycle 2 to Cycle 13 (Week 1 Day 1), End of Treatment (EoT) (cycle duration for Cycle 1-6 = 6 weeks and for Cycle 7 and beyond = 12 weeks)","title":"Change From Baseline in FACT-P (Functional Assessment of Cancer Therapy - Prostate) Total Score","type":"SECONDARY","unitOfMeasure":"Score on a scale"}